Merck Gruppe - MSD Sharp & Dohme | Director, Quality ...

Job Description Description: Reporting to the AVP of New Modalities in our company's Manufacturing Division Quality, this leader is responsible for supporting the implementation of a unique 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. This leader will support the implementation, including change management actions, of the organization to support 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 cross-divisional/functional teams from development through commercialization to ensure implementation of 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. Primary Responsibilities: Provide personalized therapy subject matter expertise to the New Modalities Quality team. Provide Quality leadership as part of the new Quality Platform 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. Evaluate current our company's 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. Support establishment of New Modalities Global Quality Management processes and Regulatory Compliance plan in support of early-stage development to commercialization of New Modalities products. Work in partnership across our company's organization 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 company/Manufacturing Division Quality departments and our company/Manufacturing Division 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 our company/Manufacturing Division governance forums. Ensure continuous improvement to New Modalities QMS to maintain GMP and Regulatory compliance. 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 personalized therapies. Provide guidance and coaching to our Manufacturing Division colleagues on New Modalities quality oversight requirements and Health Authority GMP expectations. Required: Bachelor's degree in Life Science Field, Engineering field, or a related relevant discipline. Minimum of ten (10) years' experience within the pharmaceutical industry. Direct experience in manufacture of or quality/technical support to manufacture of personalized medicines/cell gene therapy products or similar. Required Leadership and Technical Skills: People change management experience. Technical experience with vaccines, biologics, and/or cell gene therapy products. Technical Operations, 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. Preferred: Experience in both Quality Assurance and Quality Control. Experience in external manufacturing/external quality assurance or alliance management. Experienced in interacting with regulators. Advanced degree in Life Sciences field, Engineering field, or a related relevant discipline. #J-18808-Ljbffr

Created: 2024-11-25