Sr. Quality Control Manager

Bachem; Vista (CA); On-site; USD 133,000 - 183,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation, personal and sick days

Job summary

Bachem, a leading API manufacturer, seeks a Sr. Manager to lead Quality Control activities in Vista, CA. You will oversee QC testing, regulatory compliance, and a team of QC scientists, while coordinating internal and external labs to ensure strict release criteria are met.

You will drive method development, stability programs, CAPA execution, and SOP creation, contributing to overall QC capabilities and performance within a fast-paced, GMP environment.

Qualifications

• Bachelor's degree in a scientific field with 12+ years of experience.
• Master's degree with 9+ years of experience (preferred).
• PhD with 6+ years of experience (preferred).
• 4+ years management experience.
• 1-3 years project management experience (preferred).
• Extensive GMP lab testing experience (IPC, HPLC, GC, TLC, UV-VIS, FTIR, MS, LAL).
• Strong analytical chemistry knowledge including USP testing.
• Excellent communication and problem-solving skills.

Responsibilities

• Oversee QC testing including IPC, API, raw materials, validation and release.
• Supervise QC scientists with training, scheduling, mentoring and coaching.
• Set specifications and sampling plans for IPC, materials and final product.
• Develop and optimize analytical methods for qualification and release testing.
• Coordinate stability program and testing to meet endpoints.
• Manage release activities to align with manufacturing schedules.
• Write, review and approve QC SOPs as needed.
• Evaluate new analytical technologies and instrumentation for testing.
• Investigate OOS results, write reports and implement CAPAs.
• Manage external contract labs for testing and data review.
• Provide timely responses to inquiries and stay updated on innovations.
• Contribute to GMP improvements and laboratory efficiency.

Skills

Communication skills

Project management

Analytical thinking

Team leadership

Education

Bachelor's degree in a scientific field

Master's degree in a scientific field

PhD in a scientific field

Tools

Microsoft Word

Excel

PowerPoint

Access

Job description

The Sr. Manager, Quality Control fulfills a critical role in the active pharmaceutical ingredient (API) manufacturing operations. This individual is responsible for managing and coordinating stability testing, raw material qualification, testing and release, and validation projects. The Manager / Sr. Manager coordinates both in-house and contract laboratory testing activities. Additionally, this individual supports the Director, Quality Control in reviewing data and reports. This role also serves to advance analytical capabilities and contributes to the development of the Quality Control department.

What you will do

• Manage and oversee execution of QC testing including IPC, API, raw material, validation, release, EM and microbial testing
• Supervise QC Scientists. Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel
• Establish and revise specifications and sampling plans for IPC, raw materials and final product
• Develop and optimize new and existing analytical methods for qualification and release testing
• Coordinate stability program and the testing to meet stability endpoints, as needed
• Manage IPC release activities, raw material and API release activities to meet deadlines tied to manufacturing schedules
• Write, review, and approve QC Standard Operating procedures (SOP’s) as needed
• Evaluate, recommend, and implement new analytical technologies and instrumentation for raw material, final product, In process, microbial, environmental, and water testing
• Investigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent recurrences
• Manage external test laboratories for contract testing of raw materials and other related testing
• Review test data for completeness and accuracy
• Provide timely responses to internal and external inquiries
• Stay abreast of new developments in analytical technologies
• Contribute to improvements in laboratory operations to increase efficiency and GMP compliance

Qualifications

• Bachelor's degree in a relevant scientific field with a minimum of 12 years’ industry experience
• Master's degree in a relevant scientific field with a minimum of 9 years’ industry experience (preferred)
• PhD in a relevant scientific field with a minimum of 6 years’ industry experience (preferred)
• 4+ years’ management experience
• 1-3 years’ experience in managing projects (preferred)
• Extensive experience in GMP laboratory testing such as IPC, HPLC, GC, TLC, UV-VIS Spectrophotometer, Karl Fisher Titrator, FTIR, MS, LAL, bioburden, etc.
• Thorough knowledge and understanding of analytical chemistry, including USP materials testing
• Creativity to solve technical and compliance problems
• Comply with good housekeeping and safety practices
• Experience in writing standard operating procedures (SOP’s) and test methods
• Excellent written and oral communication skills
• Excellent computer knowledge, including Microsoft Word, Excel, Power Point and Access
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work 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 problems
• Ability to work independently and manage one’s time
• Ability to drive projects to success under time constraints
• Communicate effectively and ability to function well in a team environment

Base salary range:

Sr. Manager: $133,304 - $183,293

Placement of new hires in these wage ranges 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.