Director, Quality Systems and Compliance

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:

Beam is seeking a highly talented and motivated Director to join our Compliance and Quality Systems team. The Director will be responsible for supporting Inspection readiness, Supplier Qualification including oversight of audits, and Compliance including deviations, change controls and CAPAs. This role oversees the Quality Management System (QMS) for Beam Therapeutics internal and external operations, specifically partnering with Veeva, external auditing partners, and external suppliers. This role will support cross-functional operations to ensure that systems and processes are compliant with GxP compliance areas (GLP, GCP, GMP, GDP, GVP) as the programs move from clinical to the commercial phase.

This role will work with all sites and functions to ensure initiatives related to these areas are optimized and executed appropriately.

This is a full-time position that is based in Beam NC, with up to 25% potential travel.

Primary Responsibilities:

• Ensuring organization is prepared for regulatory inspections including pre-approval inspections, audits, and inspections by external bodies, focusing on documentation, training, and maintaining compliance.
• Create and maintain comprehensive plans for inspections, audits, and regulatory filings, ensuring all necessary documentation and processes are in place.
• Participate in audit preparedness/response both internally and externally.
• Supporting GxP Auditing for suppliers/system vendors including audit preparation and audit report follow-up.
• Supporting and may participate in regulatory inspections.
• Leading team responsible for qualification and onboarding suppliers, coordinating and conducting audits as required with an emphasis on managing Quality Technical Agreements (QTAs).
• Coordinating supplier data and conduct appropriate review of deliverables, including managing supplier status.
• Providing data for Senior Management Meetings (not limited to, Quality Management Review and Quality Council, GMP QA/Quality Functional review forums).
• Developing and delivering training programs to ensure employees are trained on inspection readiness procedures and regulatory requirements.
• Responsible for reviewing and approving assigned QMS records, including process deviations, change controls, CAPAs, Continuous Improvements, SCARs, and Supplier Change Notifications, and providing timely constructive feedback.
• Provides quality support in resolving Veeva quality events regarding material, product, testing, environmental, facility, and equipment issues internally and for CDMOs/CTLs.
• Acts as a Change Agent in culture improvement and sustainment regarding compliance with Quality Event timelines and outcomes.
• Drives continuous improvement on expectations regarding adherence to SOPs, succinct critical writing language, proper structure of an investigation, ensuring compliance with timelines and due dates, engaging the correct stakeholders, and improving Quality Event KPIs.
• Participate in the continuous improvement of applicable quality systems for Beam; identify potential gaps or improvements, and own and drive solutions as needed.
• Perform Quality review of data, reports, executed records, and other documentation, as required.
• Edit, review, and approve SOPs, deviations, change controls, and CAPAs for appropriateness and completeness and to meet internal processes and regulatory expectations.
• Support the development of harmonized/streamlined/standardized processes and supplemental documents (including Work Instructions created or maintained) governing the management and usage of Quality Systems.

Qualifications:

• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, or related discipline, or its equivalent, is preferred
• 15 years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality, with 4 years’ experience working with Veeva
• ASQ CQA audit certification is preferred
• Direct experience with managing suppliers and executing supplier audits
• Working knowledge of US and EU cGMP regulations and guidance
• Experience interacting with regulatory health authorities’ inspections
• Experience with Change Management and guiding team members through cultural improvements
• Participation in a formal root cause analysis training program such as Kepner-Tregoe, Conger Elsea, etc.
• Experience and/or training in technical writing
• Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
• Facilitates designing processes with Quality built in from the beginning.
• Applies Quality concepts to resolve issues of moderate complexity in an effective manner
• Strong team player who has a customer service approach and is solution-oriented
• Attention to detail and adherence to timelines
• Excellent listening, communication, and interpersonal skills fostering team spirit
• Consistent delivery of high-quality work at all times
• Experience with Lean Manufacturing and/or Continuous Improvement efforts
• Ability to communicate throughout all levels of the organization
• Independently troubleshoots problems and issues; called upon to train or assist others for a large portion of the job
• Demonstrates consistent judgment, quality, accuracy, speed, and creativity
• Good listening and communication skills
• Positive Approach
• Knowledge of aseptic processing/cell culture/cell and gene therapy manufacturing, and analytical testing is preferred