Director, Manufacturing Quality Assurance

Position Summary

The Director, Manufacturing Quality Assurance will be responsible for performing Quality Assurance (QA) oversight of Current Good Manufacturing Practices (cGMP) for the Company. The Director will report to the Senior Director, Quality.

This position is remote with a corporate headquarters in Foster City, CA & Parsippany, NJ. 

Primary Responsibilities 

• Oversee team of Manufacturing Quality Assurance (MQA) specialists and managers
• Coordinate the review of executed batch manufacturing and packaging records, associated documentation for compliance with cGMPs, and consistency with other Company policies and procedures
• Coordinate batch release with CMC team to ensure efficient and on-time release of products
• Record quality data metrics, including batch record receipt, and review and release information
• Assist in the development and review of Company SOPs, batch records, specifications, test methods, and validation documentation for compliance with cGMPs and consistency with other Company policies and procedures
• Provide batch related updates to the CMC team regarding pending releases and potential delays
• Assist with the audits of GMP vendors
• Perform other duties as assigned

Competencies 

• Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines, and other local government regulatory requirements governing clinical and commercial manufacturing
• Extensive knowledge and application of ALCOA+ standard, GMP, Good Documentation Practice, and International Council for Harmonization guidelines
• Ability to lead and effectively participate in cross-functional and multi-disciplinary teams and independently prioritize work, manage multiple projects while maintaining quality, and be an advocate for quality risk management and regulatory compliance
• Highly diplomatic and tactful individual with exceptional critical reasoning skills
• Ability to use expertise and skills to contribute to the development of Company objectives and principles and to achieve goals in creative and effective ways
• Ability to deal with ambiguity with a creative and pragmatic approach to problem solving
• Strong leadership and management skills
• Well-organized and detailed oriented professional with excellent verbal and written communication skills

Experience

• Bachelor’s degree in science/medical research or relevant field; Master’s degree a plus
• A minimum of 9 years of experience in pharmaceutical/biotechnology industries in clinical and GMP compliance
• Demonstrated experience in an early stage (pre-IND to Commercial) biotechnology company
• Direct experience with health authority inspections
• ASQ Auditor certifications a plus

Benefit Statement:

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.

Salary Statement:

Offered compensation is determined based on market data, internal equity, and an applicant’s relevant skills, experience, and educational background.  The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed.  Please note the employment opportunity is not limited to these locations. 

General Salary Range: $195,000 to $215,000