Vice President, Quality & CMC Regulatory

Geron Corporation

7d•Remote

About The Position

The Vice President of Quality & CMC Regulatory provides strategic and operational leadership for the Company’s Quality organization, with direct oversight of Quality Assurance (QA), Quality Control (QC), and CMC Regulatory functions. The Vice President is accountable for establishing, maintaining, and advancing GxP-compliant quality systems that support the development, manufacturing, and commercialization of the Company’s products. The Vice President will guide the evolution of the Quality and CMC Regulatory infrastructure as programs progress ensuring compliance with applicable U.S., EU, and global regulatory requirements. This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The Vice President will report to the Senior Vice President and Chief Technical Officer.

Requirements

Ability to lead and effectively participate in cross-functional and multi-disciplinary teams
Must thrive in a team-oriented entrepreneurial environment
Strong understanding of US, EU and global regulations and guidance for pharmaceutical development, clinical trial conduct, and post-marketing commercial operations
Well-organized and detailed oriented with excellent verbal and written communication skills
Ability to successfully manage external partners
Highly diplomatic and tactful with exceptional critical reasoning skills
Ability to deal with ambiguity with a creative and pragmatic approach to problem solving
Strong leadership and management skills
Master’s or Ph. D in chemistry, pharmaceutical sciences, biochemistry or relevant science field;
Minimum of 15 years of pharmaceutical or biotechnology experience in all aspects of quality, particularly in the areas of QA and QC, and CMC regulatory
Proven experience in developing and managing quality functions and systems in an early-stage clinical trial and commercial stage environment
Demonstrated experience leading a QA function, including significant experience in an early stage (pre-IND to commercial) biotechnology company
Post-marketing QA experience in support of commercial operations
Track record of building, developing, and leading high-impact QA/QC teams

Responsibilities

Provide executive leadership for QA, QC, and CMC Regulatory functions across the organization
Establish and maintain GxP-compliant systems, policies, and controls supporting GLP, GMP, and GCP activities
Conduct quality gap assessments and develop, execute, and track remediation plans to ensure inspection readiness at all stages
Lead the strategic maturation of the Company’s Quality Management System (QMS) to support company’s early-stage development and commercialization of oncology therapies
Oversee management of document control system
Provide oversight of Quality-related activities for lot release, including lot file compliance review
Oversee the conduct of Out-of-Specification (OOS) results, deviations, and exceptions investigations, as necessary
Provide oversight of stability programs to support clinical, registration, and commercial requirements
Prepare the organization for and lead responses to regulatory inspections and audits, including pre-approval, BIMO, post-marketing, and routine health authority inspections
Serve on multi-disciplinary project teams as the Quality representative to provide advice on the compliant development of products
Define and execute CMC regulatory strategies; oversee the preparation, review, submission, and maintenance of regulatory filings (e.g., INDs, IMPDs, NDAs, BLAs, MAAs)

Benefits

All regular-status, full-time employees of Geron are eligible to participate in the Company’s comprehensive benefit program, pursuant to plan terms and conditions.
Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan.
Geron also provides regular-status, full-time employees with a generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events.
Geron recognizes that its employees work in many different states and therefore may be affected by different laws.
It is Geron’s intention to comply with all applicable federal, state, and local laws that apply to the Company’s employees.

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