Director, Quality Assurance – New Modalities, Antibody Drug Conjugate

Role Overview

• 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

Requirements

• 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

Benefits

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days