Geron Corporation · 10 hours ago
Vice President, Quality & CMC Regulatory
United States
Full-time
Remote
Director/Executive
$310K/yr - $345K/yr
15+ years expGeron Corporation is seeking a Vice President of Quality & CMC Regulatory to provide strategic and operational leadership for their Quality organization. The role includes oversight of Quality Assurance, Quality Control, and CMC Regulatory functions, ensuring compliance with global regulatory requirements.
BiopharmaBiotechnologyHealth DiagnosticsOncologyPharmaceutical
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)
Qualification
Required
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
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
Benefits
Medical
Dental
Vision
Life insurance
Flexible spending accounts
Disability insurance
Supplemental health insurance
401(k) retirement savings plan
Employee stock purchase plan
Generous time off program
160 hours of vacation during each full year of employment
64 hours of sick leave
9 standard paid holiday days off
Paid leave for certain life events
Company
Geron Corporation
Geron is a biopharmaceutical company that is charting a new course with the goal to deliver innovative treatment options for people living with blood cancer.
201-500 employees
H1B Sponsorship
Geron Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$999.54MKey Investors
Pharmakon Advisors
2024-11-07Post Ipo Debt· $250M
2024-03-19Post Ipo Equity· $150M
2023-01-05Post Ipo Equity· $227.84M
Leadership Team
Harout Semerjian
President & CEO
Michelle Robertson
Chief Financial Officer
Recent News
New Enterprise Associates
2026-01-02
2025-12-19
2025-12-18
Company data provided by crunchbase