Senior / Principal Regulatory Compliance Consultant

WorkWith Heart, Lead with ImpactAt Parexel, With Heart is more than a core value—it's how we approach every project, partnership, and patient impact. We bring deep scientific expertise together with empathy, integrity, and genuine human connection. Our consultants don't just guide clients through compliance challenges; they become trusted partners helping sterile drug manufacturers deliver safe, effective therapies to people worldwide.If you're driven by quality, purpose, and the belief that your work should truly matter, this is a unique opportunity to make a global impact across multiple organizations— with heart.Why This Role Is ExceptionalThis isn't a traditional industry role. It's an opportunity to:Amplify your influence by supporting multiple manufacturing sites and teams.Accelerate your career through diverse, high-visibility consulting engagements.Apply your microbiology and aseptic expertise where it matters most —on the front lines of sterile drug product safety.See more, learn more, and contribute more than in any single-company role.Travel globally and gain exposure to varied technologies, cultures, and regulatory expectations.Join a team that values people, not just deliverables, and genuinely supports your growth.If you thrive in fast-paced environments, enjoy problem-solving, and want to directly influence product quality and patient safety, you'll love consulting at Parexel.Position OverviewThe Senior / Principal Regulatory Compliance Consultant serves as a high-level subject matter expert in QC Microbiology and aseptic sterile drug product manufacturing. You will lead complex client engagements, provide hands-on technical and regulatory support, and drive sustainable quality and contamination control improvements.Candidates must bring 10+ years of progressive QC Microbiology supervisory or management experience in a sterile drug product environment. Prior consulting experience is a plus—not a requirement. We are excellent at transforming seasoned industry leaders into outstanding consultants.This role requires up to 70% domestic and international travel to support client sites.Key ResponsibilitiesYou will have the opportunity to:Serve as a trusted expert in:QC Microbiology operations and laboratory leadershipAseptic processing and sterile drug manufacturingContamination Control Strategies (CCS)Environmental Monitoring (EM) programsMicrobial identification, trending, investigations, and CAPA oversightWater systems, cleaning/disinfection, and sterility assuranceLead high-impact projects, including:Designing or optimizing EM, APS, AOQ, and CCS programsSupporting facility expansions, lab startups, and method qualificationsConducting regulatory readiness assessments and mock inspectionsAuthoring and reviewing SOPs, risk assessments (HACCP, FMEA), validation protocols, and technical documentationLeading investigations using root cause analysis principlesPartner with client leadership to:Strengthen quality systems aligned with FDA, EMA, ICH, USP, and global standardsCoach microbiology and manufacturing teams on aseptic best practicesDrive compliance improvements that enhance operational reliability and inspection outcomesBuild sustainable, risk-based programs that reduce deviations and contamination eventsYou will be the person clients turn to when they need expert guidance, clear solutions, and leadership under pressure.Required Qualifications10+ years QC Microbiology experience, including supervisory or managerial responsibilityDeep experience supporting aseptic manufacturing of sterile drug productsExpertise in EM, CCS, APS, water systems, sterility assurance, and microbiology lab operationsStrong working knowledge of global regulations (FDA 21 CFR 210/211, EMA Annex 1, ICH, USP)Proven ability to lead investigations, CAPAs, risk assessments, and data trendingExcellent communication skills with the ability to influence and educate teamsAbility to travel up to 70% domestically and internationallyPreferred QualificationsPrior consulting experienceExperience with facility startup, remediation, or major operational readiness effortsASQ CQA or similar certificationExperience preparing for and supporting FDA/EMA regulatory inspectionsStrong experience authoring technical or regulatory documentationWhat We OfferA meaningful mission —improving patient safety across global manufacturing sitesHigh-impact work with major biopharma and sterile drug product companiesA culture of support, collaboration, and empathy —true to our "With Heart" valueConsulting development and mentorship, including structured support for those new to consultingFlexibility —remote work when not on client site, plus variety in daily responsibilitiesReady to Make a Global Impact?If you're looking for a role where your microbiology expertise, leadership skills, and dedication to patient safety can truly change lives—and you want to do it with heart —we'd love to review your application.Apply today and bring your expertise to clients around the world—helping them make the sterile products patients rely on safer, one batch at a time.EEO 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.J-18808-Ljbffr