Position Overview

The Senior Specialist, Compliance will be responsible for supporting the Quality Management System (QMS) for Beam Therapeutics internal and external operations, specifically partnering with team members of functional areas who initiate and own Veeva Quality Events. This position is a full time position and ideally will sit in Beam NC but would also support Beam Cambridge, with up to 25% potential travel.

This role will help to instill the mindset of how Quality Events are documented. The role will support cross-functional operations to ensure that systems and processes are maintained to ensure compliance to Good Manufacturing Practices, and ultimately to Good Distribution Practices as the programs move from clinical to the commercial phase. This role will work with all sites and functions to support a standardized process for managing GxP Deviations, Change Controls, Product Technical Complaints, and Corrective and Preventive Actions (CAPA) throughout their lifecycle.

As a global resource, this role may perform, but is not limited to, additional quality responsibilities as needed to support internal and external manufacturing and continued operational needs, such as release of incoming raw materials and consumables, supporting product disposition, batch record review, and Quality Purposeful Presence on the floor for critical operations as necessary. The position will report into Global Quality Systems.

Primary Responsibilities:

• Provides technical guidance for the operation of 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, OOS investigations, change controls, CAPAs, Continuous Improvements, SCARs, and Supplier Change Notifications and providing timely constructive feedback
• Provide Quality support with resolution of Veeva Quality Events regarding material, product, testing, environmental, facility and equipment issues internally and for CDMOs/CTLs.
• Responsible for monitoring Quality Event KPIs

• 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
• Facilitates Change Control, Deviation and CAPA meetings and escalate issues as needed
• 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 Qualiy Event KPIs

• Partner with functional team members to ensure CMO Quality Events are entered into Veeva Quality, closed in a timely fashion, and are linked to the appropriate “Organization” in Veeva Quality
• 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

• Partner with Quality Systems (Training) on identified gaps where additional training content may be needed for functional area Quality Event owners

• Support additional Quality needs, such as release of incoming raw materials and consumables, approval of validation protocols, supporting product disposition, batch record review, etc.

Embodies Beam’s cultural values and aligns daily actions with departmental goals and company culture.

Qualifications:

• Bachelor’s or Advanced degree in a scientific discipline
• 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
• 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
• Applies Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
• Experience interacting with regulatory health authorities’ inspections
• Strong team player that 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