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Director, Quality Assurance
Director, Quality AssuranceSan Diego Staffing • San Diego, CA, US
Director, Quality Assurance

Director, Quality Assurance

San Diego Staffing • San Diego, CA, US
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  • [job_card.full_time]
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Director Of Quality

Catalent, Inc. is a leading global contract development and manufacturing organization 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.

Role

The Site Quality Director will :

  • Implement strategies and tactical objectives to move the site towards a high-degree operational excellence and mature quality culture.
  • Work with the BU VP Quality and other CSS Quality Directors to create and implement business unit quality strategy, global quality policies, BU quality process harmonization, etc.
  • As a member of the Site Leadership Team, work 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, etc.
  • 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.
  • Professional development, managing work-life balance, strategic planning, etc.

Candidate

The ideal candidate will have :

  • Bachelor's degree in science, engineering, or pharmaceutical discipline or related scientific field.
  • A minimum of ten years' experience working in a chemical, pharmaceutical, food or relevant industry with at least five years' of experience in quality assurance or regulatory affairs with progressive responsibilities.
  • Experience in managing people, providing leadership, and implementing developmental plans for personnel.
  • 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.
  • 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.
  • Resourceful, possess strong time management skills and be able to work with minimal or no supervision to achieve deadlines and objectives.
  • Pay

    The anticipated starting salary range for this role in San Diego, CA is $180,000 to $205,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to : the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer and this salary range may not reflect positions that work in other states.

    Why You Should Join Catalent

    Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

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    Director Quality Assurance • San Diego, CA, US

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