Associate Director - Quality Assurance

4 days ago

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Description

• The Associate Director, Quality Assurance provides GxP quality/compliance support and oversight of the quality system. • Leads critical Quality Assurance GMP tasks relating to Small and/or Large Molecule Drug Substance and Drug Product activities/projects. • Reviews and approves GxP related documents, as requested.

Requirements

• Bachelor’s degree in related Life Sciences discipline such as Chemistry, Biology, or Chemical Engineering. • Master’s degree preferred. • Minimum 8 years of experience in Biotech or Pharmaceutical industry in QA or a related field. • Minimum of 5 years of Quality Assurance auditing experience preferred. • In-depth knowledge of and ability to interpret and apply GxP, FDA and ICH regulations and guidelines. • Proven ability in driving GxP process improvement initiatives. • Strong professional experience in a similar role within the pharmaceutical industry, both small and large molecule pharmaceuticals. • Ability to travel 20-30% domestic and internationally.

Benefits

• Premium health, financial, work-life and well-being offerings for eligible employees and dependents. • Wellness and employee support programs. • Life insurance. • Disability. • Retirement plans with employer match. • Generous paid time off.

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