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)
