Job Locations US-MA-Framingham

ID

2024-1534

Category

Quality

Position Type

Regular Full-Time

This position will be required to interact with all departments within the company and to proactively support GMP compliance. The role provides an opportunity to enhance quality skills and experience within a GMP environment while owning/leading complex processes and programs.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Key responsibilities:

• Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure inspection readiness.
• Manage/coordinate the internal process for batch release, working closely with Quality Control, Manufacturing and Supply Chain.
• Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration, marketing authorization and all other applicable requirements through review of testing records, investigations, non-conformances and out-of-specifications as part of the batch release process.
• Provide batch disposition and subsequent release and issuance of Certificate of Analysis/Conformance.
• Coordinate cross-functional activities associated with batch release, ensuring corrections are completed and associated batch documentation and investigations are closed out in a timely manner.
• Responsible for final approval and authorization of finished product for shipment and subsequent approval of packaging events.
• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance, including a summary of findings for any batch that does not meet the standard requirements for final disposition.
• Drive improvement of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
• Oversee progression of batch related Out of Specification investigations and deviations to ensure timely progression for release.
• Collect and provide input to and communicate performance metrics and data trends to Management for Batch Release related activities.
• Lead, mentor and coach quality assurance personnel through development of training to support batch release activities/processes.
• Support internal/external batch release audits as Subject Matter Expert.
• Participate in the Change Control Review Board as needed.
• Interface and provide support to internal customers.
• Participate in Risk assessments.
• Provide QA input and approvals to assist in and drive projects as needed.

Other responsibilities

• Drafts, reviews, provides oversight to content, and approves controlled documents which may include but is not limited to standard operating procedures, validation documents, material specifications, etc.

Educational requirements:

• Bachelor degree required; MSc or PhD preferred

Experience and skill requirement:

• 6-7+ years of quality experience in biopharmaceutical industry.
• Strong written and verbal communication skills to interact with other functions.
• Adaptable, flexible, and able to manage change.
• Demonstrate strong organization skills related to priorities and workload.
• Ability to solve problems independently and within a team environment.
• History of decision making leading towards continuous improvement

Location:

This position is based in our Framingham location and typically has a 5-day on-site expectation.

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