The VP, Product Quality Assurance will be responsible for the overall product quality assurance organization for Beam’s manufacturing facility in RTP, North Carolina, testing facility in Cambridge, Massachusetts and external activities. The ideal candidate will help shape and drive the Product Quality Assurance culture, fostering a proactive, phase appropriate quality focused approach, with close partnership and understanding of key stakeholders including Quality Systems, Clinical Quality Assurance, Quality Control and Technical Operations functions. If you are passionate about providing critical therapies and want an opportunity to grow and lead a Product Quality Assurance with established and dynamic thought leaders, then this is the opportunity for you. The position will report into Beam’s SVP, Regulatory Affairs and Quality and is based out of NC.
- Provide clear leadership and strategic direction and implement a quality assurance strategy that is aligned with company objectives, including a clear vision for the structure and role of the Quality Assurance.
- Develop, implement, maintain and continually assess a quality assurance department for applicable regulated activities to meet internal company standards and external requirements.
- Responsible with providing quality assurance oversight and support contract manufacturers across all phases of development and commercial.
- Serve as the lead for compliance with GMP requirements for multiple products.
- Define and manage Product Quality Assurance departmental budget to support company objectives.
- Build partnerships with cross-functional key groups to ensure that strategic business goals are met through the sharing of knowledge and expertise.
- Monitor, investigate and ensure resolution of problems with products, processes, and/or the QMS.
- Work closely with team members and external partners on internal and external quality audits and reinforce adherence to standard operating procedures.
- Oversee release of the company’s products for distribution and ensure that all released products meet their specifications.
- Contribute to review and approval of product labeling and packaging to ensure that they conform to regulatory requirements.
- Individual will also sit on the overall Quality Leadership team for Beam Therapeutics under Beam’s SVP, Regulatory Affairs and Quality.
- Individual will act as a leader in the Beam Quality Assurance organization and a member of the NC Leadership Team. As such, the individual will help define, communicate, and drive the Quality vision and mindset of the entire company in close collaboration with the Beam’s SVP, Regulatory Affairs and Quality.
- Ensures appropriate escalation to Senior Management of significant issues that may impact patient safety, product quality, supply, regulatory compliance or the company brand image.
Embodies Beam’s cultural values and aligns daily actions with departmental goals and company culture.
- Bachelors or Advanced degree in a scientific discipline.
- 15+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
- 8+ years of Quality management experience.
- Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions.
- Experience interacting with regulatory health authorities at pre- and post-approval inspection.
- Solid knowledge of global regulations and standards.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Excellent team building, leadership and management skills.
- Excellent listening, communication and interpersonal skills fostering team spirit.
- Consistent delivery of high-quality work at all times.
- Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives.
- Ability to travel up to 20%.
- Must be able to work onsite in RTP NC.