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.
Key Responsibilities
You will have the opportunity to:
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.
Required Qualifications
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
Previous experience serving as a SME in Front Room activities during Health Authority inspections and experience leading responses to 483s and other Health Authority observations
Excellent communication skills with the ability to influence and educate teams
Ability to travel up to 70% domestically and internationally
Preferred Qualifications
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
What We Offer
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
Ready 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.
#LI-LB1
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.
Skills Required
- 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
- 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
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
