Company Overview:

Beam Therapeutics is a biotechnology company 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 Specialist / Senior Specialist to join our Quality Systems and Compliance team. The Specialist will be responsible for supporting the Quality Management System (QMS) for Beam Therapeutics internal and external operations, specifically partnering with Veeva, Supplier Qualification, and Auditing. 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 can be based in Beam Cambridge or NC, with up to 25% potential travel.

Primary Responsibilities:

• Provides technical guidance for operating system metrics, ensuring processes are effectively harmonized, maintained, and monitored globally.
• Drives generation of standardized metric and trending reports (i.e., Quality KPIs, weekly overdue compliance activities).
• Responsible for review and approval of 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.
• Provides data for Senior Management Meetings (not limited to, Quality Management Review and Quality Council, GMP QA/Quality Functional review forums).
• Acts as a Change Agent in culture improvement and sustainment regarding compliance of 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 owning and driving as solutions as needed
• Responsible for supporting and may participate in regulatory inspections
• Coordinate supplier data and conduct appropriate review of deliverables, including managing supplier status.
• 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.
• Participate in audit preparedness/response both internally and externally.
• Support GxP Auditing for system vendors including audit preparation and audit report follow-up.
• Assist with qualifying and onboarding suppliers, coordinating and conducting audits as required with an emphasis on managing Quality Technical Agreements (QTAs).
• Support the development of harmonized/streamlined/standardized processes and supplemental documents (including Work Instruction creation or maintenance) governing 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
• 10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality, with 2+ years’ experience working with Quality Management Systems
• Working knowledge of US and EU cGMP regulations and guidance
• Experience with Change Management and guiding team members through culture 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
• Experience interacting with regulatory health authorities’ inspections
• 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