Associate Director, Quality Assurance (Drug Substance/Drug Product)
New
J
JobgetherPharmaceuticals
Fully remote position within the United States.Full-TimeDirector
SalaryCompetitive base salary, annual performance bonus, and long-term incentive opportunities.
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Job Details
- Experience
- 6–8 years of experience in the pharmaceutical industry, including at least 6 years working in Quality Assurance.
- Required Skills
- Quality Assurance
Requirements
- Bachelor’s degree in a scientific discipline.
- 6–8 years of experience in the pharmaceutical industry, with at least 6 years in Quality Assurance.
- Strong understanding of domestic and international GxP standards (GMP, GCP, GLP, GVP).
- Expertise in small-molecule drug substance manufacturing.
- Experience with non-sterile oral solid dosage drug product manufacturing.
- Experience working with contract manufacturing organizations (CMOs) and external vendors.
- Proficiency in quality systems: deviations, CAPAs, change controls, investigations, and batch record reviews.
- Ability to travel domestically and internationally approximately 20% of the time.
Responsibilities
- Provide GxP quality oversight and guidance for late-stage development and commercial manufacturing.
- Act as primary QA contact for contract manufacturing organizations (CMOs), labs, and suppliers.
- Review and approve batch records, validation protocols, analytical methods, and vendor master records.
- Lead quality activities for change controls, deviations, investigations, and CAPAs.
- Conduct or support product release for drug substance and drug products.
- Perform vendor audits and support regulatory authority inspections.
- Maintain GxP documentation and quality systems through the product lifecycle.
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