Director of Quality Systems

5 days ago

Waltham, Massachusetts, United States Upstream Bio Full time
About the Role

We are seeking a highly skilled and experienced professional to join our team as a Director of Quality Systems at Upstream Bio. As a key member of our organization, you will be responsible for developing, managing, and continuously improving our Quality Systems to ensure compliance with regulatory, functional area, and customer requirements.

Key Responsibilities
  • Quality System Development and Management: Develop, implement, and maintain a Quality Management System (QMS) that meets regulatory requirements and industry standards.
  • Document Control and Compliance: Administer documents for clinical and commercial operations, ensuring they are compliant and fit for purpose.
  • Continuous Improvement: Facilitate initiatives aimed at increasing efficiencies and improving quality processes.
  • Regulatory Compliance: Support the inspection process for regulatory and partner audits, and respond to audit findings.
  • Vendor Qualification: Manage the vendor qualification process to ensure compliance with regulatory requirements.
  • Quality Support: Provide effective and timely quality support to meet corporate timelines, milestones, and regulatory requirements.
  • Process Improvement: Partner with functional teams to identify, administer, and implement optimized system designs for document management, change control, specifications, deviations, and CAPAs.
  • Internal Audit: Manage the internal audit program and process improvements for Quality Systems.
  • Quality Initiatives: Actively influence and participate in quality initiatives from a strategic compliance perspective.
  • Quality Agreements: Draft and review quality agreements with partners and vendors.
  • Project Support: Participate on project teams as assigned.
  • Budgeting: Provide input to the budget in the functional area.
Requirements
  • Education: Bachelor's degree in a scientific discipline, operations research, operations management, business administration, or a related field.
  • Experience: 8-10+ years' experience in the pharmaceutical, biotechnology, or related industry.
  • Knowledge and Skills: Extensive knowledge and understanding of global requirements for GXP and quality systems for clinical manufacturing and supply, and ability to apply said knowledge to make sound quality decisions.
  • Communication and Interpersonal Skills: Excellent verbal and written communication skills, good interpersonal skills, and ability to work collaboratively across functions.
  • Critical Thinking: Excellent critical thinking skills to interpret external regulatory/compliance documents and internal metrics to propose appropriate mitigation.
  • Software Knowledge: Working knowledge of software solutions for QMS.

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