Responsibilities:
- Provide quality oversight of global supply chain operations supporting early and late-stage clinical programs.
- Ensure quality requirements are incorporated into procurement, manufacturing, packaging, storage, transportation, and distribution.
- Oversee quality aspects of warehousing and distribution operations.
- Qualify, monitor, and maintain approval status of suppliers, CMOs, laboratories, depots, and logistics providers.
- Participate in supplier audits and quality risk assessments.
- Manage supplier quality agreements and ensure periodic review.
- Ensure compliance with Good Distribution Practices.
- Oversee qualification of shipping lanes and transportation providers; review shipping validation documentation.
- Assess quality impact of shipping deviations (including temperature excursion investigations and product impact assessments).
- Identify continuous improvement opportunities while maintaining compliance.
- Maintain current knowledge of evolving regulatory expectations; translate into practical operational guidance.
Required Qualifications:
- Bachelorβs degree in chemistry, pharmaceutical sciences, life sciences, engineering, or related.
- 5+ years in supply chain or supply chain quality assurance in pharma/biopharma with global distribution.
- Experience directing outsourced manufacturing, testing, packaging/labeling, and distribution operations.
- Thorough knowledge of FDA 21 CFR Parts 210/211; ICH (Q7, Q8, Q9, Q10, Q11); EudraLex Volume 4 GMP; practical application to CMC.
- Proven track record managing quality events, deviations, CAPA, and change control.
- Experience supporting regulatory agency inspections (FDA, EMA, or equivalent).
- Excellent project management; ability to manage multiple high-priority deliverables.
- Strong verbal and written communication skills.
- Ability to travel domestically and internationally to CDMO and laboratory sites.
Preferred Qualifications:
- Experience scaling quality operations in a clinical-stage biotech environment toward commercialization.
- Experience with electronic QMS platforms (e.g., Veeva Vault) and document management.
- Expertise in development-phase and pre-commercial-phase quality assurance.