James Miles

Role
Sr Manager Quality Compliance - Pet Cgmp at Jubilant Radiopharma
Location
Pocatello, ID, US
LinkedIn followers
500 followers

About James Miles

My specialty training has been in designing Quality Systems that will meet strict FDA…

Experience

  1. Sr Manager Quality Compliance - Pet Cgmp

    Jubilant Radiopharma

    Aug 2021 — Present

    The Senior Manager, Quality Compliance is responsible for planning and directing the overall PET cGMP and Radiopharmacy quality compliance program including; PET cGMP Quality Assurance policies, programs and initiatives. The focus of this position will involve directing, coordinating and assuring that the Jubilant Radiopharma PET cGMP program meets and/or exceeds FDA standards and requirements for PET drug manufacturing operations. This position requires managing all aspects of PET Quality System; training, auditing, SOP development and implementation, all FDA interactions and correspondence, CAPA program oversight and manage all PET quality related events. The Senior Manager, Quality Compliance will also develop and report on metrics for all PET Quality related events and support the quality team on quality systems related tasks and quality projects within the radiopharmacy network.

Education

  • University of the Pacific

    Doctor of Pharmacy (Pharm.D.), Pharmacy

    1996 — 1999

  • University of Utah

    Radiopharmacist, SPECT & PET Drug Compounding and Manufacturing

    2005 — 2015

  • University of California, Davis

    Bachelor of Science (BS), Biochemistry

    1992 — 1996

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James Miles — Sr Manager Quality Compliance - Pet Cgmp at Jubilant Radiopharma in Pocatello, ID, US | Unifers