Site Quality Head

About the role

The Site Head of Quality at the Camarillo, CA facility is responsible for establishing and maintaining the site quality system to meet regulatory expectations and cGMP requirements for various global regions. This position leads the site Quality organization (QA & QC), providing leadership and guidance in quality decision-making. The QC laboratories include both chemistry and microbiology teams. The role also directs the implementation of Curia global standards and procedures to ensure quality decisions conform to the highest standards and support the successful operation of the Quality Organization.

Responsibilities

• Provide technical, quality oversight and support to the VP of Quality Operations in making quality decisions.
• Ensure adequate manufacturing quality oversight across manufacturing operations, including all aspects of GMP compliance from material dispensing through final product dispatch.
• Provide guidance and processes to comply with global cross-contamination control requirements.
• Support plant management groups on new products, changes to products, processes, and services to achieve a consistent approach to Quality Assurance and Regulatory Affairs.
• Direct quality and compliance process improvements and goals for the site using current regulations and demonstrated best practices.
• Support effective and efficient continuous quality and cost improvement efforts.
• Ensure requirements of Curia global Quality Systems are implemented and maintained throughout the facility.
• Drive accountability for all decisions made affecting product and process quality and determine the need for escalation.
• Provide leadership, subject matter expertise, and direction to the Quality Organization.
• Evaluate and recommend solutions and implementation strategies for product/process issues using analytical, technical, and leadership skills.
• Contribute to core values of Quality, Timeliness, Communication, and Profitability.
• Develop, direct, and manage the Manufacturing Quality Assurance, Quality Control (including Microbiology and Chemistry laboratories), Quality Systems & Compliance, and Quality Assurance functions.
• Oversee environmental monitoring and ensure stability testing is completed on time to meet customer requirements.
• Hire and retain top talent and support career development of the team.
• Provide plant management with data and information to reduce potential for regulatory action and assist in site productivity management.
• Keep plant management advised concerning agency, customer, and internal audit compliance commitments.
• Develop and maintain the Quality budget on site.

Requirements

• BS or BA in a scientific field; microbiology preferred.
• Minimum of 15 years of progressively greater responsibilities in Quality Operations in the pharmaceutical (sterile product manufacture), Biologics, or medical devices industry, including project, technical, and personnel management.
• Must possess effective communication skills to collaborate with others and proactively resolve obstacles.
• Must pass a background check and drug screen.
• May be required to pass Occupational Health Screening.
• May be required to obtain and maintain gowning certification.
• May be required to obtain and maintain media qualification.

Benefits

• Generous benefit options (eligible first day of employment).
• Paid training, vacation, and holidays (vacation accrual begins on first day of employment).
• Career advancement opportunities.
• Education reimbursement.
• 401K program with matching contributions.
• Learning platform and more.

Pay

Pay Range: $186,000–$230,000/year. Education, experience, location, and tenure may be considered along with internal equity when job offers are extended.