Principal Compliance Consultant - Data Integrity exp is a plus

When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.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 themApply your FDA experience to shape compliance strategies before inspections occurPartner with organizations to resolve complex issues rather than only documenting themInfluence outcomes by guiding remediation, readiness, and long-term quality improvementsWork across a diverse set of companies, products, and global environmentsKey ResponsibilitiesServe as a senior advisor to clients on FDA regulatory expectations, inspection strategy, and compliance risk mitigationLead inspection readiness and mock inspection programs, helping clients prepare with confidenceApply firsthand FDA knowledge to anticipate inspection findings and proactively address gapsAdvise on and support response strategies for:Form FDA 483 observationsWarning lettersImport alertsRegulatory meetingsConsent decrees and enforcement actionsGuide clients through root cause analysis, remediation planning, and sustainable compliance solutionsProvide expertise in risk-based decision-making, including regulatory discretion and supply continuityCollaborate across cross-functional teams to support complex quality and regulatory engagementsMentor team members and contribute to building internal expertiseEngage in client discussions and contribute to business development effortsExperience RequiredA 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 assignmentsExperience conducting for-cause, pre-approval, and surveillance inspectionsInvolvement in high-priority or complex inspectionsDirect experience supporting regulatory enforcement actions, including:Drafting or contributing to Warning LettersDeveloping Import Alert recommendationsParticipating in recalls, regulatory meetings, or enforcement escalationsEngagement with industry on compliance expectations and post-inspection follow-upPreferred Technical ExpertiseData Integrity inspections and remediationSterile manufacturing / aseptic processingAPI and drug product manufacturing across multiple dosage formsQualificationsPrior experience with the U.S. Food and Drug Administration in inspection, compliance, or enforcement rolesDemonstrated experience across the inspection and enforcement lifecycleStrong understanding of GMP compliance and pharmaceutical manufacturing systemsExperience conducting inspections internationally or as part of a foreign inspection cadreAbility to translate regulatory expectations into clear, actionable solutions for clientsStrong communication and stakeholder engagement skillsAbility to travel 50-70% with a focus on international travelEducation & Experience RequirementsBachelor’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 rolesWhat We OfferOpportunity to move from enforcement to influence, helping organizations proactively meet regulatory expectationsExposure to complex and high-impact challenges across global life sciences clientsCollaborative consulting environment with leadership and mentorship opportunitiesThe ability to directly contribute to improving product quality, compliance, and patient safetyEEO DisclaimerParexel 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.Originally posted on Himalayas