Senior Manager/Associate Director, Clinical GCP Quality

Company OverviewBeam 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 Senior Manager Associate Director - Clinical GCP Quality to join our growing Quality team. The Senior Manager Associate Director - Clinical GCP Quality will be responsible for quality aspects of Beam's clinical studies and overall Good Clinical Practice (GCP) as the company grows and continues to evolve from a research and discovery (R&D) company to a broader organization moving products though the clinical pipeline to commercial launch and growth. Reporting to the Senior Director - Clinical GCP Quality, this position will be a key member of Beam's Quality organization, as well as clinical study team(s) working with Clinical Development functional-area leads to ensure appropriate levels of clinical compliance and quality. Additionally, this position may assist Non-clinical Development (NCD) and Clinical Bioanalytics & Translational Sciences (CBTS) colleagues with qualification activities of third-party laboratories.Responsibilities:Assist the Senior Director - Clinical GCP Quality in helping to define and drive the clinical compliance and quality vision and mindset within the company.Continue to improverefine Beam's risk based GCP compliance program as the company moves from developmental to commercial (i.e., R&D, clinical research pipeline, commercial launch, growth).Ensure appropriate quality systems are in place to qualify clinical and non-clinical suppliers, which may include laboratories conducting regulated activities (clinical and non-clinical), clinical sites, and clinical study-related documents as they relate to GCP compliance.Oversee clinical compliance and quality within the context of a clinical study team(s).Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP.Ensure appropriate escalation of significant issues that may impact patient safety, the reliability of clinical study results, product quality andor supply, regulatory compliance, andor company brand image.Partner with Sr. Director on strategy for managing multiple suppliers including full service CROs.May assist NCD and CBTS with qualificationrequalification activities (questionnaires, audits, quality technical agreements, etc.).May provide GxP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findingsobservations, including corrective and preventive actions (CAPAs).May assist in preparation for health authority inspections at Beam, suppliers, andor clinical sites.Qualifications:University degree in scientific disciplinelife sciences OR equivalent experience in biotech or pharmaceutical industry10+ years of relevant experience in quality, 5+ in a GCP environment with at least three years of demonstrated experience working with multi-disciplinary functional areas. Level will be commensurate with experience.Knowledge and experience in a GLP environment is preferred.Solid knowledge of global regulatory requirementsstandards for the pharmaceutical, biotech, or vaccine industry (experience in cell andor gene therapies, a plus).Positive approach.Excellent interpersonal effectiveness and writtenverbal listeningcommunication skills.Excellent computer skills (quality and document management systems, clinical study-related systems (e.g., electronic data capture, interactive response technology, clinical trial management, etc.), and Microsoft products and services (e.g., Excel, PowerPoint, Visio, Word, etc.).Highly attentive to details and able to work well as part of a team.Demonstrates consistent quality, judgment, accuracy, speed, and creativity.Takes initiative in making improvement suggestions to promote operational goals.Applies quality concepts and company policiesstandards to resolve issues of moderate complexity in an effective manner.Facilitates designing processes with quality built in from the beginning.Identifies and uses good judgment to handle out-of-compliance scenarios.Ability to work independently.

Created: 2025-02-21