Associate Director, Quality Assurance (Drug Substance/Drug Product)

Accountabilities:

• • Provide GxP quality oversight and guidance to cross-functional teams throughout late-stage development, commercial manufacturing, and the broader drug lifecycle.
  • Ensure manufacturing programs comply with applicable global GxP regulations, including GMP, GCP, GLP, and GVP requirements, as relevant.
  • Serve as a primary Quality Assurance point of contact for contract manufacturing organizations (CMOs), external manufacturing sites, contract laboratories, and suppliers.
  • Assess CMO quality systems, processes, specifications, and SOPs to ensure they support compliant clinical and commercial manufacturing, product release, and distribution.
  • Review and approve vendor master records, executed batch records, stability protocols, validation protocols and reports, analytical methods, protocols, and related documentation.
  • Conduct or support product release activities for drug substance, drug product, packaged product, and labeled product.
  • Evaluate, escalate, and resolve product quality issues, ensuring appropriate follow-up and timely closure.
  • Lead quality activities associated with internal and external change controls, including assessment of product quality and regulatory impact.
  • Review and approve deviations, complaints, investigations, OOS/OOT events, and related CAPAs while partnering with stakeholders to drive timely and effective resolution.
  • Review data and documentation to verify compliance with data integrity principles and applicable regulatory requirements.
  • Support CMC regulatory submissions by reviewing and approving relevant documentation and responding to Health Authority information requests as needed.
  • Track, trend, and report manufacturing quality compliance metrics for Quality Management Team reporting.
  • Support Good Distribution Practice requirements in the EU in collaboration with the designated responsible personnel.
  • Develop, review, and approve GxP-controlled documents, including policies, SOPs, work instructions, and supporting quality documentation.
  • Provide phase-appropriate oversight of quality systems and help optimize them as programs transition from clinical development into commercial operations.
  • Coordinate and conduct routine and non-routine quality audits covering CROs, vendors, processes, systems, and documentation.
  • Participate in internal audits, identify improvement opportunities, and collaborate with stakeholders to implement sustainable corrective actions.
  • Support preparation for regulatory authority inspections and participate in interactions during inspections as required.
  • Continuously improve and maintain quality systems and documentation to support ongoing regulatory and GxP compliance.

  Requirements:

  • Bachelor’s degree in a scientific discipline required; an advanced scientific or related degree is a plus.
  • 6–8 years of experience in the pharmaceutical industry, including at least 6 years working in Quality Assurance or a closely related quality function.
  • Strong understanding of domestic and international GxP standards, regulations, policies, and procedures.
  • Demonstrated experience with small-molecule drug substance manufacturing and non-sterile oral solid dosage drug product manufacturing.
  • Experience working with contract manufacturing organizations and external vendors.
  • Experience conducting or supporting GMP vendor audits is strongly preferred.
  • Commercial launch and post-launch product experience is preferred.
  • Strong knowledge of quality systems, deviations, CAPAs, change controls, investigations, batch records, validation, and product release processes.
  • Excellent written and verbal communication skills, with the ability to communicate effectively across technical and non-technical stakeholder groups.
  • Strong analytical and problem-solving abilities, with the judgment to evaluate complex quality issues and develop practical, risk-based recommendations.
  • Highly collaborative approach with the ability to influence cross-functional teams and external partners.
  • Self-directed and adaptable, with the ability to manage competing priorities and work independently with minimal supervision.
  • Strong attention to detail and commitment to maintaining rigorous quality and compliance standards.
  • Comfortable working in a fast-paced environment where priorities can shift based on program and regulatory needs.
  • Ability to travel domestically and internationally approximately 20% of the time.

  Benefits:

  • Competitive base salary.
  • Annual performance bonus.
  • Long-term incentive opportunities.
  • Comprehensive health insurance coverage.
  • Dental insurance.
  • Vision insurance.
  • Term life insurance.
  • Disability coverage.
  • Retirement plan options.
  • Fully remote position within the United States.
  • Opportunity to contribute to late-stage and commercial pharmaceutical programs with significant quality and regulatory impact.
  • Collaborative environment with cross-functional exposure to manufacturing, regulatory, quality, and external partners.
  • Opportunity to influence and continuously improve GxP quality systems as programs transition from development to commercial operations.