Director, Quality Assurance

Franklin Bio Lab•King of Prussia, PA

4h•Onsite

About The Position

Franklin Biolabs is seeking a Director, Quality Assurance to lead and oversee the Quality Assurance department. This role focuses on GMP analytical activities for clients, ensuring data integrity, regulatory compliance, and inspection readiness across multiple programs, sponsors, and testing platforms. The Director will ensure compliance with regulatory requirements, industry, and company standards. The position requires full-time on-site presence at the Discovery Labs location and may involve up to 15% domestic and/or international travel.

Requirements

Minimum of a BS required, advanced degree preferred in a scientific/technical discipline
10+ years of direct related experience in a CRO, biological and/or pharmaceutical industry with experience in cell and gene therapy.
5+ years of experience in a leadership or management role within the quality function.
Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.
Experience leading Quality Assurance oversight of GMP analytical activities.
Strong knowledge of Good Manufacturing Practice (GMP) requirements.
Knowledge of GLP, Good Clinical Laboratory Practice (GCLP) /Clinical Laboratory Improvement Amendments (CLIA)
Knowledge of regulatory compliance and agencies (USDA, OLAW, FDA, AAALAC) including animal care and use.
Demonstrated experience with writing/reviewing deviations, laboratory investigations, and OOS investigations. Expertise in root cause analysis.
Ability to apply regulations and international guidelines to all aspects of the position
Ability to write reports, business correspondence, and procedure manuals.
Track record of successfully leading Quality and compliance initiatives in a regulated environment.
Able to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to effectively present information to employees, management, executive leadership, public groups, and/or boards of directors.
Leadership and people management skills, with the ability to inspire and develop a high performing team.
Ability to assess and utilize software and custom programs to meet QA and organizational needs.
Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and all levels of the organization.
Ability to translate business objectives into actionable Quality strategies and initiatives.
Ability to travel domestically and/or internationally up to 15% of the time, depending on the needs of the project, the client and the company.
Ability to accommodate evening, overnight or weekend travel, including potential extended trips to attend training, meetings, conduct fieldwork, or meet with clients.
This position requires full-time on-site presence at our Discovery Labs location.
This position requires access to lab and lab animal spaces
Ability to distinguish between different colors (normal color vision).
Ability to see clearly at various distances.
Adequate near vision for reading documents or lab equipment.
Ability to focus and maintain concentration in tasks for extended periods.
Ability to work in environments with varying light conditions.

Nice To Haves

advanced degree preferred in a scientific/technical discipline

Responsibilities

Lead continuous gap analyses of regulatory requirements, and drive implementation of solutions aligned with business priorities.
Assist with the development and execution of a quality assurance strategy aligned with the company's objectives.
Direct regulatory inspection readiness, as well as QA support of client quality needs. Ensure that customer audit and regulatory inspections are managed appropriately including response to observations with corrective and preventative actions documented and communicated, as necessary.
Continuously improve core QMS processes: document control, CAPA, deviation and investigation management, audit response, and change control.
Foster a culture of quality and compliance for the organization.
Assist with the management and communication of departmental budgets and goals for the Quality Assurance unit.
Manage Quality Assurance team members, ensuring their development, engagement, and performance.
Drive cross-functional collaboration and alignment to achieve quality and compliance objectives.
Perform additional duties as assigned.