Beam Therapeutics

Senior Director, Product Quality Assurance, Cambridge

Cambridge, MA · Director · Full-time

Sponsorship not specified$260k-$320kDetected 37 days ago

AuditingCustomer SupportGMPCRISPRResearchLeadershipCommunicationGxP

About the role

Beam 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 with integrated gene editing, delivery and internal manufacturing capabilities.
This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs.

Primary responsibilities encompass all aspects of Quality support for GMP operations. Quality oversight will primarily encompass external GMP operations (ex. CDMOs) and QC support in Cambridge.
for quality oversight will also extend to support in other areas of Beam that may support GMP activities.
Responsible as a key relationship manager CDMOs/external partners from a quality perspective.
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.
Create and ensure appropriate quality systems are in place to support product release in a compliant and timely manner and routinely monitor performance to established targets.
Oversee Quality support for QC activities in Cambridge, including testing, method qualification/validation, instrument qualification, and quality system records related to QC activities.
Evaluate facility, procedures, equipment, personnel and processes to ensure that they consistently deliver product that meets all applicable requirements.

Bachelors or Advanced degree in a scientific discipline.
15+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality.
Must have CT/GT/biologics experience.
7+ years of Quality management experience with a successful track record in managing CDMOs as well as internal QA systems in a virtual environment.
Experience in auditing/vetting of CDMOs.
Established expertise and training in GxP systems.
15+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality. Must have CT/GT/biologics experience.
Understanding of worldwide requirements of cGMP and quality systems for commercial and clinical products.
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.
Ability to evaluate Quality Systems and drive value added enhancements.
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.
Excellent team building, leadership and management skills.
Excellent listening, communication and interpersonal skills fostering team spirit.
Consistent delivery of high quality work at all times.

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.

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.

This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.