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.
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