Monte Rosa Therapeutics
Monte Rosa Therapeutics provided pay range
This range is provided by Monte Rosa Therapeutics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $185,000.00/yr - $235,000.00/yr
Position Overview Monte Rosa Therapeutics is seeking a Director of Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities, including GCP quality oversight of ongoing quality activities supporting active pre‑clinical and clinical programs through participation on in‑house and external cross‑functional teams. This role requires an 75% on‑site presence. You will work closely with industry leaders in Boston and Basel. Join a diverse, collaborative, and dynamic team that values innovation, teamwork, and a people‑centric culture!
Responsibilities
Primary GCP quality contact for identified vendors and investigator sites supporting clinical programs as well as other GCP quality events (e.g., potential serious breach assessments, CAPAs)
Author key GCP quality SOPs and key reviewer for other quality (GxP) procedures.
Develop a risk‑based GCP compliance program.
Support teams in the initiation, review, and closure of quality events and associated CAPA, Change Action, and Effectiveness plans.
Develop and provide GCP and other GxP training (as applicable).
Ensure appropriate qualification of vendors and ensure compliant vendor management and regular assessment/audits. May conduct GCP audits (vendors and sites).
Ensure audit observations are communicated, tracked and remediated.
Provide QA GCP review and feedback on regulatory submissions.
Lead and participate in inspection readiness activities for regulatory inspections – both internally and at clinical sites.
Interface with internal departments and external vendors on a variety of technical/quality subjects.
Qualifications
BS Degree in Chemistry, Pharmacy, Biology or a related life science, or a combination of a BS Degree with relevant Quality and Technical experience.
Minimum of 16 years of experience within the pharmaceutical or biopharmaceutical industry, with development experience and exposure to commercial operations.
Knowledge and experience of clinical and commercial systems supporting GCP compliance with US and global regulations (FDA, EMA, ICH, MHRA, etc.). GLP experience a plus.
Able to provide solution‐minded approach and flexibility to emerging challenges.
Able to appropriately balance priorities plus multi‐task against competing priorities.
Proven experience with the desire, and ability to work in a fast‑paced, matrixed, start‑up environment.
Hands‑on leader, able to provide solution‐minded approach and flexibility to emerging challenges.
Understanding of drug development and program management preferred.
Interested Candidates may forward a CV and Cover Letter in a single PDF via our online portal https://www.monterosatx.com/careers/.
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 https://www.monterosatx.com.
Seniority level Director
Employment type Full‑time
Job function Quality Assurance
Industry Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at Monte Rosa Therapeutics by 2x.
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Base pay range $185,000.00/yr - $235,000.00/yr
Position Overview Monte Rosa Therapeutics is seeking a Director of Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities, including GCP quality oversight of ongoing quality activities supporting active pre‑clinical and clinical programs through participation on in‑house and external cross‑functional teams. This role requires an 75% on‑site presence. You will work closely with industry leaders in Boston and Basel. Join a diverse, collaborative, and dynamic team that values innovation, teamwork, and a people‑centric culture!
Responsibilities
Primary GCP quality contact for identified vendors and investigator sites supporting clinical programs as well as other GCP quality events (e.g., potential serious breach assessments, CAPAs)
Author key GCP quality SOPs and key reviewer for other quality (GxP) procedures.
Develop a risk‑based GCP compliance program.
Support teams in the initiation, review, and closure of quality events and associated CAPA, Change Action, and Effectiveness plans.
Develop and provide GCP and other GxP training (as applicable).
Ensure appropriate qualification of vendors and ensure compliant vendor management and regular assessment/audits. May conduct GCP audits (vendors and sites).
Ensure audit observations are communicated, tracked and remediated.
Provide QA GCP review and feedback on regulatory submissions.
Lead and participate in inspection readiness activities for regulatory inspections – both internally and at clinical sites.
Interface with internal departments and external vendors on a variety of technical/quality subjects.
Qualifications
BS Degree in Chemistry, Pharmacy, Biology or a related life science, or a combination of a BS Degree with relevant Quality and Technical experience.
Minimum of 16 years of experience within the pharmaceutical or biopharmaceutical industry, with development experience and exposure to commercial operations.
Knowledge and experience of clinical and commercial systems supporting GCP compliance with US and global regulations (FDA, EMA, ICH, MHRA, etc.). GLP experience a plus.
Able to provide solution‐minded approach and flexibility to emerging challenges.
Able to appropriately balance priorities plus multi‐task against competing priorities.
Proven experience with the desire, and ability to work in a fast‑paced, matrixed, start‑up environment.
Hands‑on leader, able to provide solution‐minded approach and flexibility to emerging challenges.
Understanding of drug development and program management preferred.
Interested Candidates may forward a CV and Cover Letter in a single PDF via our online portal https://www.monterosatx.com/careers/.
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 https://www.monterosatx.com.
Seniority level Director
Employment type Full‑time
Job function Quality Assurance
Industry Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at Monte Rosa Therapeutics by 2x.
#J-18808-Ljbffr