SEQENS · 3 days ago
Quality Director (Quality Assurance and Analytical Service Operations) M/F/D
Devens, MA
Full-time
Onsite
Director/Executive
15+ years expSEQENS is seeking a Quality Director to provide strategic, managerial, and technical leadership to quality assurance and analytical development/QC teams. The role involves building and mentoring a high-performing team, ensuring compliance with global regulations, and driving operational excellence across various projects.
BiotechnologyPharmaceutical
Responsibilities
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
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
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
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
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)
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
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
Qualification
Required
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
Company
SEQENS
Seqens is a integrated in pharmaceutical synthesis and specialty ingredients, delivering unrivalled market responsiveness.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Eurazeo
2021-12-17Acquired
2016-06-22Private Equity
2016-03-01Seed
Leadership Team
Laetitia Brun
Chief Human Resources Officer
Recent News
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2025-11-06
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