FDA 21 CFR Part 11 * cGMP * GxP * EMA Requirements * Global Validation Standards * Design compliant ... Coach managers, consultants, and analysts. * Support talent acquisition, performance management ...
FDA 21 CFR Part 11 * cGMP * GxP * EMA Requirements * Global Validation Standards * Design compliant ... Coach managers, consultants, and analysts. * Support talent acquisition, performance management ...
FDA 21 CFR Part 11 * cGMP * GxP * EMA Requirements * Global Validation Standards * Design compliant ... Coach managers, consultants, and analysts. * Support talent acquisition, performance management ...
FDA 21 CFR Part 11 * cGMP * GxP * EMA Requirements * Global Validation Standards * Design compliant ... Coach managers, consultants, and analysts. * Support talent acquisition, performance management ...
Manager, Human Factors (Cincinnati, OH, US, 45241)
Cincinnati, OH · On-site
$120 - $180/hr
... consultants * Experience in additional functional areas (e.g., quality, regulatory, project management, manufacturing, engineering, or marketing research) * Experience working directly with ISO, FDA ...
Manager, Human Factors (Cincinnati, OH, US, 45241)
Cincinnati, OH · On-site
$120 - $180/hr
... consultants * Experience in additional functional areas (e.g., quality, regulatory, project management, manufacturing, engineering, or marketing research) * Experience working directly with ISO, FDA ...
Clinical Research Coordinator
$23.25 - $31/hr
Coordinates and manages all components required for an organized multi-disciplinary team approach ... Functioning as an educator, consultant/liaison, and evaluator, the Clinical Research Coordinator ...
Clinical Research Coordinator
$23.25 - $31/hr
Coordinates and manages all components required for an organized multi-disciplinary team approach ... Functioning as an educator, consultant/liaison, and evaluator, the Clinical Research Coordinator ...
Clinical Research Coordinator
Cincinnati, OH · On-site
$23.25 - $31/hr
... functioning as an educator, consultant, and liaison while collaborating closely with ... Coordinates and manages all components required for an organized multi-disciplinary team approach ...
Clinical Research Coordinator
Cincinnati, OH · On-site
$23.25 - $31/hr
... functioning as an educator, consultant, and liaison while collaborating closely with ... Coordinates and manages all components required for an organized multi-disciplinary team approach ...
Engineering Design Manager
Mason, OH · On-site
This is a senior-level consulting and technical leadership role for a recognized engineering expert ... Demonstrated expertise in FDA-regulated product development processes and Design Controls.
Quick apply
Engineering Design Manager
Mason, OH · On-site
This is a senior-level consulting and technical leadership role for a recognized engineering expert ... Demonstrated expertise in FDA-regulated product development processes and Design Controls.
Clinical Research Coordinator
Cincinnati, OH · On-site
$23.25 - $31/hr
... functioning as an educator, consultant, and liaison while collaborating closely with ... Coordinates and manages all components required for an organized multi-disciplinary team approach ...
Clinical Research Coordinator
Cincinnati, OH · On-site
$23.25 - $31/hr
... functioning as an educator, consultant, and liaison while collaborating closely with ... Coordinates and manages all components required for an organized multi-disciplinary team approach ...
Clinical Research Coordinator
Cincinnati, OH · On-site
$23.25 - $31/hr
... functioning as an educator, consultant, and liaison while collaborating closely with ... Coordinates and manages all components required for an organized multi-disciplinary team approach ...
Clinical Research Coordinator
Cincinnati, OH · On-site
$23.25 - $31/hr
... functioning as an educator, consultant, and liaison while collaborating closely with ... Coordinates and manages all components required for an organized multi-disciplinary team approach ...
About the Company Stark Pharma Solutions Inc. is a global consulting and staffing partner ... Perform maintenance activities according to GMP, FDA, and site SOP requirements. * Document ...
Quick apply
About the Company Stark Pharma Solutions Inc. is a global consulting and staffing partner ... Perform maintenance activities according to GMP, FDA, and site SOP requirements. * Document ...
Medical Director
Hamilton, OH · On-site
Serve as the primary physician for FDA reporting; monitor center medical compliance with applicable ... Uphold cGMP standards through collaboration with center management and quality; maintain high ...
Quick apply
Medical Director
Hamilton, OH · On-site
Serve as the primary physician for FDA reporting; monitor center medical compliance with applicable ... Uphold cGMP standards through collaboration with center management and quality; maintain high ...
Serve as the primary physician for FDA reporting; monitor medical compliance per Title 21 CFR and ... Maintain cGMP adherence via collaboration with center management and quality; be onsite for agreed ...
Quick apply
Serve as the primary physician for FDA reporting; monitor medical compliance per Title 21 CFR and ... Maintain cGMP adherence via collaboration with center management and quality; be onsite for agreed ...
Validation Engineer
Columbus, OH · On-site
About the Company Stark Pharma Solutions Inc. is a global consulting and staffing partner ... Ensure validation activities comply with cGMP, FDA, and EMA requirements. * Support OSD ...
New
Quick apply
Validation Engineer
Columbus, OH · On-site
About the Company Stark Pharma Solutions Inc. is a global consulting and staffing partner ... Ensure validation activities comply with cGMP, FDA, and EMA requirements. * Support OSD ...
New
Lab Services Manager
Columbus, OH · On-site
... consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and ... The Lab Services Manager is responsible for the day-to-day management and operational oversight of ...
Quick apply
Lab Services Manager
Columbus, OH · On-site
... consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and ... The Lab Services Manager is responsible for the day-to-day management and operational oversight of ...
Lab Services Manager
Columbus, OH · On-site
... consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and ... The Lab Services Manager is responsible for the day-to-day management and operational oversight of ...
Lab Services Manager
Columbus, OH · On-site
... consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and ... The Lab Services Manager is responsible for the day-to-day management and operational oversight of ...
Senior Director of Regulatory Affairs
Cleveland, OH · On-site
$148K - $196K/yr
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred. * Experience supporting FDA inspections, audits, quality system activities, complaint ...
Quick apply
Senior Director of Regulatory Affairs
Cleveland, OH · On-site
$148K - $196K/yr
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred. * Experience supporting FDA inspections, audits, quality system activities, complaint ...
Senior Director of Regulatory Affairs
Cleveland, OH · On-site
$180 - $240/hr
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred. * Experience supporting FDA inspections, audits, quality system activities, complaint ...
Senior Director of Regulatory Affairs
Cleveland, OH · On-site
$180 - $240/hr
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred. * Experience supporting FDA inspections, audits, quality system activities, complaint ...
Senior Director of Regulatory Affairs
$125K - $225K/yr
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred. * Experience supporting FDA inspections, audits, quality system activities, complaint ...
Senior Director of Regulatory Affairs
$125K - $225K/yr
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred. * Experience supporting FDA inspections, audits, quality system activities, complaint ...
Senior Director of Regulatory Affairs
Cleveland, OH · On-site
$148K - $196K/yr
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred. * Experience supporting FDA inspections, audits, quality system activities, complaint ...
Senior Director of Regulatory Affairs
Cleveland, OH · On-site
$148K - $196K/yr
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred. * Experience supporting FDA inspections, audits, quality system activities, complaint ...
Senior Director of Regulatory Affairs
Cleveland, OH · On-site
$160 - $230/hr
Experience managing regulatory personnel, consultants, vendors, or cross‑functional submission teams preferred. * Experience supporting FDA inspections, audits, quality system activities, complaint ...
Senior Director of Regulatory Affairs
Cleveland, OH · On-site
$160 - $230/hr
Experience managing regulatory personnel, consultants, vendors, or cross‑functional submission teams preferred. * Experience supporting FDA inspections, audits, quality system activities, complaint ...
Senior Director of Regulatory Affairs
Cleveland, OH · On-site
$125 - $225/hr
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred. * Experience supporting FDA inspections, audits, quality system activities, complaint ...
Senior Director of Regulatory Affairs
Cleveland, OH · On-site
$125 - $225/hr
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred. * Experience supporting FDA inspections, audits, quality system activities, complaint ...
Manager Fda Consulting information
What does a manager in FDA consulting do?
How does a manager in FDA consulting typically collaborate with cross-functional teams to ensure regulatory compliance for clients?
What are the key skills and qualifications needed to thrive as a manager in FDA consulting, and why are they important?
What is the difference between Manager Fda Consulting vs Regulatory Affairs Specialist?
| Aspect | Manager Fda Consulting | Regulatory Affairs Specialist |
|---|---|---|
| Credentials | Typically requires a bachelor's or master's in life sciences, with experience in FDA regulations | Usually holds a bachelor's degree in life sciences or related field, with certification preferred |
| Work Environment | Consulting firms, client sites, or remote; project-based work | In-house or pharmaceutical/medical device companies; regulatory departments |
| Industry Usage | Commonly employed in consulting firms advising multiple clients | Primarily employed within companies managing regulatory submissions |
While both roles require knowledge of FDA regulations, a Manager Fda Consulting typically leads consulting projects and advises clients, whereas a Regulatory Affairs Specialist manages regulatory submissions within a company. The roles differ mainly in scope, environment, and responsibilities, but share core regulatory knowledge.
What are popular job titles related to Manager Fda Consulting jobs in Ohio?
For Manager Fda Consulting jobs in Ohio, the most frequently searched job titles are:
What job categories do people searching Manager Fda Consulting jobs in Ohio look for?
The top searched job categories for Manager Fda Consulting jobs in Ohio are:
What cities in Ohio are hiring for Manager Fda Consulting jobs?
Cities in Ohio with the most Manager Fda Consulting job openings:

Oracle Fusion Manufacturing Senior Manager - Life Sciences & Pharmaceuticals
Hartford, OH • On-site
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
This job post has expired 1 day ago. Applications are no longer accepted.
Accenture Federal Services rating
8.7
Based on 20 frontline employees who took The Breakroom Quiz
51st of 500 rated business services
Job description
We Are:
Accenture's Oracle practice, and we make the new happen now. Every day, we imagine the future and bring it to life using design thinking, agile development methodologies, and new smart tech like IoT, automation, and AI. We even built our own platform, myConcerto, that mixes the best parts of Accenture and Oracle to help companies come into their own as digital leaders. Ready to find genius answers to seriously hard business challenges and work with some of the best Come join a team that feels personal even though it's over 54,000 strong. As a Global Cloud Elite and Platinum member of the Oracle Partner Network with over 145 awards, we're proud the industry is taking notice of our work, too. Visit us here to find out more about Accenture's Oracle practice:
The Work
We are seeking an experienced Oracle Fusion Manufacturing Senior Manager to lead large-scale business transformation and ERP implementation programs within the Life Sciences and Pharmaceutical industry. This role focuses on helping clients modernize manufacturing operations through Oracle Fusion Cloud Manufacturing and Supply Chain solutions while ensuring compliance with industry regulations including FDA, GMP, GxP, and global quality standards.
The successful candidate will combine deep Oracle Fusion Manufacturing expertise with pharmaceutical industry knowledge to lead strategy, solution design, implementation, and optimization initiatives across manufacturing, quality, inventory, planning, costing, and supply chain functions.
As a Senior Manager, you will drive client engagement delivery, mentor consulting teams, support business development activities, and serve as a trusted advisor to executive stakeholders.
Key Responsibilities:
Client Leadership & Delivery:
Lead Oracle Fusion Manufacturing and SCM transformation programs from strategy through deployment and stabilization.
Serve as engagement lead for complex Oracle Cloud implementations within pharmaceutical, biotechnology, medical device, and life sciences organizations.
Develop target operating models aligned with business and regulatory requirements.
Advise executive stakeholders on manufacturing modernization, digital transformation, and supply chain optimization initiatives.
Manage project scope, budget, delivery risks, quality assurance, and stakeholder communications.
Lead workshops, solution design sessions, and executive steering committee meetings.
Oracle Fusion Manufacturing Leadership:Lead solution design and implementation across:
Manufacturing
Oracle Fusion Manufacturing
Work Definition Management
Work Execution
Production Scheduling
Product Structures and Bills of Material (BOM)
Supply Chain
Inventory Management
Procurement
Supply Planning
Demand Planning
Logistics and Warehouse Operations
Quality & Compliance
Oracle Fusion Quality Management
Lot and Serial Traceability
Material Status Controls
Electronic Records Support
Validation Documentation
Cost & Finance Integration
Manufacturing Cost Management
Standard and Actual Costing
Cost Rollups
Inventory Valuation
Integration with Oracle Fusion Financials
Life Sciences & Pharmaceutical Expertise
Lead clients through regulated manufacturing environments governed by:
FDA 21 CFR Part 11
cGMP
GxP
EMA Requirements
Global Validation Standards
Design compliant manufacturing and quality processes.
Support Computer System Validation (CSV) activities.
Define risk-based validation approaches.
Facilitate audit readiness and compliance assessments.
Improve batch production, inventory visibility, product traceability, and quality controls.
Business Development & Practice Growth
Lead proposal development, RFP responses, and client presentations.
Build executive-level relationships with pharmaceutical and life sciences clients.
Identify opportunities to expand Oracle Cloud transformation services.
Develop Oracle-related industry solutions, accelerators, and implementation methodologies.
Contribute to annual sales targets and practice revenue growth.
Team Leadership
Lead diverse teams of functional consultants, architects, and client stakeholders.
Coach managers, consultants, and analysts.
Support talent acquisition, performance management, and career development.
Foster a culture of innovation, collaboration, and continuous improvement.
Provide thought leadership across Oracle and industry communities.
Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements
Here's what you need:
Minimum of 8 years of Consulting and Industry experience.
Minimum of 7 years experience leading Oracle Manufacturing implementations.
Minimum of 5 years experience managing large consulting engagements, including leading multiple full lifecycle Oracle Fusion Cloud Manufacturing implementations.
Experience serving pharmaceutical, biotechnology, medical device, or life sciences clients.
Bachelor's Degree or equivalent (12 years) work experience (If an, Associate's Degree with 6 years of work experience)
Bonus Points if:
You have strong experience with:
Oracle Fusion Manufacturing
Oracle Inventory Management
Oracle Supply Planning
Oracle Procurement
Oracle Product Management
Oracle Quality Management
Oracle Cost Management
Oracle Order Management
Oracle Financials integration
You have demonstrated experience in the following industries:
Pharmaceutical manufacturing
Biotech operations
Clinical supply management
Batch manufacturing
Product traceability
Quality and compliance programs
Validation and CSV processes
Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below.
We anticipate this job posting will be posted until 10/06/2026.
Accenture offers a market competitive suite of benefits including medical, dental, vision, life, and long-term disability coverage, a 401(k) plan, bonus opportunities, paid holidays, and paid time off.
See more information on our benefits here: U.S. Employee Benefits | Accenture
Role Location Annual Salary Range
California $132,500 to $302,400
Cleveland $122,700 to $241,900
Colorado $132,500 to $261,300
District of Columbia $141,100 to $278,200
Illinois $122,700 to $261,300
Maine $112,900 to $222,500
Maryland $132,500 to $261,300
Massachusetts $132,500 to $278,200
Minnesota $132,500 to $261,300
New York $122,700 to $302,400
New Jersey $141,100 to $302,400
Virginia $122,700 to $278,200
Washington $141,100 to $278,200
About Accenture
Accenture is a leading global professional services company that helps the world's leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services-creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world's leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360 value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360 value we create for our clients, each other, our shareholders, partners and communities.Visit us atwww.accenture.com
What We Believe
We have an unwavering commitment to diversity with the aim that every one of our people has a full sense of belonging within our organization. As a business imperative, every person at Accenture has the responsibility to create and sustain an inclusive environment.
Inclusion and diversity are fundamental to our culture and core values. Our rich diversity makes us more innovative and more creative, which helps us better serve our clients and our communities.Read more here
Requesting An Accommodation
Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at 1 (877) 889-9009 or send us anemailor speak with your recruiter.
Equal Employment Opportunity Statement
We believe that no one should be discriminated against because of their differences.All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, military veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by applicable law.Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.
For details, view a copy of the Accenture Equal Opportunity Statement
Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities.
Accenture is committed to providing veteran employment opportunities to our service men and women.
Other Employment Statements
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Further, at Accenture a criminal conviction history is not an absolute bar to employment.
The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information.
California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los Angeles County upon being hired for this position, pleaseclick herefor additional important information.
Please read Accenture'sRecruiting and Hiring Statementfor more information on how we process your data during the Recruiting and Hiring process.
What Accenture Federal Services employees say
Pay
Benefits
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About Accenture Federal Services
Sourced by ZipRecruiter
Industry
It services
Company size
10,000+ Employees
Headquarters location
Arlington, VA, US
Year founded
1989