Director/Sr. Director, Quality Assurance Operations

Genezen•Lexington, MA

About The Position

Genezen provides process development, GMP viral vector production, and cell transduction 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. This includes quality oversight of GMP functions such as Facilities, Engineering, Validation, Manufacturing, Quality Control Laboratories, Supply Chain, Packaging and Labeling, Distribution, and external suppliers. The role builds and motivates a high-performing, innovative Quality Assurance organization that supports a culture of compliance, trust, accountability, efficient execution, collaboration, integrity, and respect. The Director supports the delivery of gene therapy medicines and works with operational teams and clients to maintain quality and regulatory compliance. The work schedule may change based on business needs, and a criminal background check is required.

Requirements

10+ years of relevant GMP experience in the pharmaceutical or biotech industry in a Quality role.
Experience working in a cGMP manufacturing environment.
Knowledge of cGMP, ICH, FDA, and EU regulations and guidelines.
Proficiency with Microsoft applications, including Outlook, Teams, Word, Excel, and PowerPoint.
Strong written and verbal communication skills for interacting with cross-functional teams.
Strong organizational skills and a high level of attention to detail.
Good problem-solving skills.
Ability to work with minimal supervision and work well with diverse groups.
Ability to multitask in a fast-paced environment with challenging timelines.
Adaptability to changes in work schedule based on business needs.
Ability to work in a BSL 2 environment with personal protective equipment and aseptic gowning, and around pharmaceutical facility machinery and utilities.
Ability to spend time on the floor during maintenance, construction, commissioning, and qualification activities.
Criminal background check required.

Nice To Haves

Bachelor’s degree and/or master’s degree in Life Sciences or Engineering.

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.
Guide operations on phase-appropriate cGMP requirements aligned with global regulations and internal Quality Management Systems.
Manage investigations and implement timely, effective corrective and preventive actions (CAPA).
Manage review and disposition of raw materials, intermediates, drug substance, and drug product, and ensure timely, 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 pre-approval inspections (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 capable of effectively executing its responsibilities.
Manage and maintain strong Quality-to-Quality relationships with clients.
Perform other duties as assigned.