layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Associate Director, Product Quality Assurance at Beam Therapeutics | LAYIQ

Primary responsibilities encompass all aspects of Quality support for GMP operations. Quality oversight will include external GMP operations (ex. CDMOs, CTLs) and internal analytical operations.
Responsibilities for quality oversight will also extend to support in other areas of Beam that may support early phase GMP activities.
Responsible for the core interface and relationship with CDMOs and other external partners from a quality perspective.
Use sound judgement and critical thinking to develop solutions and drive risk analysis and mitigation strategies.
Create and ensure appropriate quality systems are in place to support analytical testing and product release in a compliant and timely manner and routinely monitor performance to established targets.
Ensure appropriate systems are in place for follow up and closing investigations and audit observations.
Ensure that exceptions are analyzed for corrective preventative actions and product impact.
Provide technical expertise for quality decisions.
Evaluate facility, procedures, equipment, personnel and processes to ensure that they consistently deliver product that meets all applicable requirements.
Oversee all aspects of Quality related to the manufacture of products externally and to the testing of products internally and externally.
Oversee analytical method and instrument qualification/validation relative to Beam internal testing.
Provide leadership, guidance, and direction to staff consistent with cGMP.
Evaluate and sign off on compliance documentation as required.
Oversee batch record review and assure proper batch release documentation.
Assure appropriate reviews and approvals for manufacturing and analytical testing records in support of product release.
Take lead role in organizing and completing investigations, coordinating with other departments involved, and driving closure in a timely manner.
Provide GxP auditing support for contract service providers.
Ensure adherence to GxP requirements and SOPs.
Embody Beam’s cultural values and align daily actions with departmental goals and company culture.

Associate Director, Product Quality Assurance

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