Senior Product Quality Leader — API Lifecycle & Compliance

Bachem Holding AG; Vista (CA); On-site; USD 104,000 - 143,000; Full time

Benefits offered by this job

Competitive pay

Performance bonus

Medical/Dental/Vision coverage

401(k) plan

Job summary

Bachem Americas is seeking a Sr. Product Quality Manager to serve as the Quality representative from development through commercialization.

You will lead strategic quality oversight across the product lifecycle and act as the primary interface with clients, audits, and regulatory bodies. The role focuses on risk assessments, control strategies, and lifecycle initiatives, collaborating with Manufacturing, Tech Ops, Engineering, and QC to ensure compliant, scientifically sound processes and

Qualifications

• Bachelor-level science degree required.
• Master's degree in science preferred.
• 10–15 years GMP experience required.
• 8+ years peptide/API manufacturing experience preferred.
• Strong ability to assess SOPs, investigations and protocols for compliance.

Responsibilities

• Lead lifecycle management and act as Quality representative across development to commercialization.
• Serve as Voice of Quality on project teams; liaison with external clients.
• Review and approve Technology Transfer Plans and Reports; support transfer activities.
• Oversee validation, CPV plans, cleaning validation and method validation activities.
• Support CPV programs; review process performance data and quality trends.
• Participate in Quality Risk Management; support development of CPPs, CQAs and control strategies.
• Provide oversight for raw material, in-process, intermediate and API release specifications; support lifecycle strategy.

Skills

Quality leadership

cGMP knowledge

Risk management

Cross-functional collaboration

Regulatory inspections

Analytical thinking

Regulatory submissions

Data analysis (Excel)

Communication skills

Project governance

Education

Bachelor's Degree in a Science related field

Master's Degree in a Science related field (preferred)

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Bachem Americas is seeking a Sr. Product Quality Manager to serve as the Quality representative from development through commercialization.

You will lead strategic quality oversight across the product lifecycle and act as the primary interface with clients, audits, and regulatory bodies. The role focuses on risk assessments, control strategies, and lifecycle initiatives, collaborating with Manufacturing, Tech Ops, Engineering, and QC to ensure compliant, scientifically sound processes and