Associate Director Quality Systems

4 weeks ago

Boston, United States Monte Rosa Therapeutics, Inc Full time

Overview:

Monte Rosa Therapeutics is seeking a passionate Associate Director/Director of Quality Systems is responsible for maintaining and maturing Monte Rosa Txs GxP Quality System, which includes, but is not limited to documentation, training, supplier quality, internal audits, product complaints, risk management, change controls, deviations and CAPAs. The Quality Systems leader will also provide technical quality oversight for the qualification and validation of facilities, systems and equipment, as well as process validation. Responsible for oversight of phase-appropriate Monte Rosa Quality System (QS) activities, including Document Management and Training, Quality Event Management (Deviations, Change Control, CAPAs, Investigations), Metrics, Risk Management, Product Complaints/Recalls, Audit and Supplier Management. Supporting quality systems in both Boston and Basel locations.

Responsibilities:
  • Manage and support the document creation and lifecycle process, including periodic reviews.
  • Ensure GxP training and employee qualification is properly managed and compliant. Provide GxP and GxP system training where applicable.
  • Manage and maintain the audit schedule and auditor qualifications. Ensure audit observations are communicated, tracked and remediated.
  • Provide a risk-based oversight of vendor selection, qualification and management.
  • Support, manage the quality event/issue identification, assessment, resolution, and effectiveness confirmation as well as educate/support record owners.
  • Support and participate in inspection readiness activities for regulatory inspections both internally and at sites (GCP and GMP).
  • Facilitate the Quality Management Reviews including quality metrics and key quality topics for leadership
  • Support Computer System Validation quality efforts as applicable for GxP Systems. This also includes being an administrator for electronic Quality Systems (i.e., DMS, LMS, QMS) as applicable.
  • 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 12 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 compliance with US and global regulations (FDA, EMA, ICH, 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.
  • Strong collaboration and team-working, communication, and organizational skills required.
  • Strong problem-solving, critical thinking, and analytical skills necessary
  • Ability to travel up to 10%.

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