Associate Director, Quality Control

Job summary

The Associate Director will lead quality control activities for clinical and commercial drug substance and drug product programs, ensuring compliance with ICH and cGMP requirements. Responsibilities include managing stability programs, overseeing analytical testing, leading investigations for OOS/OOT results, and managing relationships with external testing laboratories.

Job details

The Associate Director will lead quality control activities for clinical and commercial drug substance and drug product programs, ensuring compliance with ICH and cGMP requirements. Responsibilities include managing stability programs, overseeing analytical testing, leading investigations for OOS/OOT results, and managing relationships with external testing laboratories. Candidates must possess an undergraduate degree in life sciences and at least 8 years of relevant management experience in the pharmaceutical industry. Strong expertise in quality control, stability programs, regulatory CMC submissions, and cGMP environments is required.

What you’ll do

The Associate Director will lead quality control activities for clinical and commercial drug substance and drug product programs, ensuring compliance with ICH and cGMP requirements. Responsibilities include managing stability programs, overseeing analytical testing, leading investigations for OOS/OOT results, and managing relationships with external testing laboratories.

Requirements

Candidates must possess an undergraduate degree in life sciences and at least 8 years of relevant management experience in the pharmaceutical industry. Strong expertise in quality control, stability programs, regulatory CMC submissions, and cGMP environments is required.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Short-term disability
• Long-term disability
• Accidental death & dismemberment insurance
• Life insurance
• Employee assistance program
• Travel insurance
• Retirement savings program
• Company matching contributions
• Vacation
• Personal days
• Sick days
• End-of-year company shutdown
• Training, learning & development program
• Tuition assistance program
• Stock options
• Target bonus

Listed skills

• Quality Control · Preferred
• Team Leadership · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Quality control
• Small molecule drug development
• Stability program management
• ICH guidelines
• cGMP compliance
• Analytical testing
• Regulatory submissions
• IND
• NDA
• CTA
• OOS/OOT investigations
• Method validation
• Team leadership
• Vendor management
• CMC
• Quality management systems

Job areas

• Science & Research
• Healthcare
• Management & Leadership
• Manufacturing

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