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Director, Quality Assurance
Director, Quality AssuranceRatio Therapeutics • San Francisco, CA, United States
Director, Quality Assurance

Director, Quality Assurance

Ratio Therapeutics • San Francisco, CA, United States
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Overview

Director, Quality Assurance role at Ratio Therapeutics

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About Ratio Therapeutics

Ratio Therapeutics is committed to improving and extending the lives of cancer patients without sacrificing their quality of life. We are a team of scientists, engineers, and business professionals dedicated to advancing targeted radioligand therapy. We utilize our TRILLIUM™ and MACROPA™ platforms to enable radiopharmaceutical development and manufacturing. We are looking for talented individuals to help us advance these technologies from discovery research through clinical development.

About the Position

Ratio is seeking a highly motivated and detail-oriented Director, Quality Assurance to lead the on-site quality function at our new radiopharmaceutical manufacturing facility in Salt Lake City, Utah. The ideal candidate is a strategic quality leader with a commitment to fostering a sustainable culture of quality. This role is critical to the site’s success, driving continuous improvement, ensuring regulatory compliance, and building a high-performing QA team from the ground up.

Key Responsibilities

Strategic Leadership

  • Develop and implement a comprehensive quality strategy that aligns with corporate objectives and regulatory requirements for a new radiopharmaceutical manufacturing facility.
  • Serve as a key member of the site leadership team, collaborating with Production, Quality Control, Microbiology, and Engineering to foster a unified, site-wide approach to quality.
  • Drive continuous improvement by establishing quality goals, monitoring performance metrics, and leading strategic initiatives to enhance product quality and operational efficiency.

Regulatory Compliance

  • Act as the site's primary expert on 21 CFR Part 211 (cGMP) and 21 CFR Part 11 (Electronic Records).
  • Lead regulatory inspection readiness activities, including internal audits, and serve as the main point of contact during regulatory agency inspections.
  • Ensure all manufacturing processes, documentation, and quality systems are in full compliance with U.S. and international regulatory standards.

    • Quality System Management

  • Oversee the design, implementation, and management of a robust Quality Management System (QMS) from the ground up.
  • Manage all aspects of the quality system, including document control, SOPs, training programs, change control, and supplier quality management.
  • Direct the quality event management process, including investigation of deviations, out-of-specification (OOS) results, and customer complaints, with thorough root cause analysis and effective CAPAs.

    • Operational Excellence

  • Champion a culture of quality at all levels of the organization, promoting accountability and a proactive mindset.
  • Utilize Quality by Design (QbD) principles to embed quality into development and manufacturing processes from the start.
  • Lead process validation and cleaning validation efforts to ensure equipment and processes meet predefined quality standards.
  • Recruit, train, and mentor a high-performing QA team, providing clear direction and fostering a collaborative environment.
  • Conduct performance reviews and create development plans to build a skilled and motivated team.
  • Report directly to the Head of Quality, providing regular updates on quality metrics, initiatives, and challenges.

    • Qualifications

    Required Qualifications

  • 7-10 years of experience in a regulated pharmaceutical manufacturing environment, with 3-5 years in a leadership role within Quality Assurance.
  • Proven knowledge of U.S. and international cGMP regulations, with emphasis on 21 CFR Part 211 and 21 CFR Part 11.
  • Experience in developing, implementing, and managing a QMS; skilled in SOP writing, quality event management (deviations, CAPAs), change control, and root cause analysis.
  • Exceptional leadership and team-building skills, with ability to work across multiple functions (e.g., QC, Production, Engineering).
  • Bachelor’s degree in a relevant scientific or technical discipline (Chemistry, Biology, Pharmacy, or Engineering).

    • Preferred Qualifications

  • Experience in radiopharmaceutical manufacturing or sterile / aseptic environments.
  • Advanced degree (Master’s, PhD) in a relevant field.
  • Experience applying Quality by Design to product and process development.
  • Experience leading regulatory inspections from bodies such as the FDA.

    • Seniority level

  • Director

    • Employment type

  • Full-time

    • Job function

  • Quality Assurance

    • Note : This description retains core responsibilities and qualifications while removing unrelated postings and boilerplate. If you would like further refinements (e.g., different section order, or stricter adherence to brand language), I can adjust accordingly.

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    Director Quality Assurance • San Francisco, CA, United States