Manager, Document Control and Training

About the role

The Manager, Document Control and Training oversees the Document Management and Training Management systems and processes. This includes supporting Quality Metric reporting at QMS Boards and Management Review meetings, internal audits related to document and training management, inspection readiness, and regulatory authority inspections. The role focuses on continuously improving GXP Document and Training processes and leading organizational changes.

Responsibilities

• Serve as a primary GCP Quality contact for assigned vendors and investigator sites supporting clinical programs.
• Support the identification, assessment, documentation, and management of GCP quality events, including deviations, potential serious breaches, CAPAs, change actions, and effectiveness checks.
• Author and maintain assigned GCP SOPs, work instructions, and templates; review other GxP procedures as needed.
• Support risk-based quality management (RBQM) activities, including quality risk assessments and mitigation plans in alignment with established quality strategy.
• Support vendor qualification activities, ongoing vendor oversight, and periodic assessments or audits; may conduct GCP audits of vendors and investigator sites.
• Track, document, and support remediation of audit observations to ensure timely and effective resolution.
• Provide GCP and other GxP training to internal teams and external partners, as applicable.
• Perform QA GCP reviews of selected regulatory documents and submissions to ensure accuracy and compliance, as applicable.
• Participate in and support inspection readiness activities as well as regulatory inspections, including preparation of materials and responses.
• Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, and other internal teams on quality and compliance topics.

Qualifications

• Bachelor’s degree in science or related field with 8 - 10+ years of GxP Quality experience in the life sciences industry or equivalent experience.
• Demonstrated experience in managing pharmaceutical quality systems such as Document Management and Training, Quality Metrics reporting.
• Experienced in electronic Quality Management and Training Management Systems.
• Excellent communication and time management skills.
• Strong presentation, verbal, and written communication skills.
• Ability to project manage and lead cross-functional teams in a fast-paced environment.
• Demonstrated experience in leading, managing, and improving pharmaceutical quality systems.
• Strong leadership, technical, management, problem-solving, and project management skills.
• Ability to quickly understand issues, needs, and articulate potential solutions in a fast-paced environment.

About the company

Monte Rosa Therapeutics takes a rational approach in targeting disease-causing proteins for degradation to deliver pioneering therapies for cancer and other diseases. The company recognizes the urgent need for a conceptual change in treatment development and is missioned to develop innovative protein degraders as a solution. Combining deep knowledge, insight, and leading-edge science, Monte Rosa’s integrated engine is built for this purpose.