This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Quality Assurance (Drug Substance/Drug Product) based in the United States.
As an Associate Director, Quality Assurance, you’ll help oversee end-to-end GxP quality activities across drug substance and drug product manufacturing programs. You’ll provide hands-on quality leadership across late-stage development, commercial manufacturing, and product lifecycle activities. The role requires close collaboration with internal teams, contract manufacturers, laboratories, suppliers, and regulatory stakeholders. You’ll ensure quality systems, controlled documentation, manufacturing processes, and product releases remain compliant with global requirements and industry standards. You’ll also play a key role in investigations, audits, change controls, CAPAs, and regulatory submissions. This is a highly collaborative, fast-paced environment suited to a quality professional who can work independently while driving complex issues toward practical resolution.
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.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
#LI-CL1
