Franklin Biolabs emerges from the esteemed legacy of Dr. Jim Wilson's laboratory, a beacon of innovation in vector technology for over three decades. Building on this rich heritage, Franklin Biolabs is poised to redefine the landscape of the global genetic medicines industry.
As a Contract Research Organization (CRO), Franklin Biolabs offers a comprehensive suite of services spanning from discovery through clinical manufacturing. Our goal is to empower our partners by providing unparalleled solutions that drive the advancement of genetic medicines. Leveraging decades of expertise and a commitment to excellence, we bridge the gap between groundbreaking research and ensuring that transformative therapies reach those who need them most.
This position is responsible for developing and implementing quality assurance strategies, policies, and procedures to maintain the highest level of product and service excellence.
They will have had demonstrated experience in strategic leadership, regulatory compliance, supplier quality management, customer satisfaction, process improvement, quality metrics and reporting, and risk management. This position is responsible and accountable for all aspects of Quality Assurance for the manufacturing of research and GLP grade AAV products, non-clinical laboratory studies, testing, and release of AAV products for clients. The VP of Quality will offer direct and indirect guidance and support to personnel in both a GLP and cGMP testing environment.
This individual must possess and apply a broad knowledge of Quality principles, practices, and procedures with an astute ability to rank priorities in order of importance and feel comfortable making decisions on quality matters. They must also manage and support a variety of processes including those that are key to a Contract Research organization (CRO). The VP of Quality is also responsible for managing electronic system compliance. This position must be able to lead and work with cross-functional teams and track projects to completion requiring experience in a cGMP environment plus demonstrated familiarity with standard quality concepts, practices, and procedures to drive continuous improvement initiatives and mitigate risks associated with quality assurance within a CRO.
Essential Duties and Responsibilities
- Develop and execute a comprehensive quality assurance strategy aligned with the company's objectives.
- Lead and oversee the Quality function for the company, ensuring compliance with regulatory requirements and industry standards.
- Be thoroughly knowledgeable of Standard Operating Procedures (SOPs), including but not limited to GLP and cGMP Quality requirements, and maintain a knowledge base on an ongoing basis.
- Demonstrate knowledge of and lead the Quality Culture for the organization.
- Prepare, communicate, and manage budgets and goals for the Quality Assurance unit.
- Supervise and guide internal audits of various departments/processes.
- Oversee and perform Quality Assurance document control activities, including processing change requests, manufacturing records, and other documents.
- Oversee QA activities, including managing project priorities, collaboration with Engineering & Production, and development of process-related SOPs, either self or through direct reports.
- Write, revise, review and/or approve SOPs, controlled forms, and related documents to ensure best practices and current operations.
- Responsible for completing the disposition of all in-process and finished products, ensuring compliance with all applicable regulations.
- Address observations or recommendations as well as implement corrective/preventive actions as needed.
- Provide strategic guidance and support for product quality issues, deviations, investigations, and complaints, as needed.
- Prepare and approve quality agreements.
- Participate in process improvement teams to provide quality input and direction. Ensure that documentation of improvements is completed and approved as needed.
- Ensure compliance with GLP, GMP, FDA, USDA, and all other regulatory requirements in accordance with company policy.
- Ensure PAI and BIMO inspection readiness, as well as QA support of client quality needs.
- Adhere to company safety requirements. Maintains a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.
People Management
- Lead and manage the Quality Unit and advise executive management of the Quality function for the entire organization, overseeing a team of Quality professionals and ensuring their development, engagement, and performance.
- Assign responsibilities, provide feedback and coaching, and take necessary actions in oversight of Quality Assurance as necessary.
- Provide mentorship, guidance, and support to Quality Assurance team members, fostering a culture of learning, collaboration, and continuous improvement.
- Establish clear goals and performance expectations for the Quality team, monitoring progress and providing regular feedback and coaching.
- Lead recruitment, hiring, and onboarding efforts for the Quality Unit, ensuring the team has the necessary skills and capabilities to support business needs.
- Drive cross-functional collaboration and alignment with other departments, such as Manufacturing, Regulatory Affairs, Program for Comparative Medicine, and Quality Control, to achieve quality and compliance objectives.
- Serve as a key representative of Quality in internal and external forums, including regulatory inspections, audits, and client interactions.
- Stay informed of industry trends, regulatory updates, and emerging technologies to inform Quality strategies and initiatives.
Qualifications
- BS required, MS or PhD preferred in a scientific/technical discipline with 15+ years of experience in a quality leadership position within the biological and/or pharmaceutical industry with specific experience in cell and gene therapy preferred.
- Significant experience supporting functional areas (e.g., PD, Manufacturing, QA, Engineering, QC) preferred.
- Demonstrated experience with writing/reviewing deviations, laboratory investigations, and OOS investigations. Expertise in root cause analysis a plus.
- Demonstrated experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.
- Solid knowledge of FDA and EMA regulatory requirements for ATMPs and biologics.
- Ability to apply GLP and cGMP regulations and international guidelines to all aspects of the position.
- Ability to write reports, business correspondence, and procedure manuals.
- Proven track record of successfully leading Quality initiatives and driving compliance in a regulated manufacturing 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, top management, public groups, and/or boards of directors.
- Strong leadership and people management skills, with the ability to inspire and develop high-performing teams.
- Must be able to assess and utilize software and customized programs to meet QA and the organizations’ business needs.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and levels of the organization.
- Strategic mindset with the ability to translate business objectives into actionable Quality strategies and initiatives
Application note
Franklin Biolabs is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at Franklin Biolabs via email, the Internet, or directly without a valid written search agreement for this role will be deemed the sole property of Franklin Biolabs and no fee will be paid in the event the candidate is hired
