Bachem

Develops and manufactures peptides and oligonucleotides

Sr. Product Quality Manager

Regulatory & Quality (Life Sciences)Updated on Nov 14

Full-timeVista, CA, USAIn-person

About the Job

Requirements

A bachelor's degree in a science-related field is required.
A master's degree in a science-related field is preferred.
10–15 years of GMP experience is required.
Critical assessment skills for SOPs, investigations, and project protocols to ensure compliance requirements are met.
Ability to prepare internal metrics and technical reports and critically evaluate data summaries and conclusions.
Competence in current good manufacturing practices, 21 CFR Parts 210 and 211, ICH Q7, and USP–NF.
Strong working knowledge of risk management.
Ability to create charts and graphs using Excel.
Proficiency with Microsoft Word, Excel, and PowerPoint.
Ability to organize and multitask in a fast-paced, deadline-driven work 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.
Attention to detail and ability to troubleshoot and resolve technical and analytical problems.
Ability to work independently and manage time effectively.

Responsibilities

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; and support annual product reviews and ongoing product quality evaluations.
Serve as the Voice of Quality on assigned project teams and the primary quality liaison with external clients; communicate quality updates, risks, mitigation plans, validation status, and product quality issues to clients; and participate in governance meetings and technical reviews.
Review and approve Technology Transfer Plans, Technology Transfer Protocols, and Technology Transfer Reports; support internal and external technology transfer activities; and ensure quality considerations are incorporated into control strategies and transfer packages.
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.
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 process-improvement opportunities; and 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 (CPPs), critical quality attributes (CQAs), and control strategies; and 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 remain scientifically justified and aligned with process capability, validation data, and regulatory commitments; review specification revisions and associated change controls; and 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 impact of regulatory commitments and post-approval changes; and participate as the product quality subject matter expert during inspections.

Desired Qualifications

At least 8 years of peptide/API manufacturing experience is preferred.

A brief overview

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.

What you will do

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 QC, Analytical Development, Regulatory Affairs, and Tech Ops on specification strategy.
Regulatory Support: Support preparation for regulatory inspections and client audits. Review product-related regulatory submissions. Assess quality impact of regulatory commitments and post-approval changes. Participate as product quality SME during inspections.

Qualifications

Bachelor's Degree in a Science related field required
Master's Degree in a Science related field preferred
10-15 years GMP experience required and
8+ years peptide/API manufacturing experience preferred and
Must have skills for the critical assessment of SOP’s, investigations, and project protocols for content that will meet compliance requirements
Ability to prepare reports for internal metrics and technical content and critically evaluate data summaries and conclusions
Must have competence of cGMPs, 21CFR 210, 211, ICH Q7 and USP-NF
Strong working knowledge of Risk Management
Must possess strong skill set to create charts and graphs using Excel
Excellent written and oral communication skills
Proficient computer knowledge, including Microsoft Word, Excel and PowerPoint
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Ability to successfully manage without authority in a cross-functional matrixed environment
Ability to communicate in a proactive and 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

Base Annual Salary Range: $104,130 - $143,179

Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness.  EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

At Bachem, you’ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.

About the Company

Bachem

Develops and manufactures peptides and oligonucleotides

Bachem provides development and manufacturing of peptides and oligonucleotides for research, clinical development, and commercial products. Its offerings include custom synthesis and scale-up production, analytical testing, and related services across the drug development spectrum. Customers work with Bachem by specifying desired sequences and specifications, after which Bachem designs, synthesizes, and quality-controls the peptides or oligonucleotides and delivers them in appropriate scales and formats. The company differentiates itself through more than five decades of experience, a global footprint with sites in Europe, the US, and Asia, and an integrated set of services spanning discovery support to commercial manufacturing. Its goal is to help pharmaceutical and biotechnology companies advance peptide- and oligonucleotide-based therapies by providing reliable, scalable, and well-supported manufacturing and development capabilities.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Bubendorf, Switzerland
Founded: 1971

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