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Associate Director of Quality Systems (GxP)

Company: Beam Therapeutics
Location: Somerville
Posted on: January 12, 2021

Job Description:

The Associate Director of Quality Systems will act as a leader in the Quality organization and will assist in developing, implementing, administering, and growing Beam---s Global Quality Management System related to all areas of GxP operations, including specific focus areas of Data integrity and Computerized Systems Lifecycle and Validation. The position will be critical to the overall build strategy and growth of the Quality organization for Beam as the company grows and evolves from a Research and Discovery company to a broader organization moving products through the clinical pipeline to commercial launch and growth. The Quality Management System (QMS) at Beam is intended to grow as an integrated Quality Structure that oversees all aspects of the GxP compliance areas (GLP, GCP, GMP, GDP, GVP, and others as applicable to the stage of the company) under a unified single quality umbrella.The Associate Director of Quality Systems will be a key leader with accountability to the Senior Director, Quality Systems. The role will be responsible for developing the strategy for data integrity and management and enabling electronic platforms including CSV program and act as the overall QMS lead for these aspects for the GxP areas across all Beam locations in partnership with applicable operational units. (Clinical operations, Technical Operations, IT, etc). In addition the role supports execution of Quality priorities and processes across the Quality functions during this growth period in aspects not related to the core responsibilities of the Quality Systems area.Primary Responsibilities:Individual will act as a leader in the Beam Quality organization to help convey the quality vision and mindset to stakeholders. Primary Responsibilities encompass the oversight and execution of key Quality Systems for Beam, including guidance and direction to staff and across Beam---s various departments consistent with cGxP.Act as a core owner and Business Process Owner (BPO) for Data Integrity and Computerized System Lifecycle and Validation and related processes.In partnership with IT, administer and maintain all GxP computerized systems including managing service contracts with GxP software suppliers.Drive all activities associated with the Computerized System Lifecycle including partnering with business owners for solution analysis and user requirements identification, software selection, and project execution including Validation Master planning, risk management, execution of qualification activities and management of third-party resourcing for project activities.Drive development and deployment of Data Integrity policies and strategy for the company.Ensure that Quality Systems are designed and operating in a way to provide appropriate support in all GxP areas of the company: GLP, GCP, GMP, GDP, GVP operations and others depending on the stage of the company.Acts as a key leader within the Quality Systems team in developing the overall strategy and details on the enabling electronic platform used by the Quality Systems processes.Support supplier management activities for software vendors and other key suppliers as necessary.Assist in defining clear Quality objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions and drive risk analysis and mitigation strategies.Ensure appropriate systems are in place for change management and periodic monitoring for computerized systems.Provide technical expertise for quality decisions as needed.Takes lead role in evaluating continuous improvement options for the Quality Systems post initial implementation.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 years--- experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.Proven ability to lead validation activities of complex IT GxP projects.Experience validating Veeva is strongly preferred.Possess expert knowledge in quality and compliance related to computerized systems GxP regulations (21 CFR Part 11, Annex 11 & GAMP5, etc.)Understanding of worldwide requirements of cGxP and quality systems for Clinical and Commercial products is preferred.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.Established expertise and training in GxP systems.Solid knowledge of global regulations and standards.Ability to evaluate Quality Systems and drive value added enhancements.Strong team player that has a customer service approach and is solution oriented.

Keywords: Beam Therapeutics, Somerville , Associate Director of Quality Systems (GxP), Executive , Somerville, Massachusetts

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