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Director, Quality Assurance

Director, Quality Assurance

Ratio TherapeuticsSalt Lake City, UT, US
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Director, Quality Assurance

Ratio Therapeutics is committed to improving and extending the lives of cancer patients without sacrificing their quality of life. We are a team of passionate scientists, engineers, and business professionals dedicated to advancing the field of targeted radioligand therapy. To accomplish this, we utilize our proprietary TRILLIUM and MACROPA platforms : TRILLIUM allows fine-tuning of radioligand pharmacokinetics thereby enhancing the therapeutic index, while MACROPA simplifies the manufacturing process for the alpha-emitting isotope, actinium-225. These enabling platform technologies have resulted in an emergent pipeline of novel therapeutic candidates. We are looking for talented, dedicated, and creative individuals eager to help us advance these technologies from discovery research through clinical development. Join us in our quest to become the leading innovator in radioligand therapy and improve the lives of cancer patients and their families.

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 critical member of the site leadership team, collaborating with peers from 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 overall 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 all 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, Standard Operating Procedures (SOPs), training programs, change control, and supplier quality management.
  • Direct the quality event management process, including the investigation of deviations, out-of-specification (OOS) results, and customer complaints, ensuring thorough root cause analysis and effective Corrective and Preventive Actions (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 the development and manufacturing processes from the start.
  • Lead process validation and cleaning validation efforts, ensuring all equipment and processes consistently meet pre-defined quality standards.
  • Team Leadership & Development

    • Recruit, train, and mentor a high-performing QA team, providing clear direction and fostering a collaborative environment.

  • Conduct performance reviews and create professional development plans to build a skilled and motivated team.
  • Report directly to the Head of Quality, providing regular updates on quality metrics, key initiatives, and challenges.

    • Required Qualifications

  • A minimum of 7-10 years of experience in a regulated pharmaceutical manufacturing environment, with at least 3-5 years in a leadership role within Quality Assurance.
  • Proven, in-depth knowledge of U.S. and international cGMP regulations, with a strong focus on 21 CFR Part 211 (cGMP for Finished Pharmaceuticals) and 21 CFR Part 11 (Electronic Records).
  • QMS & Process Knowledge : Demonstrated experience in developing, implementing, and managing a comprehensive Quality Management System (QMS). Must be well-versed in key quality processes such as SOP writing, quality event management (deviations, CAPAs), change control, and root cause analysis.
  • Exceptional leadership and team-building skills, with a track record of successfully managing, mentoring, and developing a quality team. The ability to work collaboratively and influence stakeholders across multiple functions (e.g., QC, Production, Engineering).
  • Bachelor's degree in relevant scientific or technical discipline (e.g., Chemistry, Biology, Pharmacy, or Engineering).

    • Preferred Qualifications

  • Direct experience working in radiopharmaceutical manufacturing or a sterile / aseptic manufacturing environment.
  • An advanced degree (Master's, PhD) in a relevant scientific or business field.
  • Practical experience applying Quality by Design principles to enhance product and process development.
  • Prior experience leading and managing regulatory inspections from bodies such as the FDA.
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