Director – Quality GMP Small Molecules

Director – Quality GMP Small Molecules

Location: Basel , Switzerland

We are currently seeking a Director, Quality GMP to join our growing organization. This is an exciting opportunity to contribute to innovative science while helping to build and shape a best-in-class Quality function.

The Director, Quality GMP will provide strategic and hands-on leadership for all GMP and GDP quality aspects related to the external manufacture and supply of drug substance and drug product for Monte Rosa's molecular glue degrader (MGD) programs. This role is responsible for ensuring compliance and phase-appropriate quality oversight for our pre-clinical and clinical-stage programs.

The ideal candidate will bring deep quality expertise and thrive in a collaborative, cross-functional, and fast-paced biotech environment. You will work closely with internal teams and external partners to ensure the highest standards of quality and regulatory compliance across manufacturing, testing, and distribution activities. It is an excellent time to join the excitement at Monte Rosa and be part of a strong and effective team.

Responsibilities:

• 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.
• 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.
• 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.
• 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, Quality or a related life science, plus 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/GDP 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%.

Interested Candidates may forward a CV and Cover Letter in a single PDF via our on-line portal

Monte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases in the areas of oncology, autoimmune and inflammatory diseases, and more. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa's QuEEN (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity. Monte Rosa has developed the industry's leading pipeline of MGDs, which spans autoimmune and inflammatory diseases, oncology, and beyond. Monte Rosa has a global license agreement with Novartis to advance VAV1-directed molecular glue degraders and a strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug. For more information, visit