[Hiring] Principal Compliance Consultant @Parexel

Role Description

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. 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.

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

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

Requirements

• 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

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

Benefits

• 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

Company Description

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.