Quality Director; Quality Assurance and Analytical Service Operations M​/F​/D

Job Family / Sub-family

Quality & Regulatory - Global Quality

Quality Director (Quality Assurance and Analytical Service Operations) M/F/D

Permanent

Quality Director (Quality Assurance and Analytical Service Operations) M/F/D

The Quality Director, Quality Assurance and Analytical Service Operations will provide strategic, managerial, and technical leadership to both quality assurance and analytical development/QC teams. This role is responsible for building, mentoring, and leading a high-performing team of scientists and quality professionals, fostering a collaborative and innovative work culture that aligns with site business objectives and to deliver first class services to customers.

• Strategic Leadership & Project Management:
• Develop and execute the overall QA strategy aligned with company goals and site business needs.
• Develop and implement phase-appropriate, modality (mostly small molecules and functional polymers) specific quality guidelines and analytical/QC strategies across numerous client projects, ensuring alignment with project timelines, budgets, and specific client requirements.
• Client & Business Development Support:
• Represent senior site leadership serving as the primary quality and analytical technical lead for clients, ensuring seamless communication and alignment of project goals.
• Collaborate with the business development team to evaluate and assess new client projects, contributing to proposals and technical discussions to secure new business.
• Regulatory Compliance:
• Ensure all quality operations and procedures adhere to global health authorities’ regulations and standards (ICH, FDA, EMA, cGMP/GLP) and corporate guidelines.
• Represent site and serve as a subject matter expert (SME) during client audits and health authority inspections.
• Team Management & Development:
• Lead, mentor, and build a high-performing, multi-function team of scientists and quality professional, fostering a collaborative and innovative work culture focused on client success and scientific excellence.
• Operational Excellence - quality:
• Establish and continuously improve the Quality Management System (QMS).
• Identify quality risks and implement mitigation strategies.
• Oversee batch record/data review and production releases based on defined criteria.
• Drive root-cause analysis (RCA) and corrective/preventive actions (CAPA).
• Operation Excellence - analytical development and QC:
• Oversee the development, transferring, qualification, and validation of robust analytical methods (e.g., HPLC, GC, LC-MS, GC-MS, IC, and GPC-MALS, etc.) for release, stability, and characterization testing for drug substances and functional excipients.
• Providing expert scientific guidance in troubleshooting & investigations.
• Operation Excellence - technology:
• Strategic planning and forecasting on capital investment in quality and analytical technologies aligns with business growth.
• Implement and enforce industry best practices and drive adoption of modern tools and frameworks in analytical development/QC fields.

• An advanced degree (Ph.D. preferred, or M.S. with equivalent experience) in Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
• 15+ years of pharmaceutical quality/analytical development experiences with minimum of 5+ years in official managerial role in quality functions and/or analytical development/QC team within the pharmaceutical, biopharmaceutical and medical device industries, with significant focusing on a cGMP production environment.
• Working knowledge of regulatory guidelines and standards (ICH, FDA, EMA, cGMP/GLP). In-depth knowledge of global regulatory requirements in API, functional excipients (polymer), and medical devices. Experiences of supporting successful regulatory submissions (IND, NDA, BLA) is a plus.
• Deep expertise in advanced pharmaceutical and biopharmaceutical manufacturing and testing techniques, preferably in small molecule and functional polymers. Experiences of defining, developing, and defending analytical control strategies in API and functional excipients manufacturing from preclinical phase to commercial stages.
• Strong project management, strategic thinking, and the ability to manage multiple priorities in a dynamic, fast-paced environment.
• Excellent interpersonal and client-facing communication skills, with the ability to convey complex technical information clearly and concisely.
• Proven track record of increased responsibility of high-performance team building, mentoring, and developing of team members of all levels.

USA, Massachusetts, Devens