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Fda Consulting Jobs in Indiana (NOW HIRING)

CAI

Operational Readiness Project Manager

Indianapolis, IN · On-site

$140K - $175K/yr

We provide program and project management, commissioning, qualification, validation, start-up, and other consulting services associated with operational readiness and operational excellence to FDA ...

Inotiv

Study Director III, Toxicology

Mount Vernon, IN · On-site

In consultation with senior staff, prepare reports, papers and/or charts of study data for interim reports to the sponsor * Maintain knowledge of FDA and other regulatory guidelines that may affect ...

Inotiv

Study Director III, Toxicology

Mount Vernon, IN · On-site

In consultation with senior staff, prepare reports, papers and/or charts of study data for interim reports to the sponsor * Maintain knowledge of FDA and other regulatory guidelines that may affect ...

CAI

CQV Senior Project Manager

Indianapolis, IN · On-site

$120K - $175K/yr

We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical ...

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How much do fda consulting jobs pay per hour?

As of Jul 13, 2026, the average hourly pay for fda consulting in Indiana is $49.97, according to ZipRecruiter salary data. Most workers in this role earn between $20.82 and $66.35 per hour, depending on experience, location, and employer.

What is an FDA Consulting job?

An FDA Consulting job involves providing expert guidance to businesses seeking regulatory approval for their products from the U.S. Food and Drug Administration (FDA). Consultants help companies navigate complex FDA regulations, ensure compliance, and prepare necessary documentation for submissions. They may work with pharmaceuticals, medical devices, food, and biotech industries. Their role includes strategy development, risk assessment, and communication with the FDA to facilitate approvals and avoid compliance issues.

What are the key skills and qualifications needed to thrive in the Fda Consulting position, and why are they important?

To thrive in FDA Consulting, you need expertise in regulatory affairs, a deep understanding of FDA guidelines, and often a degree in life sciences or a related field. Familiarity with regulatory submission systems such as eCTD, knowledge of GxP standards, and certifications like RAC (Regulatory Affairs Certification) are valuable. Strong communication, analytical thinking, and project management skills set outstanding consultants apart. These competencies are essential to effectively guide clients through complex regulatory landscapes and ensure successful product approvals.

What does a typical day look like for an FDA Consultant?

As an FDA Consultant, your day might involve reviewing regulatory documentation, preparing submissions for FDA approval, and advising clients on compliance strategies. You’ll often attend meetings with cross-functional teams including R&D, quality assurance, and legal experts to ensure alignment on regulatory requirements. Consultants also stay updated on changes in FDA guidelines, draft correspondence to regulatory agencies, and address client questions or concerns. This dynamic role requires adaptability and strong collaboration skills to manage multiple projects and effectively support clients through all stages of the regulatory process.

What are the most commonly searched types of Fda Consulting jobs in Indiana? The most popular types of Fda Consulting jobs in Indiana are:
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Fda Consulting jobs near you
Infographic showing various Fda Consulting job openings in Indiana as of July 2026, with employment types broken down into 89% Full Time, 9% Part Time, and 2% Contract. Highlights an 83% Physical, 4% Hybrid, and 13% Remote job distribution, with an average salary of $103,936 per year, or $50 per hour.
Operational Readiness Project Manager

Operational Readiness Project Manager

CAI

Indianapolis, IN • On-site

$140K - $175K/yr

Full-time

Re-posted 7 hours ago

Job description

CAI Overview:
Are You Ready?
CAI is a professional services company established in 1996 that has grown to over 700 people worldwide. We provide program and project management, commissioning, qualification, validation, start-up, and other consulting services associated with operational readiness and operational excellence to FDA-regulated and other mission-critical industries.
We put our clients’ interests first, we do not stop until it is right, and we will do whatever it takes to get there.
At CAI, we are committed to living our Foundational Principles:
We act with integrity
We serve each other
We serve society
We work for our future
We believe that with employee ownership, one person’s success is everyone’s success. We embrace a Team Before Self mindset, demonstrate Respect for Others, and maintain a Can-Do Attitude—our three core values.
 
Position Overview:
The Operational Readiness Project Manager (ORPM) serves as a strategic leader bridging the gap between mechanical completion and sustained operational performance. The ORPM designs and leads holistic Operational Readiness programs using CAI’s six-pillar Readiness Framework. This role ensures project teams achieve right-first-time metrics, foster a culture of continuous improvement, and deliver world-class performance from day one.
 
Key Responsibilities:
1. Project & Program Leadership
- Lead project teams to achieve Operational Readiness (OR) objectives.
- Manage readiness-to-operations lifecycle for 1–3 client engagements simultaneously.
- Drive on-time, on-scope delivery of readiness programs.
 
2. Pillar Integration & Execution
- Serve as the primary consultant for OR campaigns integrating with Quality, Process, and Workforce streams.
- Apply OE principles to pre-Day One activities (e.g., visual management, accountability, problem-solving).
 
3. Client Advisory
- Act as a trusted advisor to executive stakeholders (VPs, Site Heads, etc.).
- Guide decision-making with a risk-based, speed-to-value mindset.
 
4. People Development
- Lead and coach cross-functional teams including CQV, Quality, and external contractors.
- Cultivate a culture of feedback and growth.
 
5. Thought Leadership
-Contribute to CAI's brand via white papers, conference presentations, and client tools.
 
Skills & Characteristics Required:
- Consulting & Facilitation
- Align project stakeholders with clear vision and measurable goals.
- Expert-level guidance for site and department leadership.
- Project Execution
- Manage scheduling, resource loading, controls, and closeout.
- Execute comprehensive project planning and delivery.
- Continuous Improvement
- Drive site-wide transformation using Lean, Six Sigma, or TPM methodologies.
 
Qualifications and Experience:
- BS or MS in a relevant science or engineering field (or equivalent).
- 3+ years as a program/project manager on life science projects ($1MM+), or
- 8+ years in GMP-regulated operations with 5+ years leading readiness/start-up/OE transformations.
(Black Belt or equivalent preferred.)
- Proven multi-site or multi-client portfolio experience.
- Deep understanding of quality systems, tech transfer, equipment qualification, and analytics.
- Excellent communication, leadership, and stakeholder management skills.
- Proficient in project management software tools.
 
Other Requirements:
- Excellent written and verbal English communication.
- Able to work in the U.S. without sponsorship now or in the future.
- Domestic and international travel may be required.
- Willing to work overtime when necessary.
- PMI PMP or PgMP certification a plus.
 
Critical Competencies
Influence Strategy
- Evaluates and pursues initiatives, opportunities, and priorities based on fit with organization strategies.
- Identifies innovative solutions to challenges that have strategic impact, balancing both short- and long-term concerns.
- Identifies issues related to emerging customer and market needs.
 
Satisfy the Customer
- Identifies and anticipates customer requirements, expectations, and needs.
- Develops solutions that meet or exceed customer expectations and shares feedback with relevant groups.
- Consistently follows up with customers to resolve issues and maintain customer satisfaction and loyalty.
- Continually searches for ways to improve customer service, including removal of barriers and providing solutions.
 
Plan for Success
- Translates business/function strategies into aligned plans and objectives and integrates across business groups.
- Obtains and allocates resources needed to accomplish goals.
- Anticipates risk and builds effective contingency plans.
 
Pursue Execution
- Prioritizes and balances time, actions, resources, and initiatives to ensure achievement of critical goals.
- Holds self and others accountable for achieving outcomes. 
- Anticipates obstacles and takes appropriate actions to accelerate work or improve quality.
 
Tailor Communication
- Communicates information clearly, concisely, and professionally.
- Tailors communication style and content to audience effectively.
- Writes technical concepts clearly and thoroughly for all audience types.
 
Build Partnerships
- Cultivates a network of people across a variety of disciplines and functions within the organization.
- Builds collaboration by identifying and conveying common interests and priorities, removing barriers, and breaking down silos.
- Appropriately involves others in decisions and plans that affect them.
- Maintains positive relationships regardless of challenges, organizational level, personality, or background differences.
 
Influence Others
- Develops and articulates compelling rationale for positions.
- Builds a broad base of support among key decision makers and influencers.
- Positions and explains ideas and proposals in ways that get support from others.
·  Encourages others to find new solutions that improve outcomes and deliver value.
 
Develop Self and Others
- Continuously develops interpersonal skills to build effective internal and external relationships.
·  Models company values and always acts with integrity.
·  Looks for opportunities to develop breakthrough ideas and initiatives.
Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.
 
CAI Benefits:
•Comprehensive Health Insurance coverage
•24 days of Paid Time Off
•Company paid Life Insurance
•Company paid Long Term Disability
We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.
 
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). 

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.