Assoc. Director, Quality Assurance Validation

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.

Franklin Biolabs, Inc. is in search of an Associate Director, QA Validation.

Key Responsibilities include:

• Project lead validation projects for equipment and enterprise systems. Ensuring validation projects stay on schedule, compliant and drive to closure.
• Act as the QA CSV reviewer and approver for critical CSV documentation, including specifications, validation protocols, and reports, ensuring compliance with industry regulations.
• Contribute to the execution of GxP computer system validation lifecycles and QA-CSV strategies to meet company goals.
• Lead and manage both internal and contract resources to provide effective support for CSV-related business needs.
• Participate in routine and complex internal and external audits, including vendor assessments, to evaluate compliance with GxP regulations and CSV requirements.
• Act as a CSV compliance expert, offering guidance to the quality assurance team and GxP functions.
• Prepare and support regulatory inspection and client audit activities, including the preparation of responses to inspection findings related to CSV.
• Update and develop CSV-related policies, procedures, and templates based on the latest regulatory requirements and industry trends.
• Proactively identify opportunities for process improvements within CSV activities, ensuring alignment with industry best practices.
• Review and approve equipment in BMRAM. Ensuring information is accurate and complete.
• Continuously monitor all validated system, ensuring they remain in a validated state.
• Perform additional duties as assigned.

Education and Experience:

• Minimum of BS/BA degree in Computer Sciences, Life Sciences or Engineering, required.
• 7-10 years of direct experience in biopharmaceutical or biotech CSV, or equivalent.
• Formal certifications or education required: None.

Knowledge, Skills and Abilities:

• Deep understanding of CSV within the biopharmaceutical or biotech sectors.
• Demonstrated expertise in computer system validation, with experience managing and leading complex CSV projects.
• Strong working knowledge of Veeva® Quality Cloud systems.
• In-depth experience working with GxP systems and ensuring compliance with regulatory requirements.
• Ability to communicate clearly and effectively, both verbally and in writing, to interact with team members, clients, vendors and other third parties.
• Ability to collaborate effectively with individuals across various disciplines to ensure alignment.
• Ability to use digital communication tools (video conferencing, chat platforms etc.) to effectively collaborate with team members in hybrid and remote settings.

Travel:

• Ability to travel domestically and/or internationally up to 5% 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.

On-Site:

• This position requires full-time on-site presence at our Discovery Labs location.

Vision:

• 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.

Company Benefits:

• 401(k)
• 401(k) Matching
• Health insurance
• Dental insurance
• Vision insurance
• Health Savings Account and Flexible Spending Account
• Paid Time-Off
• Company Paid Holidays
• Personal Floating Holidays
• Short-Term and Long-Term Disability
• Life and AD&D insurance (Group & Voluntary)