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 oversight for the manufacturing, testing and validation activities including raw material release. 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.
• Responsible for the overall quality oversight and compliance systems at the manufacturing facility (in coordination with global quality processes and personnel).
• Responsible to support and execute quality processes for the site, ensuring rollout and connection to global systems and processes.
• Responsible for the review and QA oversight of validation Commissioning, Qualification, and Validation (CQV) effort of the various startup phases of the facility build.
• Responsible for establishing a QA compliance organization for the facility to ensure GMP compliance in manufacturing and testing, exception management, and overall product lot review and disposition.
• Individual will work and coordinate with other members of the greater quality organization (outside of the NC organization) to assist in developing, implementing, refining, and providing input to the overall quality processes growth and evolution over time.
• Responsible for managerial responsibilities to lead and support to meet functional and facility goals and objectives.
• Responsible to assist in implementation of quality metrics for the facility and ensure that a management review process is in place. 
• Responsible to provide support for external visits and regulatory inspections.
• Creation and management of the Site Master File for the NC facility.
• In collaboration with Operations, provides both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations.
• Ensures 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.
• Supports 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.
• 10-15 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 able to come onsite daily.