Director, Quality Assurance Modalities, Antibody Drug Conjugate

Job Description

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. This leader will leverage ADC experience to support the implementation of a fit‑for‑purpose quality management system and ensure strategic quality oversight of new modalities products manufactured in our company's network and at external partner sites.

The leader will interact with our company's cross‑divisional/functional teams from development through commercialization to ensure implementation of new quality guidance and the designed quality oversight model. Activities will include implementation of required Quality Management System (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current Good Manufacturing Practices (cGMPs), other worldwide regulations and our company's requirements.

• 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 modalities pipeline products to global markets.
• Stay ahead of current GMP requirements and industry trends as described in worldwide regulations and industry standards, and trend reporting.
• Maintain a subject‑matter expert level of knowledge related to these specialized areas of expertise, with a specific focus on Antibody Drug Conjugates.
• Provide guidance and coaching to manufacturing colleagues on new modalities quality oversight requirements and Health Authority GMP expectations.
• Evaluate current company and partner Quality Management Systems for seamless integration and realize synergies where available 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 modalities 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 the organization (Research, Manufacturing and Commercial) to understand the unique requirements for the 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 relationship with our research and manufacturing divisions' Quality departments and Technical CMC teams for end‑to‑end Quality oversight/support of new modalities products.
• Support development of and report quality metrics measuring operational effectiveness to appropriate research and manufacturing divisions' governance forums.
• Ensure continuous improvement to new modalities QMS to maintain GMP and Regulatory compliance.

• Bachelor's degree in Life Science Field, Engineering field or a related relevant discipline.
• Minimum of ten (10) years’ experience within the pharmaceutical industry.
• Experience working with or directly supporting manufacture of Antibody Drug Conjugate (ADC) products.

• People change management experience
• Quality operations and/or compliance experience
• Demonstrated effective leadership, communication, interpersonal and negotiating skills, in particular with cross functional partners
• Ability to learn and understand technical aspects of new processes to ensure robust Quality oversight

• Technical experience with vaccines, biologics, and / or cell gene therapy products
• Experience in both Quality Assurance and Quality control
• Experienced in interacting with regulators.
• Advanced degree…