Sr. Director, Clinical Quality Assurance

Beam Therapeutics Inc.•Cambridge, MA

60d•$250,000 - $310,000

About The Position

The Sr. Director, Clinical Quality Assurance will act as a leader in the Quality organization and will be responsible for the quality oversight for Beam's clinical trials and overall GCP (Good Clinical Practice). The position will be critical to the overall strategy and growth of the Quality organization for Beam as the company grows and evolves from Development to a Commercial organization in preparation for licensure. Reporting to the VP, Compliance, the position will be a key liaison with the Clinical Operations team, Clinical Development, Medical and Safety teams, programs teams, regulatory, and others back to the Quality organization. The position will take a leadership role responsible for developing and overseeing a company's global clinical quality assurance strategy to ensure compliance with regulations like Good Clinical Practice (GCP). Key duties include managing audits and inspections, implementing quality management systems, reviewing study documentation, and leading a high-performing team. This position requires extensive experience in a quality assurance role, often with a background in life sciences and strong leadership skills. The Director/Sr. Director of Clinical GCP Quality will be responsible for designing, delivering and executing the global clinical quality assurance strategy. Ensure clinical trials and research activities are compliant with GCP, FDA, ICH, and other international regulations and laws. Review and approve study-related documents, such as protocols, investigator brochures, and informed consent forms. Mentor and manage a high-performing CQA team. Collaborate with internal teams and engage with regulatory bodies and industry groups. The position will have overall responsibility to ensure initiatives related to clinical quality and compliance are optimized and executed appropriately.

Requirements

Bachelors or Advanced degree in a scientific discipline.
18+ years' experience in the pharmaceutical/biotech industry in clinical quality assurance.
3+ years of Quality leadership experience and team building experience.
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.
Solid knowledge of global regulations and standards.
Strong team player that has a customer service approach and is solution oriented.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Consistent delivery of high-quality work at all times.

Responsibilities

Strategy and oversight: Design, deliver, and execute the global Clinical Quality Assurance (CQA) strategy.
Compliance: Ensure clinical trials and research activities are compliant with GCP, FDA, ICH, and other international regulations and laws.
Audits and inspections: Conduct complex internal audits and external inspections of clinical sites, vendors, and internal processes.
Quality management: Oversee the quality management system and drive initiatives for continuous improvement.
Documentation: Review and approve study-related documents, such as protocols, investigator brochures, and informed consent forms.
Leadership: Build, mentor, and manage a high-performing CQA team.
Stakeholder engagement: Collaborate with internal teams and engage with regulatory bodies and industry groups.
Lead the clinical quality assurance group and help define and drive the Clinical Quality Assurance and compliance vision and mindset in close collaboration with the Clinical Operations and Clinical Development leads.
Define clear clinical quality assurance objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions, drive risk analysis and mitigation strategies.
Develop a risk based GCP compliance program and implement at Beam to enable clinical programs to progress through the clinical trials, per ICH E6 R3 guidance and global regulations.
Ensure appropriate quality systems are in place to audit CROs and vendors, clinical sites, regulatory documents as they relate to GCP compliance.
Provide GxP Auditing including audit preparation, execution of the audit and the audit report, and follow up to any finding(s) including CAPAs.
Oversee clinical quality assurance aspects related to execution of clinical studies.
Prepare for FDA/EMA/Health Authority inspections of the Sponsor, CRO, or clinical sites.
Provide leadership, guidance and direction to staff consistent with GCP.
Responsibilities include supporting and enabling appropriate Quality review of regulatory submissions, health authorities' (i.e. pre-filing meeting, filings, approval negotiations, post marketing commitments, annual reports, responses to questions, responses, and progress reports for regulatory commitments), and ensuring submissions are in line with the overall product strategy.
Ensures appropriate escalation to Senior Management of significant issues that may impact patient safety, product quality, supply, regulatory compliance or the company brand image.
Support due diligence audits, site selection, and qualification of external partners as necessary.
Define clear Quality objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions and drive risk analysis and mitigation strategies.
Supports other members of the Quality Team and organization during its growth period in aspects not related to the core responsibilities of the Clinical Quality area.
Embodies Beam's cultural values and aligns daily actions with departmental goals and company culture.