Senior Quality Control Manager - GMP Lab & Validation

Bachem; Vista (CA); On-site; USD 109,396 - 183,293; Full time

Benefits offered by this job

Competitive pay

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Job summary

Bachem Americas is seeking a Manager/Sr. Manager, Quality Control to lead QC testing across IPC, API, raw materials, and stability programs. You will supervise QC Scientists, train staff, and ensure testing plans align with manufacturing schedules.

The role emphasizes developing analytical methods, maintaining specifications, and driving GMP compliance while coordinating external labs and CAPA actions as needed.

Qualifications

• Bachelor's degree in a relevant scientific field with 8+ years' industry experience.
• Master's degree preferred with 5+ years' industry experience.
• PhD in a relevant field with 2+ years' industry experience preferred.
• 1-3 years’ management experience preferred.
• 1-3 years’ project management experience preferred.
• Extensive GMP lab testing experience (IPC, HPLC, GC, TLC, UV-Vis, FTIR, MS, LAL, bioburden).
• Strong knowledge of analytical chemistry and USP testing.
• Excellent communication and computer skills.

Responsibilities

• Oversee QC testing execution including IPC, API, raw materials, validation, release, EM and microbial testing.
• Supervise QC Scientists: training, scheduling, mentoring and coaching.
• Establish and revise specifications and sampling plans for IPC, raw materials, final product.
• Develop and optimize analytical methods for qualification and release testing.
• Coordinate stability program and testing to meet stability endpoints.
• Manage IPC and raw material/API release activities to meet manufacturing deadlines.
• Draft and review QC SOPs and test methods as needed.
• Evaluate new analytical technologies and instrumentation.

Skills

Management experience

Project management

Analytical thinking

Communication skills

GMP knowledge

Education

Bachelor's degree in life sciences

Master's degree (preferred)

PhD (preferred)

Tools

HPLC

GC

TLC

UV-Vis

FTIR

MS

Karl Fischer

Job description

Bachem Americas is seeking a Manager/Sr. Manager, Quality Control to lead QC testing across IPC, API, raw materials, and stability programs. You will supervise QC Scientists, train staff, and ensure testing plans align with manufacturing schedules.

The role emphasizes developing analytical methods, maintaining specifications, and driving GMP compliance while coordinating external labs and CAPA actions as needed.