Job Description

Director, Quality Assurance at Catalent

Overview

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 supports pharmacology development, launch, and full life-cycle supply across pharma, biotech, and consumer health customers. Catalent San Diego focuses on analytical development, pre-formulation testing, formulation development, GMP manufacturing, stability storage and testing, and Clinical Supply Services. The Site Quality Director role aims to implement strategies and tactical objectives to move the site toward a high degree of operational excellence and a mature Quality Culture.

Responsibilities

• 30% Global leadership: work with the BU VP Quality and other CSS Quality Directors to create and implement the Business Unit quality strategy, global quality policies, and BU quality process harmonization.
• 30% Site leadership: as a member of the Site Leadership Team, partner with the General Manager to foster a culture of Safety, Quality performance, Operational Excellence, continuous improvement, regulatory compliance, and fiscal responsibility. lead development of site Quality Objectives, site Quality Plans, and Quality Management Reviews.
• 30% Department leadership: overall responsibility for the site Quality Assurance and regulatory compliance functions, including Performance Management Program actions, professional development counseling, performance appraisals, feedback, and talent development/succession planning.
• 10% Personal leadership: professional development and strategic planning.

Governing Role and Scope

• 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.
• Oversight of Data Integrity programs, process integration, and procedural harmonization with other CSS sites, raw materials and finished goods release processes, and Environmental Monitoring Program.
• Coordinate Customer and Regulatory Audits, including management of Catalent responses.
• Communicate and escalate quality issues to Site Leadership Team and QA senior management.
• Oversee Site Training program and supplier and internal audits (including coordination with IACP program).
• Site Label Control, including review, release and approval process; in-process QA activities, line clearance, room release, in-process and receiving inspections, and raw material/product sampling.
• Implement global quality policies and CSS network procedures at the site; pursue continuous process improvements, particularly in deviation rates.
• Other duties as assigned.

Qualifications

• Bachelors Degree in Science, Engineering, or Pharmaceutical discipline or related field required.
• Minimum of ten (10) years in a chemical, pharmaceutical, food, or relevant industry with at least five (5) years 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 process, equipment, systems, analytical methods, cleaning, and transportation validations.
• Working knowledge of US and International cGMP regulations and experience with local and international regulatory agencies.
• Proven ability to implement and maintain quality systems, with strategic planning and tactical execution to improve operational and quality metrics.
• Strong time management, resourcefulness, and ability to work with minimal supervision to meet deadlines and objectives.
• Demonstrable leadership experience at Catalent or participation in Catalent leadership programs may be considered in place of external experience.

Compensation

The anticipated starting salary range for this role in San Diego, CA is $180,000 to $205,000 annually. Final salary depends on factors including experience, education, and business needs. Catalent is a multi-state employer and this range may not reflect positions in other states.

Why You Should Join Catalent

• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance).
• Group Retirement Savings 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.

EEO and Accommodation

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process, please contact DisabilityAccommodations@catalent.com with job number, title, and location.

Notice to Agencies/Search Firms: Catalent is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted without a valid written agreement will not be considered.

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