Director of Quality Control

Bachem; Torrance (CA); On-site; USD 149,000 - 206,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Director of Quality Control in Torrance, CA. This role involves leading quality control and analytical functions, ensuring compliance with regulatory standards, and managing a team. Ideal candidates will have significant experience in GMP manufacturing and a strong educational background in chemistry or chemical engineering. The position offers a competitive salary and comprehensive benefits.

Benefits

Medical insurance

Vision insurance

401(k) with employer contribution

Paid vacation

Paid maternity leave

Paid paternity leave

Student loan assistance

Qualifications

• Minimum 5 years’ experience in GMP manufacturing for Master's degree holders.
• At least 4 years management experience in a leadership role.

Responsibilities

• Lead Quality Control and Analytical functions for compliance with FDA regulations.
• Oversee quality control laboratories and stability programs.
• Manage and develop employees in quality control.

Skills

Leadership

Communication

Problem Solving

Detail Oriented

Time Management

Education

Master’s degree in chemistry or chemical engineering

Bachelor’s degree in chemistry or chemical engineering

PhD in Chemistry/Chemical Engineering

Tools

SAP

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

LIMS/ELN

Job description

5 days ago Be among the first 25 applicants

This range is provided by Bachem. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$149,360.00/yr - $205,370.00/yr

Additional compensation types

Annual Bonus

A brief overview

The Director of Quality Control will lead the Quality Control and Analytical functions for release, stability, raw material testing and method validation/transfer functions in compliance with FDA and other international regulatory requirements for research, pre-clinical, clinical and commercial pharmaceutical products at Bachem.

What you will do

• Maintain the quality control laboratories and stability program per FDA cGMP parts 210 and 211, ICH Q7 and Q9 requirements for drug substances and ISO 13485 for raw materials used in device and diagnostics
• Develop annual master analytical validation plan and ensure validations are conducted per ICH guidelines, including cleaning validations and analytical test method validation
• Ensure continuous improvement and effectiveness of the quality control labs
• Oversee and conduct cGMP, ICH and ISO stability programs to comply with regulatory requirements
• Oversee work of direct reports; distribute workload, and cross-train staff on different quality areas. Interview, hire, train, develop and manage employees
• Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records
• Investigate and document out-of-specification results and deviations during product testing
• Assure and oversee QC laboratory testing and documentation under cGMP conditions
• Maintain laboratory performance matrices and other activities as assigned.

Qualifications

• Master’s degree in chemistry or chemical engineering (or equivalent) with a minimum of 5 years’ work experience in GMP manufacturing
• Bachelor’s degree in chemistry or chemical engineering (or equivalent) with a minimum of 8 years’ work experience in GMP manufacturing
• PhD in Chemistry/Chemical Engineering (or equivalent) with a minimum 1 year of relevant work experience
• At least 4 years management experience including people management at a leadership role.
• Experience with peptides and oligomer manufacturing processes (preferred)
• Experience with Master Control (preferred)
• Experience with SAP (preferred)
• Knowledge of cGMP and FDA regulations
• Knowledge in Method Qualification/Validation and Analytical Transfers
• Knowledge in routine QC functions including OOS/OOT, Deviations, CAPA’s and Change Controls.
• Experience with overseeing regulatory audits (preferred)
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Familiarity with laboratory electronic systems including LIMS/ELN
• 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 complex scientific problems
• Ability to work independently and manage one’s time effective time management
• Communicate effectively and ability to function well in a team environment

Base Salary Range: $149,360 - $205,370

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 Platinum Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science, Research, and Manufacturing

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at Bachem by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Student loan assistance

Paid paternity leave

Paid maternity leave

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