Director – Quality GMP Small Molecules
vor 3 Wochen
Overview 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, supporting pre-clinical and clinical programs through collaboration with internal and external teams. The ideal candidate should thrive in a collaborative, dynamic environment and be committed to making a difference for patients each day. Responsibilities - Oversee external quality activities related to drug substance and drug product manufacturing, testing, and distribution for clinical materials. - Serve as the primary GMP/GDP Quality contact for vendors supporting clinical programs. - Execute quality activities, including working with Qualified Persons, to ensure materials are released per regulatory standards, cGMPs, and project timelines. - Author and review GMP/GDP SOPs and other GxP procedures. - Review documents such as master batch records, analytical methods, validation protocols, lot release data, and stability reports related to CMC activities and regulatory submissions. - Develop and deliver cGMP and GxP training programs. - Manage quality events workflow, including change controls, deviations, investigations, CAPA, risk management, and complaints. - Ensure vendor qualification, management, and regular assessments/audits, including participation in site visits. - Collaborate with CMC to oversee vendor/supplier compliance and QMS/QTA/QAA activities. - Lead and participate in inspection readiness activities for regulatory audits internally and at vendor sites. - Work as part of a cross-functional team comprising internal and external stakeholders from preclinical to clinical stages. Qualifications - Degree in Chemistry, Pharmacy, Biology, or related life sciences; minimum 15+ years of pharmaceutical or biopharmaceutical industry experience (BS: 20+ years, MS: 20+ years, PhD: 15+ years). - Preferred experience with small molecule development and exposure to commercial operations. - Proficiency in GMP standards and regulatory expectations. - Experience in analytical development and quality control in early/mid-phase small molecule development. - Hands-on knowledge of clinical and commercial systems supporting GMP and GDP compliance with US and global regulations (FDA, EMA, MHRA, SwissMedic, ICH). GLP experience is a plus. - Proven leadership skills with a solution-oriented, phased-approach mindset, adaptable to challenges. - Experience working in fast-paced, start-up environments with a collaborative and organizational mindset. - Strong communication, problem-solving, and analytical skills. - Ability to prioritize and multitask effectively. - Willingness to travel up to 15% as needed. #J-18808-Ljbffr
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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...
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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...
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Director - Quality Gmp Small Molecules
Vor 6 Tagen
Basel, Schweiz Monte Rosa Therapeutics, Inc VollzeitOverview: **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)...
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Director Global Msat, Small Molecules
vor 8 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,...
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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...
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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,...
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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...
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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...
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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,...
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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...
