Sr. Product Quality Manager

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The Sr. Product Quality Manager serves as the designated Quality representative for assigned API products and client programs from development through commercialization and lifecycle management. The position serves as the Voice of Quality on cross-functional teams and acts as the primary quality interface between Bachem and its clients. The Sr. Product Quality Manager provides strategic and technical quality oversight throughout the product lifecycle, ensuring manufacturing processes, analytical methods, validation activities, technology transfers, specifications, and control strategies remain compliant, scientifically sound, and aligned with regulatory expectations.

The position focuses on strategic product quality leadership, serving as the Quality lead for complex development and commercial products and as a subject matter expert during client audits and regulatory inspections. The role leads complex risk assessments and control strategy development, drives quality strategy for commercial launches, and advances product lifecycle management initiatives across the product portfolio.

• Product Lifecycle Management:
  Serve as the Quality representative for assigned products across the lifecycle from development through commercialization and post-approval changes. Support product quality strategy and lifecycle management activities. Assess quality and compliance risks associated with process, analytical, specification, and supply chain changes. Support annual product reviews and ongoing product quality evaluations.
• Client & Project Team Leadership:
  Serve as the Voice of Quality on assigned project teams. Act as primary quality liaison with external clients. Communicate quality updates, risks, mitigation plans, validation status, and product quality issues to clients. Participate in governance meetings and technical reviews.
• Technology Transfer:
  Review and approve:
  Technology Transfer Plans, Technology Transfer Protocols, and Technology Transfer Reports. Support internal and external technology transfer activities. Ensure quality considerations are incorporated into control strategies and transfer packages.
• Validation Oversight:
  Review and approve:
  Process Validation Protocols and Reports, Continued Process Verification (CPV) Plans and Reports, Cleaning Validation Protocols and Reports, Analytical Method Validation Protocols and Reports, and Equipment Qualification documentation, as appropriate.
• Continual Process Verification (CPV):
  Support establishment and maintenance of product-specific CPV programs. Review process performance data and quality trends. Evaluate process capability and product quality trends. Partner with Manufacturing, Tech Ops, Engineering, and QC to identify opportunities for process improvement. Support investigation of adverse process trends and implementation of preventive actions.
• Product
  
  Risk Management:
  
  Participate in Quality Risk Management activities. Lead or facilitate product-specific FMEAs. Support development of:
  Manufacturing process controls, Critical process parameters (CPPs), Critical quality attributes (CQAs), and Control strategies. Participate in cross-functional reviews supporting creation and revision of batch production records.
• Specifications and Control Strategy Development:
  Provide quality oversight for:
  Raw material specifications, In-process specifications, Intermediate specifications, and API release specifications. Support specification establishment and lifecycle management. Ensure specifications remain scientifically justified and aligned with process capability, validation data, and regulatory commitments. Review specification revisions and associated change controls. Partner with…