Product Quality Director

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Product Quality Director based in United States. This is a senior product quality leadership role supporting late-stage and commercial pharmaceutical programs in a highly regulated environment. You will serve as a technical and strategic quality leader, guiding complex product quality activities across development, manufacturing, regulatory, and international teams. The role has broad ownership across areas such as comparability, specifications, stability, investigations, change control, and regulatory submissions. You will lead a Product Quality Team while providing scientific oversight and mentoring quality professionals. Success requires strong scientific judgment, risk-based decision-making, and the ability to translate complex technical information into effective strategies. You’ll operate at the intersection of research, global development, and manufacturing, helping advance products from development through commercial lifecycle management.

Provide cross-functional Product Quality leadership for multiple complex, long-term deliverables supporting late-phase and commercial programs, including product quality team activities, annual product reviews, specification and stability programs, comparability assessments, site and analytical method transfers, and regulatory commitments. Lead and provide scientific oversight for product quality activities supporting pivotal and commercial products, including timely review of product data, GMP documentation, regulatory filing sections, quality system transactions, and responses to regulatory questions and inspections. Lead a Product Quality Team and provide oversight of product stability programs while offering guidance, mentorship, and indirect management support to team members. Apply science- and risk-based approaches to complex process and product quality data, developing patient-focused strategies that address business needs and provide effective solutions to challenging technical issues. Collaborate with Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional organizations to resolve issues related to manufacturing processes, analytical methods, specifications, investigations, change controls, and product quality. Communicate complex scientific, technical, and quality information effectively to senior leadership, peers, cross-functional stakeholders, and regulatory agencies, including during inspection-related activities. Monitor emerging scientific and technical developments and assess their potential implications for product quality, regulatory compliance, and operational practices. Drive operationally efficient quality processes and alignment across international sites while mentoring team members and strengthening Product Quality capabilities. Requirements: Hold a Doctorate degree with at least 4 years of experience in Quality, Operations, Scientific, or Manufacturing functions, or a Master’s degree with at least 7 years of relevant experience, or a Bachelor’s degree with at least 9 years of relevant experience. An advanced degree in chemistry, biochemistry, biology, or a related biotechnology science field is preferred, along with strong expertise in protein and small molecule analysis and applicable industry regulations. Bring 8+ years of pharmaceutical industry experience with increasing responsibility across quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environments. Have at least 6 years of direct experience working in a regulated GMP environment, with a strong understanding of international regulatory expectations and pharmaceutical quality requirements. Demonstrate at least 5 years of experience managing staff, ideally with progressively broader responsibility for larger teams, and previous experience as a Product Quality Leader, technical professional, or product champion. Bring experience authoring or reviewing regulatory filings and related documentation, as well as supporting non-conformance investigations involving critical product-impacting issues. Demonstrate project management experience supporting product development, together with knowledge of drug substance and drug product development and manufacturing. Have strong knowledge of protein and small molecule quality, compliance, regulatory requirements, and analytical techniques used for protein product quality control. Demonstrate strong leadership, people management, communication, facilitation, and presentation skills, with the ability to influence effectively within a cross-functional matrix organization. Be comfortable working collaboratively across international and multidisciplinary teams while applying sound judgment, technical expertise, and a patient-focused approach to complex quality decisions. Benefits: Annual base salary range of $176,370.75–$238,619.25 USD. Comprehensive employee benefits, including medical, dental, and vision coverage for eligible employees and dependents. Retirement and Savings Plan with generous employer contributions. Life and disability insurance and flexible spending account options. Eligibility for a discretionary annual bonus program. Stock-based long-term incentive opportunities. Award-winning paid time-off programs. Flexible work models where applicable to the role and work location. Opportunities for professional development and career growth within a collaborative, science-driven environment. Work/life balance support and financial programs designed to support long-term personal and professional well-being. Sponsorship for this role is not guaranteed.

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