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Manager Fda Consulting Jobs in Ohio (NOW HIRING)

cGMP Consulting

Packaging Engineer II

New Albany, OH · On-site

$75K - $95K/yr

About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and ... Manage multiple qualification activities while providing deliverable updates and modifications to ...

cGMP Consulting

Packaging Engineer II

New Albany, OH · On-site

$75K - $95K/yr

About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and ... Manage multiple qualification activities while providing deliverable updates and modifications to ...

cGMP Consulting

Senior Packaging Engineer

New Albany, OH · On-site

$85K - $100K/yr

Position Summary cGMP Consulting is seeking an experienced and driven individual to lead and manage ... of FDA regulations, and international compliance standards. Responsibilities The essential ...

Enable Injections

Manager, Human Factors

Cincinnati, OH · On-site

... consultants * Experience in additional functional areas (e.g., quality, regulatory, project management, manufacturing, engineering, or marketing research) * Experience working directly with ISO, FDA ...

Enable Injections

Manager, Human Factors

Cincinnati, OH · On-site

... consultants * Experience in additional functional areas (e.g., quality, regulatory, project management, manufacturing, engineering, or marketing research) * Experience working directly with ISO, FDA ...

TriHealth

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 ...

Ubertal Inc

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 ...

Certified Group

Lab Services Manager

Columbus, OH

... 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 ...

Certified Group

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 ...

Koscher & Würtz GmbH

$125.60 - $182.69/hr

FDA) und externe Auditoren * Planung, Durchführung und Nachbereitung von internen Audits ... Durchführung von Management-Reviews sowie Beratung und Unterstützung der Geschäftsleitung * ...

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All JobsFda Consulting JobsManager Fda Consulting JobsManager Fda Consulting Jobs in Ohio

Manager Fda Consulting information

What are the key skills and qualifications needed to thrive as a manager in FDA consulting, and why are they important?

To thrive as a Manager in FDA Consulting, you need a deep understanding of FDA regulations, compliance strategies, and industry best practices, typically supported by a relevant degree and experience in regulatory affairs. Familiarity with regulatory submission systems like eCTD, and certifications such as RAC (Regulatory Affairs Certification), are commonly required. Strong leadership, problem-solving abilities, and excellent communication skills set top performers apart in this role. These competencies ensure clients receive effective guidance through complex regulatory processes, minimizing compliance risks and expediting product approvals.

What does a manager in FDA consulting do?

A Manager in FDA consulting oversees projects and teams that help clients navigate the regulatory requirements set by the U.S. Food and Drug Administration (FDA). Their responsibilities include advising companies on compliance, preparing submissions, and developing strategies to obtain FDA approvals for products such as drugs, medical devices, and food items. They also ensure clients are up-to-date with changing regulations and help resolve any regulatory issues that may arise. This role requires strong project management skills, deep regulatory knowledge, and the ability to communicate complex requirements to clients.

What is the difference between Manager Fda Consulting vs Regulatory Affairs Specialist?

AspectManager Fda ConsultingRegulatory Affairs Specialist
CredentialsTypically requires a bachelor's or master's in life sciences, with experience in FDA regulationsUsually holds a bachelor's degree in life sciences or related field, with certification preferred
Work EnvironmentConsulting firms, client sites, or remote; project-based workIn-house or pharmaceutical/medical device companies; regulatory departments
Industry UsageCommonly employed in consulting firms advising multiple clientsPrimarily 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.

How does a manager in FDA consulting typically collaborate with cross-functional teams to ensure regulatory compliance for clients?

As a Manager in FDA Consulting, you'll frequently work alongside experts from regulatory affairs, quality assurance, clinical research, and product development to guide clients through complex compliance challenges. This often involves facilitating meetings, interpreting FDA guidelines, and coordinating the preparation of submission documents. Strong communication skills are essential, as you'll translate regulatory requirements into actionable strategies for diverse teams. Collaboration is key to ensuring all stakeholders are aligned and that client deliverables meet both regulatory and business objectives.
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:
Manager Fda Consulting jobs near you
Infographic showing various Manager Fda Consulting job openings in Ohio as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 84% Physical, 3% Hybrid, and 13% Remote job distribution.

Quality Assurance/ Data Integrity SME

Tunnell Consulting

Dayton, OH • On-site

Contractor

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.

Quality Assurance / Data Integrity SME

One of our clients is seeking a Quality Assurance/ Data Integrity SME to perform work predominantly onsite. This is a 6-9 month contract. Our client resides in the southwest corner of Ohio and is located in the greater Cincinnati-Wilmington-Maysville geographic area. Local candidates preferred.

Position Summary
The Quality Assurance (QA) / Data Integrity SME is responsible for ensuring compliance with GMP regulations, data integrity requirements, and company quality standards. This role supports audits, investigations, CAPAs, and regulatory inspections while serving as a subject matter expert on data integrity (paper and electronic based) and FDA 21 CFR Part 11 requirements.

Key Responsibilities

  • Ensure compliance with GMP, data integrity, and regulatory requirements.
  • Conduct and support internal, supplier, and regulatory audits.
  • Serve as an auditor or audit observer during inspections and assessments.
  • Investigate quality issues, deviations, and data integrity concerns.
  • Develop, present, and track Corrective and Preventive Actions (CAPAs) through closure.
  • Perform root cause analyses and recommend effective solutions.
  • Review electronic records and audit trails for compliance.
  • Support inspection readiness and regulatory interactions.
  • Provide training and guidance on quality systems and data integrity principles.
  • Prepare and deliver presentations on audit findings, CAPAs, and compliance activities.

Qualifications

  • Bachelor's degree in a scientific, technical, or related field.
  • 3+ years of Quality Assurance and Compliance in a regulated industry.
  • 1+ years of Data Integrity experience in a regulated industry.
  • Experience as an auditor and/or audit observer.
  • Proven experience leading investigations and CAPA resolution.
  • Strong presentation, communication, and problem-solving skills.

Required Knowledge

  • FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures).
  • Data Integrity principles (ALCOA/ALCOA+).
  • GMP regulations and Quality Management Systems (QMS).
  • CAPA, deviations, change controls, and risk assessments.
  • Audit trail review and computerized system compliance.

Preferred

  • ASQ Certified Quality Auditor (CQA) or similar certification.
  • Experience with systems such as TrackWise, Veeva, LIMS, Empower, SAP, or other validated GxP systems.
  • Experience supporting FDA or other regulatory inspections.

Ideal Candidate: A QA professional with strong auditing experience, data integrity expertise, knowledge of FDA 21 CFR Part 11, and a proven ability to lead investigations, present CAPAs, and drive compliance improvements.

Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.