Beam Therapeutics

Associate Director, Treatment Center Quality

Cambridge, MA · Director · Full-time

Sponsorship not specified$185k-$225kDetected 6 days ago

GCPAuditingProcurementCustomer SupportGMPFDA RegulatoryCRISPRCell CultureCommunicationWritingLean ManufacturingGxP

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.

Qualification: Lead and manage both the onboarding and qualification process for new and existing commercial suppliers (e.g., treatment centers and transportation providers), including pre-classifications and quality system evaluations/reevaluations including identification of quality risks and development of mitigation strategies.
Agreement Management: Draft, negotiate, and maintain Quality and Technical Agreements.
Risk Management: Maintain oversight of treatment centers, identifying supply and quality risks while developing proactive mitigation strategies.
Drives continuous improvement on expectations regarding adherence to SOPs, ensuring compliance with timelines and due dates, engaging the correct stakeholders, and improving Quality Event KPIs.
identify potential gaps or improvements, and own and drive solutions as needed.
Maintain and update the Qualified Supplier List (QSL).

12+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality, with 4+ years' experience working with Veeva.
Direct experience with managing commercial treatment centers and executing audits.
Working knowledge of US and EU cGMP regulations and guidance including knowledge of FACT and JACIE accreditation.
Excellent verbal and written communication skills (technical writing), detail-oriented personality, and ability to work collaboratively across functions.
Experience with Lean Manufacturing and/or Continuous Improvement efforts.
Ability to communicate throughout all levels of the organization.
Experience interacting with regulatory health authorities' inspections.
Applies Quality concepts to resolve issues of moderate complexity in an effective manner.
Strong, positive team player who has a customer service approach and is solution-oriented.
Attention to detail and adherence to timelines.
Independently troubleshoots problems and issues

Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, or related discipline, or its equivalent, is preferred.
ASQ CQA audit certification is preferred.
Knowledge of aseptic processing/cell culture/cell and gene therapy manufacturing, and analytical testing is preferred.

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.