Job Title

Work _With Heart_ , Lead with Impact At Parexel, _With Heart_ is more than a core valueu2014itu2019s how we approach every project, partnership, and patient impact. We bring deep scientific expertise together with empathy, integrity, and genuine human connection. Our consultants donu2019t just guide clients through compliance challenges; they become trusted partners helping sterile drug manufacturers deliver safe, effective therapies to people worldwide. If youu2019re 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 organizationsu2014 _with heart_ . Why This Role Is Exceptional This isnu2019t a traditional industry role. Itu2019s an opportunity to: + Amplify your influence by supporting multiple manufacturing sites and teams. + Accelerate your career through diverse, highu2011visibility consulting engagements. + Apply your microbiology and aseptic expertise where it matters most u2014on 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 problemu2011solving, and want to directly influence product quality and patient safety, youu2019ll 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 plusu2014not 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 + 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 u2014improving patient safety across global manufacturing sites + High-impact work with major biopharma and sterile drug product companies + A culture of support, collaboration, and empathy u2014true to our u201cWith Heartu201d value + Consulting development and mentorship , including structured support for those new to consulting + Flexibility u2014remote work when not on client site, plus variety in daily responsibilities Ready to Make a Global Impact? If youu2019re looking for a role where your microbiology expertise, leadership skills, and dedication to patient safety can truly change livesu2014and you want to do it _with heart_ u2014weu2019d love to review your application. Apply today and bring your expertise to clients around the worldu2014helping them make the sterile products patients rely on safer, one batch at a time. #LI-LB1 #LI-REMOTEEEO 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.