Senior / Principal Regulatory Compliance Consultant

Parexel • Southport, NC

11d

About The Position

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. Work With Heart, Lead with Impact At 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 Exceptional This 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 Overview The 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.

Requirements

• 10+ years QC Microbiology experience, including supervisory or managerial responsibility
• Deep experience supporting aseptic manufacturing of sterile drug products
• Expertise in EM, CCS, APS, water systems, sterility assurance, and microbiology lab operations
• Strong 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 trending
• Excellent communication skills with the ability to influence and educate teams
• Ability to travel up to 70% domestically and internationally

Nice To Haves

• Prior consulting experience
• Experience with facility startup, remediation, or major operational readiness efforts
• ASQ CQA or similar certification
• Experience preparing for and supporting FDA/EMA regulatory inspections
• Strong experience authoring technical or regulatory documentation

Responsibilities

• Serve as a trusted expert in: QC Microbiology operations and laboratory leadership Aseptic processing and sterile drug manufacturing Contamination Control Strategies (CCS) Environmental Monitoring (EM) programs Microbial identification, trending, investigations, and CAPA oversight Water systems, cleaning/disinfection, and sterility assurance
• Lead high-impact projects, including: Designing or optimizing EM, APS, AOQ, and CCS programs Supporting facility expansions, lab startups, and method qualifications Conducting regulatory readiness assessments and mock inspections Authoring and reviewing SOPs, risk assessments (HACCP, FMEA), validation protocols, and technical documentation Leading investigations using root cause analysis principles
• Partner with client leadership to: Strengthen quality systems aligned with FDA, EMA, ICH, USP, and global standards Coach microbiology and manufacturing teams on aseptic best practices Drive compliance improvements that enhance operational reliability and inspection outcomes Build sustainable, risk-based programs that reduce deviations and contamination events
• You will be the person clients turn to when they need expert guidance, clear solutions, and leadership under pressure.

Benefits

• A meaningful mission—improving patient safety across global manufacturing sites
• High-impact work with major biopharma and sterile drug product companies
• A culture of support, collaboration, and empathy—true to our “With Heart” value
• Consulting development and mentorship, including structured support for those new to consulting
• Flexibility—remote work when not on client site, plus variety in daily responsibilities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed