Director – Quality GMP Small Molecules

• Oversight of the external quality activities for DS and DP associated with development, manufacturing, disposition, analytics, and distribution of clinical materials.
• Primary GMP/GDP Quality contact for identified vendors supporting clinical programs.
• Execute quality activities (including working with Qualified Person) to ensure materials are released in accordance with regulatory requirements, cGMPs, as well as procedures and are within project lead times.
• Author key GMP/GDP Quality SOPs and key reviewer for other quality (GxP) procedures. (only changed placement, moved bullet lower)
• Perform quality review of documents related to (but not only to) CMC activities at external vendors such as master batch records, analytical methods, validation protocols & reports lot release data packets, stability protocols and reports, etc. for CMC programs and regulatory submissions.
• Develop and provide cGMP and other GxP training (as applicable).
• Partner with CMC on quality events workflow by reviewing, assessing, approving, tracking quality events such as GMP/GDP related change controls, deviations, investigations, CAPA, risk management, complaints, etc.
• Ensure appropriate qualification of vendors and ensure compliant vendor management and regular assessment/audits, including participation in site visits (as applicable).
• Partner with CMC to ensure appropriate vendor/supplier oversight relating to the QMS and QTA/QAA compliance.
• Lead and participate in inspection readiness activities for regulatory inspections – both internally and at vendor sites. (This will be a key part of our shift from development to Phase II/III. Let me know if it should be in qualifications instead?)
• Be a key team player as part of an enlarged cross functional team composed of internal (CMC project leads, operations, logistics, clinics) and external members (DS and DP specific vendors) from preclinical to clinical stage Qualifications:
• Degree in Chemistry, Pharmacy, Biology or a related life science, plus required pharmaceutical or biopharmaceutical industry experience required in conjunction with degree:, BS 20+ years, MS 20+ years, PhD 15+ years.
• Preferred experience with small molecules development and exposure to commercial operations
• Proficient in GMP standards and regulatory expectation
• Experience in analytical development and/or quality control in early/mid phase small molecules development (drug substance, drug product, or both).
• Hands-on experience and knowledge of clinical (early, mid-phase) and commercial systems supporting GMP and GDP compliance with US and global regulations (FDA, EMA, MHRA, SwissMedic, ICH, etc.). GLP experience a plus.
• Hands-on leader, able to provide solution-minded, phased-appropriate approach and flexibility to emerging challenges
• Proven experience with the desire, and ability to work in a fast-paced, matrixed, start-up environment.
• Strong collaboration and team-working, communication, and organizational skills required.
• Strong problem-solving, critical thinking, and analytical skills necessary
• Able to appropriately balance priorities plus multi-task against competing priorities.
• Ability to travel to meet program needs (as applicable) – up to 15%.

Monte Rosa Therapeutics, Inc