Director, Quality Assurance

Catalent Pharma Solutions-posted 2 months ago
$180,000 - $205,000/Yr
Full-time • Senior
San Diego, CA
5,001-10,000 employees
Chemical Manufacturing
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Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. The following summary represents an ideal situation for a site with a high degree of operational excellence and a mature Quality Culture. The Site Quality Director will implement strategies and tactical objectives to move the site towards this general model over time.

  • Global leadership: working with the BU VP Quality and the other CSS Quality Directors to create and implement Business Unit quality strategy, global quality policies, BU quality process harmonization.
  • Site leadership: As a member of the Site Leadership Team working with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility.
  • Lead the development of site Quality Objectives, site Quality Plans, Quality Management Reviews.
  • Overall responsibility for the site Quality Assurance and regulatory compliance functions.
  • Oversee and execute all Performance Management Program (PMP) actions for the site Quality Assurance department.
  • Internal Investigations on cGMP issues, trends, and customer complaints.
  • Review and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity.
  • Oversite of data Integrity programs, process integration and procedural harmonization with other CSS sites, raw materials and finished goods release processes, and Environmental Monitoring Program.
  • Customer and Regulatory Audits, including coordination and submission of Catalent responses.
  • Communication and escalation of quality issues to Site Leadership Team and QA senior management.
  • Site Training program.
  • Supplier and internal audits (including coordination with IACP program).
  • Site Label Control, including review, release and approval process.
  • In-process QA activities, including line clearance and room release, in-process and receiving inspections, and raw material/product sampling.
  • Implement Global quality policies and standards and CSS network procedures at the site.
  • Continuous process improvements, particularly as a function of site deviation rate and recurrent deviation rate.
  • Other duties as assigned.
  • Bachelor's Degree in Science, Engineering, or Pharmaceutical discipline or related scientific field required.
  • A minimum of ten (10) years' experience working in a chemical, pharmaceutical, food or relevant industry with at least five (5) years' of experience in Quality Assurance or Regulatory Affairs with progressive responsibilities.
  • Experience in managing people, providing leadership, and implementing developmental plans for personnel required.
  • Direct experience and working knowledge of Validation principles, including validation of processes, equipment, systems, analytical methods, cleaning, and transportation.
  • Working knowledge of US and International cGMP regulations and experience working directly with the local and international regulatory agencies.
  • Must have a demonstrable record of implementing and maintaining quality systems; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics.
  • Must be resourceful, possess strong time management skills and be able to work with minimal or no supervision to achieve deadlines and objectives.
  • Demonstrable leadership experience at Catalent may be considered in place of external experience.
  • Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance).
  • Group Retirement Savings- Registered Pension Plan (RPP) with employer contributions.
  • Paid Time Off Programs including Vacation, banked time, and personal time.
  • Employee Reward and Recognition Programs.
  • Opportunities for professional and personal development.
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