Beam Therapeutics · 2 weeks ago
Sr. Director, Clinical Quality Assurance
Cambridge, MA
Full-time
Onsite
Director/Executive
$250K/yr - $310K/yr
18+ years expBeam Therapeutics is a biotechnology company committed to establishing a leading platform for precision genetic medicines. The Sr. Director, Clinical Quality Assurance will lead the quality oversight for clinical trials, ensuring compliance with regulations and managing a high-performing team.
BiotechnologyGeneticsMedicalTherapeutics
Responsibilities
Design, deliver, and execute the global Clinical Quality Assurance (CQA) strategy
Ensure clinical trials and research activities are compliant with GCP, FDA, ICH, and other international regulations and laws
Conduct complex internal audits and external inspections of clinical sites, vendors, and internal processes
Oversee the quality management system and drive initiatives for continuous improvement
Review and approve study-related documents, such as protocols, investigator brochures, and informed consent forms
Build, mentor, and manage a high-performing CQA team
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
Qualification
Required
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
Company
Beam Therapeutics
Beam Therapeutics is a biotechnology company developing precision genetic medicines through the use of base editing technology.
501-1000 employees
H1B Sponsorship
Beam Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (12)
2022 (9)
2021 (7)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.19B2025-03-10Post Ipo Equity· $500M
2021-01-19Post Ipo Equity· $260M
2020-02-11Post Ipo Equity· $207M
Leadership Team
John Evans
CEO
Christine Bellon
Chief Legal Officer
Recent News
2025-12-16
2025-12-09
Company data provided by crunchbase