Senior Manager/Associate Director, Quality Control

Job summary

The Senior Manager/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 analytical results, stability programs, reference standards, and leading investigations for out-of-specification or out-of-trend observations.

Job details

The Senior Manager/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 analytical results, stability programs, reference standards, and leading investigations for out-of-specification or out-of-trend observations. Candidates must hold an undergraduate degree in life sciences and possess at least 5 to 8 years of relevant management experience in the pharmaceutical industry. Strong expertise in quality control, stability programs, and regulatory CMC submissions is required, along with excellent communication and leadership skills.

What you’ll do

The Senior Manager/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 analytical results, stability programs, reference standards, and leading investigations for out-of-specification or out-of-trend observations.

Requirements

Candidates must hold an undergraduate degree in life sciences and possess at least 5 to 8 years of relevant management experience in the pharmaceutical industry. Strong expertise in quality control, stability programs, and regulatory CMC submissions is required, along with excellent communication and leadership skills.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Short-term disability
• Long-term disability
• Accidental death and 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 and 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
• cGMP
• ICH guidelines
• Analytical testing
• Stability program management
• Regulatory submissions
• OOS investigations
• OOT investigations
• Method validation
• Batch release
• Quality management systems
• CMC
• Small molecules
• Team leadership
• Auditing
• Technical writing

Job areas

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

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