Principal Compliance Consultant (Former FDA ORA/OMQ Experience Preferred)

Parexel

Olympia, WA

Apply

JOB DETAILS

SKILLS

Active Pharmaceutical Ingredient (API), Asepsis, Biology, Business Administration, Business Development, Center For Drug Evaluation and Research (CDER), Communication Skills, Consulting, Cross-Functional, Customer Support/Service, Data Quality, Documentation, Dosage Forms, Drug Manufacturing, Drug Products, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), Leadership, Maintain Compliance, Manufacturing, Manufacturing Systems, Mentoring, Patient Safety, Problem Solving Skills, Process Improvement, Public Health, Quality Management, Regulations, Risk, Risk Analysis, Risk Management, Root Cause Analysis, Safety Compliance, Surveillance, Team Player, Willing to Travel

LOCATION

Olympia, WA

POSTED

28 days ago

An incredible opportunity to apply your FDA experience in a way that drives solutions and meaningful impact for clients. What if your next role allowed you to move beyond observations and actively shape outcomes, influencing compliance strategies and driving lasting improvement across the industry? At Parexel Consulting, former FDA professionals partner with industry to solve complex compliance challenges, guide strategy, and drive meaningful, lasting improvements across global life sciences organizations. Parexel Consulting is growing and we are seeking a Principal Consultant with prior FDA experience to join our Strategic Compliance team. This role is designed for senior professionals who have built deep expertise within the FDA and are now interested in applying that experience in a more proactive, solution-oriented environment. In contrast to a strictly enforcement-focused role, this position provides the opportunity to work directly with clients to identify risks early, solve complex regulatory challenges, and help organizations achieve and sustain compliance-ultimately impacting product quality and patient outcomes. This opportunity offers a unique transition from regulatory enforcement into strategic advisory work, where you will: + Move beyond identifying observations to helping clients prevent them + Apply your FDA experience to shape compliance strategies before inspections occur + Partner with organizations to resolve complex issues rather than only documenting them + Influence outcomes by guiding remediation, readiness, and long-term quality improvements + Work across a diverse set of companies, products, and global environments Key Responsibilities + Serve as a senior advisor to clients on FDA regulatory expectations, inspection strategy, and compliance risk mitigation + Lead inspection readiness and mock inspection programs, helping clients prepare with confidence + Apply firsthand FDA knowledge to anticipate inspection findings and proactively address gaps + Advise on and support response strategies for: + Form FDA 483 observations + Warning letters + Import alerts + Regulatory meetings + Consent decrees and enforcement actions + Guide clients through root cause analysis, remediation planning, and sustainable compliance solutions + Provide expertise in risk-based decision-making, including regulatory discretion and supply continuity + Collaborate across cross-functional teams to support complex quality and regulatory engagements + Mentor team members and contribute to building internal expertise + Engage in client discussions and contribute to business development efforts Experience Required + A proven track record of experience working at the FDA in the Office of Regulatory Affairs (ORA), Office of Inspections and Investigations (OII), and/or Office of Compliance (CDER) + Leadership in domestic and international GMP inspections, including foreign cadre assignments + Experience conducting for-cause, pre-approval, and surveillance inspections + Involvement in high-priority or complex inspections + Direct experience supporting regulatory enforcement actions, including: + Drafting or contributing to Warning Letters + Developing Import Alert recommendations + Participating in recalls, regulatory meetings, or enforcement escalations + Engagement with industry on compliance expectations and post-inspection follow-up Preferred Technical Expertise + Data Integrity inspections and remediation + Sterile manufacturing / aseptic processing + API and drug product manufacturing across multiple dosage forms Qualifications + Prior experience with the U.S. Food and Drug Administration in inspection, compliance, or enforcement roles + Demonstrated experience across the inspection and enforcement lifecycle + Strong understanding of GMP compliance and pharmaceutical manufacturing systems + Experience conducting inspections internationally or as part of a foreign inspection cadre + Ability to translate regulatory expectations into clear, actionable solutions for clients + Strong communication and stakeholder engagement skills + Ability to travel 50-70% with a focus on international travel Education & Experience Requirements + Bachelor's degree required (life sciences, engineering, public health, or related field) + Advanced degree preferred (e.g., MPH, MS, PhD, MBA) + 15+ years of related experience, including significant FDA experience in inspection, compliance, or enforcement roles What We Offer + Opportunity to move from enforcement to influence, helping organizations proactively meet regulatory expectations + Exposure to complex and high-impact challenges across global life sciences clients + Collaborative consulting environment with leadership and mentorship opportunities + The ability to directly contribute to improving product quality, compliance, and patient safety \#LI-LB1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

About the Company

Parexel

INDUSTRY

Other/Not Classified