Associate Director of Quality Operations

Associate Director of Quality Operations

Only candidate with minimum of 10 years' experience

This is onsite position in Indianapolis, Indiana, USA

This is a full-time position

Director of Quality Operations at our state-of-the-art Radiopharmaceutical Manufacturing Facility in Indianapolis, IN (USA).  This role will be responsible for overseeing all Quality aspects related to GMP production of Isotopes and the pipeline of radiopharmaceutical drug products for global clinical trial and commercial use.

This role will partner with external and internal stakeholders driving Quality Systems at the Indianapolis site.  The Director of Quality Operations will drive a culture of Quality and ensure GMP compliance and the successful and timely execution of day-to-day production operations supporting global distribution of isotope and drug products.

Additional responsibilities include establishing and managing Quality Operational KPI’s, supporting and driving operational improvements within the Quality organization.  The Director of Quality Operations will support the sites transition for clinical to commercial operations and be a key Quality leader supporting operational readiness for QP, PAI and other Regulatory Authority quality audits. This role will drive a site culture of Quality with a patient first mindset.

This role is stationed in Indianapolis, IN and reports to the Executive Director of Quality s for the company based in San Diego, CA.

 Job Responsibilities

 Essential duties and responsibilities include the following.  Other duties may be assigned.

• Responsible for Quality Operations oversight and day-to-day Quality management related to isotope and Radiopharmaceutical drug product manufacturing at the Indianapolis facility.
• Ensure adherence to applicable GMP regulations and company policies and procedures.
• Collaborate with other business leaders across the organization to support the development, continuous improvement and lifecycle management of GMP policies and procedures.
• Provide leadership and build an exceptional Quality Operations team.
• Champion and foster a positive and quality compliant culture with a patient safety mindset.
• Lead the implementation of site readiness for FDA Pre-Approval Inspection Pre-license inspection.
• Support compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMA, PMDA, etc.).
• Establish and manage Quality Operational KPI’s and related metrics.
• Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Clinical Operations, Logistics, and MS&T, to ensure the ongoing qualified and operational readiness for commercial manufacturing at the facility.
• Support the implementation of corporate initiatives and ensure success toward annual corporate goals and objectives.

Education and Experience

•  BS/MS in relevant Science or Engineering discipline and 10 years of experience in building, managing and leading Quality Operations teams
• Proven expertise in GMP operations and compliance for global clinical trial and commercial injectable or radiopharmaceutical operations required.
• Strong background in US/EU regulations with regulatory agency inspection experience required.
• Experience implementing and improving GMP Quality systems related to commercial manufacturing operations is required
• Demonstrated Quality leadership through a partnership approach with manufacturing and other Quality teams to enable high quality and compliant product distribution to patients is required
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
• Demonstrated excellence in written and verbal communication
• Previous experience in a commercial GMP parenteral facility, previous Radiopharma experience a plus
•  Skills and Qualifications
•  Beyond having the requisite experience and qualifications, a successful candidate will have a proven history of team and personnel leadership with high levels of self-motivation, adaptability, critical thinking, analysis, and creative problem-solving. This is a fast-paced position within a fast-paced organization, so the ability to come in and hit the ground running is critical for success in the role.