Director/Sr. Director, Quality Assurance Operations
About The Position
Genezen provides process development, GMP viral vector production, and cell transduction services for gene and cell therapy clinical trials. The Director of Quality Assurance is responsible for oversight of all elements of the Quality Management System (QMS), ensuring processes comply with global cGMP regulations. The role provides quality oversight across GMP functions, including Facilities, Engineering, Validation, Manufacturing, Quality Control Laboratories, Supply Chain, Packaging and Labeling, Distribution, and external Suppliers. The Director is responsible for building and motivating a high-performing, innovative Quality Assurance organization that fosters compliance, trust, accountability, efficient execution, collaboration, integrity, and respect in support of gene therapy medicines. The work schedule may change based on business needs. A criminal background check is required.
Requirements
- Experience working in a cGMP manufacturing environment.
- Well versed in cGMP, ICH, FDA, and EU regulations and guidelines.
- Proficient in Microsoft applications, including Outlook, Teams, Word, Excel, and PowerPoint.
- Strong written and verbal communication skills to interact with cross-functional teams.
- Strong organizational skills.
- High level of attention to detail.
- Good problem-solving skills.
- Capable of working with minimal supervision.
- Ability to work well with diverse groups.
- Ability to multitask in a fast-paced environment with challenging timelines.
- Adaptability, as the work schedule may change based on business needs.
- Must undergo a criminal background check.
Nice To Haves
- Bachelor’s degree and/or master’s degree in Life Sciences or Engineering.
- 10+ years of relevant GMP experience in the pharmaceutical or biotechnology industry in a Quality role.
Responsibilities
- Manage the development, implementation, maintenance, and improvement of relevant Quality Management Systems and processes to ensure compliance with global regulations and alignment with company strategy.
- Provide guidance to operations on phase-appropriate cGMP requirements aligned with global regulations and internal Quality Management Systems.
- Manage investigations and implement timely and effective CAPA.
- Manage review and disposition of raw materials, intermediates, drug substance, and drug product, and ensure timely and accurate completion of reported quality events.
- Provide Quality Assurance support to Manufacturing, MSAT, FEV, Quality Control, and Supply Chain.
- Develop, implement, and improve Quality System Metrics, and report performance trends and risks to senior management.
- Support a risk-based internal and external audit program.
- Host and support management of PAI and subsequent routine global health authority inspections.
- Assess the impact of new or updated regulations on the company’s Quality Management Systems and operations.
- Develop and maintain a high-performing Quality Assurance organization that effectively executes its responsibilities.
- Manage and maintain strong Quality-to-Quality relationships with clients.
Benefits
- Paid vacation days, with amount based on tenure.
- Paid sick time.
- 10 observed holidays, 2 floating holidays, and 1 volunteer day.
- 401(k) plan with company match up to 6% of salary.
- Share Appreciation Rights.
- Choice of several healthcare plans.
- FSA and HSA programs.
- Dental and vision care.
- Employer-paid basic term life and personal accident insurance.
- Voluntary disability and universal life/personal accident insurance.
- Accidental Death & Dismemberment (AD&D) insurance.
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What This Job Offers
Job Type
Full-time
Career Level
Director
