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Tier-1 employer and metro location increase applicant density, but senior, domain-specific requirements limit general applicants.
Role requires specialized biopharma manufacturing, regulatory, and CMC expertise, limiting cross-industry transferability.
Explicit 10+ years, advanced degree, and pharma regulatory expertise create strict mandatory filters.
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Lead and facilitate the Implementation Committee for assigned vaccines, managing global cross-functional teams across different geographies.
Oversee definition, tracking, and follow-up of market implementation strategies for regulatory impactful changes ensuring supply continuity and alignment with Product Life Cycle Management plans.
Provide GO/NO GO decisions for market implementation and monitor CMC envelopes throughout their lifecycle, escalating risks and issues with mitigation plans to governance bodies.
Advanced degree in process engineering sciences or life sciences (biology, biomedical science, pharmacy, chemistry, chemical engineering).
Minimum 10 years experience in biopharmaceutical manufacturing and/or QA, QC, R&D in a biological environment.
Proven project management experience and understanding of pharmaceutical regulatory compliance frameworks including change control processes and production/QC master data.
Familiarity with regulatory requirements in main regions (US/EU) and IT tools such as Excel, VeeVa, SAP.
Experienced in leading and managing global, cross-functional teams within matrix organizational structures across multiple geographies.
Strong background in coordinating regulatory change implementation aligning with product life cycle and supply needs in complex biopharma environments.
Skilled in project and change management with proven ability to communicate and negotiate across multiple cultural and functional boundaries.