Sr. Product Quality Manager

Bachem AG•Vista, CA

2d•$104,130 - $143,179

About The Position

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 is the Voice of Quality on cross-functional teams and the primary quality interface between Bachem and its clients. It provides strategic and technical quality oversight to ensure manufacturing processes, analytical methods, validation activities, technology transfers, specifications, and control strategies remain compliant, scientifically sound, and aligned with regulatory expectations. The role provides strategic product quality leadership for complex development and commercial products and serves as a subject matter expert during client audits and regulatory inspections. It leads complex risk assessments and control strategy development, drives quality strategy for commercial launches, and advances product lifecycle management initiatives across the product portfolio.

Requirements

Bachelor's degree in a science-related field.
10–15 years of GMP experience.
Skills in critically assessing SOPs, investigations, and project protocols for compliance requirements.
Ability to prepare reports for internal metrics and technical content and critically evaluate data summaries and conclusions.
Competence in cGMPs, 21 CFR 210 and 211, ICH Q7, and USP-NF.
Strong working knowledge of Risk Management.
Ability to create charts and graphs using Excel.
Excellent written and oral communication skills.
Proficient computer knowledge, including Microsoft Word, Excel, and PowerPoint.
Ability to organize effectively, multitask, and work in a fast-paced, deadline-driven environment.
Ability to manage without authority in a cross-functional, matrixed environment.
Ability to communicate proactively and in a solution-focused manner, including keeping management aware of potential issues.
Detail-oriented, with the ability to troubleshoot and resolve technical and analytical problems.
Ability to work independently and manage one's time.

Nice To Haves

Master's degree in a science-related field.
8+ years of peptide/API manufacturing experience.

Responsibilities

Serve as the Quality representative for assigned products throughout development, commercialization, and post-approval lifecycle management.
Support product quality strategy, lifecycle management activities, annual product reviews, and ongoing product quality evaluations.
Assess quality and compliance risks associated with process, analytical, specification, and supply chain changes.
Serve as the Voice of Quality on project teams and the primary quality liaison with external clients; communicate quality updates, risks, mitigation plans, validation status, and product quality issues.
Participate in governance meetings and technical reviews.
Review and approve technology transfer plans, protocols, and reports; support internal and external technology transfers and incorporate quality considerations into control strategies and transfer packages.
Review and approve process validation, continued process verification, cleaning validation, analytical method validation, and equipment qualification documentation, as appropriate.
Support the establishment and maintenance of product-specific continued process verification 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 process improvement opportunities; support investigation of adverse process trends and implementation of preventive actions.
Participate in Quality Risk Management activities and lead or facilitate product-specific FMEAs.
Support development of manufacturing process controls, critical process parameters, critical quality attributes, and control strategies; participate in cross-functional reviews to create and revise batch production records.
Provide quality oversight for raw material, in-process, intermediate, and API release specifications; support specification establishment and lifecycle management.
Ensure specifications are scientifically justified and aligned with process capability, validation data, and regulatory commitments; review specification revisions and related change controls.
Partner with QC, Analytical Development, Regulatory Affairs, and Tech Ops on specification strategy.
Support preparation for regulatory inspections and client audits, review product-related regulatory submissions, assess quality impacts of regulatory commitments and post-approval changes, and serve as a product quality subject matter expert during inspections.