Director – Product Quality Assurance
Posted on 2/9/2024
Beam Therapeutics

201-500 employees

Pioneering precision genetic medicines through CRISPR base editing
Company Overview
Beam Therapeutics, established in 2018, is a pioneer in the field of genetic medicine, utilizing CRISPR base editing to create precise, permanent alterations to single bases in DNA and RNA without breaking the strands. The company's culture is characterized by a community of fearless innovators, rigorous and honest research, open-mindedness, and commitment to each other. Their competitive advantage lies in their unique delivery strategy, which includes a range of clinically validated technologies such as electroporation, nonviral, and viral delivery modalities, positioning them as a leader in the genetic medicine industry.
Biotechnology

Company Stage

N/A

Total Funding

$689M

Founded

2017

Headquarters

Cambridge, Massachusetts

Growth & Insights
Headcount

6 month growth

-10%

1 year growth

-10%

2 year growth

32%
Locations
Durham, NC, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Apache Beam
Management
Quality Assurance (QA)
Customer Service
CategoriesNew
QA & Testing
Requirements
  • Bachelors or Advanced degree in a scientific discipline
  • 10-15 years’ experience in the pharmaceutical/biotech industry
  • 6-8 years of Quality management experience
  • Solid knowledge of global regulations and standards
  • Must live local to the RTP area and able to come onsite daily
Responsibilities
  • Lead and support the Beam Quality Assurance organization
  • Responsible for the overall quality oversight and compliance systems at the manufacturing facility
  • Responsible for the review and QA oversight of validation Commissioning, Qualification, and Validation (CQV) effort of the various startup phases of the facility build
  • Responsible for establishing a QA compliance organization for the facility to ensure GMP compliance in manufacturing and testing
  • Responsible for managerial responsibilities to lead and support to meet functional and facility goals and objectives
  • Creation and management of the Site Master File for the NC facility
  • In collaboration with Operations, provides both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations
  • 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
  • Provide leadership, guidance, and direction to staff consistent with cGxP
  • Supports other members of the Quality Team and organization during its growth period in aspects not related to the core responsibilities of the Quality Systems area
Desired Qualifications
  • Experience in leading teams associated with elements of Quality and Quality Control/Analytical as part of overall background is preferred
  • Experience interacting with regulatory health authorities at pre- and post-approval inspection
  • 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
  • Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives