Director - Quality Gmp Small Molecules
Vor 6 Tagen
Overview:
**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. (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%.
-
Director – Quality GMP Small Molecules
vor 3 Wochen
Basel, Schweiz Monte Rosa Therapeutics Inc. VollzeitOverview Monte Rosa Therapeutics is seeking a Director of Quality GMP with expertise in quality assurance to oversee all GMP/GDP quality aspects of externally supplied drug substances and drug products for novel molecular glue degrader (MGD) programs. The role involves ensuring quality compliance across all phases of manufacturing, testing, and distribution,...
-
Director – Quality GMP Small Molecules
vor 2 Wochen
basel, Schweiz Monte Rosa Therapeutics, Inc VollzeitOverview Monte Rosa Therapeutics. looking for a Director Quality GMP with quality expertise to support all GMP/GDP quality aspects of externally produced supply of drug substance and drug product for novel molecular glue degrader (MGD) programs, making a difference for our patients every day. Responsible for oversight of phase-appropriate Monte Rosa Quality...
-
Director – Quality GMP Small Molecules
Vor 7 Tagen
Basel, Basel-Stadt, Schweiz Monte Rosa Therapeutics Vollzeit CHF 120'000 - CHF 180'000 pro JahrOverviewMonte Rosa Therapeutics. looking for a Director Quality GMP with quality expertise to support all GMP/GDP quality aspects of externally produced supply of drug substance and drug product for novel molecular glue degrader (MGD) programs, making a difference for our patients every day. Responsible for oversight of phase-appropriate Monte Rosa Quality...
-
Director Global Msat, Small Molecules
vor 7 Stunden
Basel, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
Associate Director, External Supply Quality Europe
vor 4 Wochen
Basel, Schweiz BeOne Medicines VollzeitOverviewBeOne Medicines is seeking an Associate Director, External Supply Quality Europe. The role has global responsibility for commercial product quality at Contract Manufacturing Organizations (CMOs) and lifecycle management projects, ensuring products are manufactured, packed, labeled, stored and transported in compliance with regulatory expectations and...
-
Associate Director Regulatory Affairs Small
vor 2 Wochen
Basel, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
Basel, Schweiz BeiGene VollzeitBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Associate Director, External...
-
Associate Director, External Supply Quality Europe
vor 2 Wochen
Basel, Schweiz BeiGene VollzeitGeneral Description: - The Associate Director, External Supply Quality organization is responsible for ensuring that externally manufactured commercial products are manufactured, packed, labelled, stored and transported in a controlled way at Contract Manufacturing Organizations in accordance with the regulatory expectations and applicable GMP/GDP quality...
-
Basel, Schweiz BeiGene VollzeitOverviewBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description :The Associate Director,...
-
Associate Director, External Supply Quality Europe
vor 2 Wochen
basel, Schweiz BeiGene VollzeitBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Associate Director, External...
