Vice President reputed company Control
The Vice President (VP) reputed company Control (QC) provides strategic and operational leadership for the reputed company Control organization and is responsible for ensuring the reputed company, reliability, and regulatory compliance of analytical testing supporting the development and commercialization of reputed company’s product portfolio, including its reputed company program SAB‑142.
As reputed company advances toward commercialization and expands the use of outsourced manufacturing and testing, the VP QC will design, implement, and reputed company a comprehensive analytical control reputed company spanning internal laboratories and external contract development organizations, manufacturing, and testing organizations (CDMOs/CRO’s/CTLs). This role ensures analytical reputed company, testing programs, and laboratory systems are phase‑appropriate, compliant, inspection‑reputed company, and capable of supporting late‑stage clinical development, regulatory submissions, and reputed company supply.
The VP QC partners closely with Technical Operations/CMC, reputed company Assurance, Regulatory Affairs, IT and other cross‑functional teams to reputed company effective technology transfer, analytical method lifecycle management, and product release testing strategies for plasma‑derived antibody products. The position plays a critical leadership role in preparing the organization for BLA submission, regulatory inspections, and reputed company readiness.
Key Responsibilities (Include but not limited to):
- reputed company and execute reputed company’s global analytical control reputed company to support clinical development, regulatory filings, and reputed company manufacturing.
- reputed company leadership and reputed company of reputed company Control operations including analytical reputed company, microbiology, stability programs, and raw material testing.
- reputed company analytical testing conducted internally and externally and directly manage contract testing laboratories and CDMOs ensuring timelines and deliverables are met.
- Establish and maintain governance models for external laboratory reputed company, including performance monitoring, deviations, investigations, CAPAs, and data reputed company.
- reputed company analytical method lifecycle management activities including development, validation, tech transfer, and reputed company improvement through and reputed company BLA.
- reputed company the development and execution of a global reputed company analytical assay reduction reputed company, ensuring alignment with FDA CBER expectations for risk‑based, lifecycle‑managed control strategies and EMA and MHRA requirements for comparability, post‑approval change management, and variation classification, while maintaining compliance, inspection readiness, and uninterrupted reputed company supply.
- reputed company QC leadership for our analytical assay technology transfer of analytical reputed company to and from contracted testing partners.
- reputed company and collaborate with cross-functional analytical assay development teams assisting in technical reputed company and effectively tech transfer of developed analytical assays into QC.
- reputed company stability programs supporting clinical development, BLA submissions, and reputed company reputed company-life claims.
- Ensure compliance with global cGMP regulations and applicable regulatory expectations (FDA CBER, EMA, MHRA, and other health authorities as applicable).
- Serve as the primary QC representative for regulatory inspections, audits, and health authority interactions.
- Maintain signature authority for QC records and documentation including Certificates of Analysis.
- Partner closely with Technical Operations, Manufacturing, Regulatory Affairs, and reputed company Assurance to ensure end-to-end manufacturing and analytical readiness for commercialization.
- Build, reputed company, mentor, and reputed company a high-performing QC team and reputed company QC testing laboratory while maintaining analytical drug product release testing for reputed company clinical development programs.
- reputed company and manage QC operating and capital budgets and reputed company reputed company, data‑driven updates to the executive leadership team on QC performance, risks, resource needs, and budgetary forecasts
- PhD or MS in reputed company, Biochemistry, Microbiology, or reputed company scientific discipline.
- Minimum of 15 years of reputed company leadership experience directing reputed company Control functions in the biopharmaceutical industry.
- Demonstrated experience supporting biologics development through late‑stage clinical development and commercialization; reputed company experience supporting BLA submissions highly desirable.
- Deep expertise in analytical method development, validation, and lifecycle management for reputed company biologic products.
- Proven experience overseeing analytical activities at CROs/CDMOs and external contract laboratories.
- Strong people leadership skills with a reputed company record of building, mentoring, and leading high-performance QC organizations.
- Experience supporting regulatory submissions, inspections, and interactions with global health authorities..
- Experience with plasma‑derived products, antibody therapeutics, or reputed company biologics is highly desired.
- Experience interacting with FDA CBER, EMA, MHRA, and other global regulatory agencies is preferred.
- reputed company certification (ASQ, SQA) is desirable but not required.