Director, Quality Assurance New Modalities, Antibody Drug Conjugate

Reporting to the AVP of New Modalities Manufacturing Division Quality, this leader is responsible for providing Antibody Drug Conjugate (ADC) expertise and supporting a quality oversight model necessary to facilitate agility and speed‑to‑market while ensuring sustained, compliant supply of specialty New Modalities pipeline products to global markets, to serve our patients. The role will leverage ADC experience to support the implementation of a fit‑for‑purpose quality management system and ensure strategic quality oversight of new modality products manufactured in our company’s network and at external partner sites. The leader will interact with cross‑divisional and functional teams from development through commercialization to ensure implementation of new quality guidance and the designed quality oversight model. Primary Responsibilities Provide quality leadership as part of the New Modalities Quality team to ensure end‑to‑end quality oversight necessary to facilitate agility and speed‑to‑market while sustaining compliant supply of new modality pipeline products. Stay ahead of current GMP requirements and industry trends as described in worldwide regulations and industry standards, and provide trend reporting. Maintain a subject‑matter expert level of knowledge related to ADC and other specialized areas. Provide guidance and coaching to manufacturing colleagues on new modality quality oversight requirements and Health Authority GMP expectations. Evaluate current company and partner Quality Management Systems for seamless integration and realisation of synergies while ensuring compliance to GMP requirements. Ensure alignment to corporate policies as well as other divisional policies related to management of product quality. Implement a fit‑for‑purpose QMS, ensuring end‑to‑end quality oversight of new modality products manufactured at our company and external partner sites. Partner with our company’s Manufacturing Division QMS team for QMS updates as needed. Work in partnership across Research, Manufacturing, and Commercial to understand the unique requirements for new modality products and ensure that these requirements are addressed via fit‑for‑purpose quality management oversight. Evaluate external partner quality and compliance robustness and identify quality risks. Work with internal colleagues and external partners to remediate risks as appropriate. Ensure that facilities/processes are compliant and support approval of new modality regulatory filings. Maintain close working relationships with research, manufacturing, and technical CMC teams for end‑to‑end quality oversight and support of new modality products. Support development of and report quality metrics measuring operational effectiveness to appropriate research and manufacturing governance forums. Ensure continuous improvement of the new modality QMS to maintain GMP and regulatory compliance. Required Qualifications Bachelor’s degree in Life Science, Engineering, or a related discipline. Minimum of ten (10) years’ experience within the pharmaceutical industry. Experience working with or directly supporting manufacture of Antibody Drug Conjugate (ADC) products. Leadership and Technical Skills People change management experience. Quality operations and/or compliance experience. Demonstrated effective leadership, communication, interpersonal and negotiating skills, particularly with cross‑functional partners. Ability to learn and understand technical aspects of new processes to ensure robust quality oversight. Preferred Qualifications Technical experience with vaccines, biologics, and/or cell gene therapy products. Experience in both Quality Assurance and Quality Control. Experience interacting with regulators. Advanced degree in Life Sciences, Engineering, or a related discipline. Salary range: $173,200.00 – $272,600.00. We offer a comprehensive benefits package, including medical, dental, vision, insurance, retirement benefits such as 401(k), paid holidays, vacation, and sick days. Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit EEOC resources. We are committed to inclusion and welcome applicants from diverse backgrounds. US and Puerto Rico residents only. We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance and will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local laws, including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance. #J-18808-Ljbffr Merck & Co.