Associate Quality Assurance Manager/Quality Assurance Manager

Bachem AG•Vista, CA

1d•$77,912 - $132,925

About The Position

The Associate Quality Assurance Manager or Quality Assurance 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 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 independent product ownership, serving as the Product Quality lead for assigned products and independently interfacing with clients. The role leads product-level quality initiatives, facilitates risk assessments and cross-functional decision-making, supports commercial readiness activities, and contributes to the ongoing advancement of product quality and lifecycle management.

Requirements

Bachelor's Degree in a Science related field required
8-10 years GMP experience required
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 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

Nice To Haves

Master's Degree preferred
5+ years peptide/API manufacturing experience preferred

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.
Support annual product reviews and ongoing product quality evaluations.
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.
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.
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 opportunities for process improvement.
Support investigation of adverse process trends and implementation of preventive actions.
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.
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.
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.