Associate Director, Product Quality

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, Product Quality based in the United States. We are seeking an experienced pharmaceutical quality leader to build, strengthen, and oversee quality systems supporting the development of innovative medicines. In this strategic and hands-on role, you will ensure compliance with GxP regulations while supporting product development, clinical manufacturing, and future commercialization activities. You will lead the implementation of a scalable Quality Management System (QMS) and provide quality oversight across internal operations and external manufacturing and research partners. Working closely with cross-functional teams, you will contribute to regulatory submissions, technology transfers, process validation, and product release activities. This opportunity offers the chance to shape quality strategy within a dynamic, collaborative, and fast-paced biotechnology environment. You will also mentor quality professionals, foster a culture of accountability, and help advance a promising pipeline of treatments with the potential to improve patients’ lives. Accountabilities - Design, implement, and continuously improve a scalable Quality Management System aligned with the organization's development stage, product pipeline, and regulatory obligations. - Provide GxP quality oversight across internal functions and external partners, including Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and testing laboratories. - Lead core quality processes, including deviation management, Corrective and Preventive Actions (CAPAs), change control, document control, and employee training. - Oversee quality activities supporting regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and New Drug Applications (NDAs), as well as clinical trial material release and validation programs. - Partner with technical operations and development teams on Chemistry, Manufacturing, and Controls (CMC) activities, technology transfers, manufacturing scale-up, and process readiness.

- Oversee batch record reviews, product release decisions, and quality assessments of analytical and manufacturing documentation. - Coordinate regulatory inspection readiness and third-party audits, serving as a key quality representative in interactions with health authorities. - Recruit, develop, and lead a small team of Quality Assurance professionals, promoting strong cross-functional relationships, accountability, and a culture of quality. - Support additional quality and compliance initiatives as business needs evolve. Requirements - Bachelor's degree or higher in Life Sciences, Chemistry, Pharmacy, or a related scientific discipline. - At least 8 years of experience in pharmaceutical quality roles, including 3 or more years in a leadership position. - Strong knowledge of GxP regulations and guidelines, including applicable FDA, EMA, and ICH requirements, with experience applying quality standards throughout the product lifecycle. - Hands-on experience with document control and quality management systems, such as ZenQMS, Veeva Vault, or MasterControl. - Familiarity with multiple pharmaceutical dosage forms and manufacturing models involving external CDMOs. - Demonstrated ability to establish and improve quality systems while balancing regulatory compliance, operational efficiency, and business priorities. - Strong leadership, communication, organizational, and cross-functional collaboration skills, with the ability to influence stakeholders and build effective partnerships. - Ability to work independently and strategically in a fast-paced, resource-constrained environment while remaining comfortable with hands-on execution.