Director, Product Quality Assurance

Company Overview:

Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

The Director, Product Quality Assurance (QA) will be responsible for leading the product quality assurance group at Beam’s manufacturing facility in RTP, North Carolina. The position will have quality oversight for manufacturing, testing, and validation/qualification at the RTP facility. The BEAM NC facility is a clinical phase manufacturing plant with the intent to move several programs to commercial within the same facility. The ideal candidate will help shape and drive Quality culture, fostering a proactive, phase appropriate quality focused approach, with close partnership and understanding of key stakeholders including Compliance and Systems, MS&T, Manufacturing, Quality Control and Supply Chain functions.  The position is an onsite role in RTP NC and will report into Beam’s VP, Product QA.

Responsibilities:

• Lead and support the Beam Quality Assurance organization and will help define, communicate, and drive the Quality vision and mindset of the entire company in close collaboration with the VP, Product QA.
• Oversee Quality and compliance systems at the manufacturing facility (in coordination with global quality processes and personnel).
• Support and execute quality processes for the site, ensuring rollout and connection to global systems and processes.
• Review and oversee QA aspect of validation Commissioning, Qualification, and Validation (CQV) effort of the various startup and buildout phases of the facility build.
• Lead the QA compliance organization for the facility to ensure GMP compliance in manufacturing and testing, exception management, and overall product lot review and disposition.
• Ensure batch disposition-related activities are executed with a quality and compliance focus in a timely manner.
• Work and coordinate with other members of the greater quality organization (outside of the NC organization) to assist in developing, implementing, refining, aligning, and providing input to the overall quality processes growth and evolution over time.
• Responsible for managerial responsibilities in support of departmental, site, and corporate objectives.
• Oversee and execute quality risk management activities for the site, including maintenance of the site risk register.
• Assist in implementation of quality metrics for the facility and ensure that a management review process is maintained. 
• Provide support for external visits and regulatory inspections.
• Manage the Site Master File for the NC facility.
• In collaboration with Operations, provide both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations.
• Ensure appropriate escalation to Senior Management of significant issues that may impact patient safety, product quality, supply, regulatory compliance or the company brand image.
• Support due diligence audits, site selection, and qualification of external partners as necessary.
• Define clear Quality objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions and drive risk analysis and mitigation strategies.
• Provide leadership, guidance, and direction to staff consistent with cGxP.
• Support other members of the Quality Team and organization during its growth period in aspects not related to the core responsibilities of the Quality Systems area.
• Embodies Beam's cultural values and aligns daily actions with departmental goals and company culture.

Qualifications:

• 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.
• Experience in leading teams associated with elements of Quality and Quality Control/Analytical as part of overall background is preferred.
• 6-8 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.
• Must live local to the RTP area and be able to come onsite daily.