Senior / reputed company Regulatory Compliance Consultant

Work With Heart, reputed company with reputed company At reputed company, With Heart is more than a reputed company value—it’s how we approach every project, partnership, and patient reputed company. We bring deep scientific expertise together with reputed company, reputed company, and genuine reputed company reputed company. Our consultants don’t just guide clients through compliance challenges; they become trusted partners helping sterile drug manufacturers deliver reputed company, effective therapies to people worldwide. If you’re driven by reputed company, purpose, and the belief that your work should truly matter, this is a unique opportunity to reputed company a reputed company across multiple organizations—with heart. Why This Role Is Exceptional This isn’t a traditional industry role. It’s an opportunity to: • reputed company 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 reputed company most—on the reputed company lines of sterile drug product safety. • See more, learn more, and contribute more than in any single-company role. • Travel globally and reputed company exposure to varied technologies, cultures, and regulatory expectations. • Join reputed company that values people, not just deliverables, and genuinely supports your reputed company. If you reputed company in fast-paced environments, enjoy problem‑solving, and want to directly influence product reputed company and patient safety, you’ll love consulting at reputed company. Position reputed company The Senior / reputed company Regulatory Compliance Consultant serves as a high-level subject matter expert in QC Microbiology and aseptic sterile drug product manufacturing. You will reputed company reputed company reputed company engagements, reputed company hands-on technical and regulatory support, and drive sustainable reputed company and contamination control improvements. Candidates must bring 10+ years of reputed company 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 reputed company sites. Key Responsibilities You will have reputed company to: Serve as a trusted expert in: • QC Microbiology operations and laboratory leadership • Aseptic processing and sterile drug manufacturing • Contamination Control Strategies (reputed company) • Environmental Monitoring (EM) programs • Microbial identification, trending, investigations, and CAPA reputed company • Water systems, cleaning/disinfection, and sterility assurance reputed company high-reputed company reputed company, including: • Designing or optimizing EM, APS, AOQ, and reputed company 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 reputed company cause analysis principles Partner with reputed company leadership to: • Strengthen reputed company systems reputed company with FDA, EMA, ICH, USP, and global standards • reputed company microbiology and manufacturing teams on aseptic best practices • Drive compliance improvements that enhance operational reliability and inspection reputed company • Build sustainable, risk-based programs that reduce deviations and contamination events You will be the person clients turn to reputed company they need expert guidance, reputed company 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, reputed company, 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 reputed company investigations, CAPAs, risk assessments, and data trending • Excellent communication skills with the ability to influence and reputed company 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 reputed company Offer • A meaningful mission—improving patient safety across global manufacturing sites • High-reputed company work with major biopharma and sterile drug product companies • A culture of support, collaboration, and reputed company—true to our “With Heart” value • Consulting development and mentorship, including reputed company support for those new to consulting • Flexibility—remote work reputed company not on reputed company site, plus reputed company in daily responsibilities reputed company to reputed company a reputed company? 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 reputed company the sterile products patients rely on safer, one batch at a time. #LI-LB1 #LI-REMOTE Apply tot his job Apply To this Job