Site Quality Head

Curia • Camarillo, CA

21h • Onsite

About The Position

The Site Head of Quality at the Camarillo, CA facility is responsible for establishing and maintaining the site quality system to meet the regulatory expectations and cGMP requirements for various global regions. This position’s responsibilities include leading the site Quality organization (QA & QC) by providing leadership and guidance in quality decision making. The QC laboratories include both the chemistry and microbiology teams. The Site Head of Quality is also responsible for directing and providing leadership for the implementation of Curia global standards and procedures to ensure quality decisions are made conforming to highest standards and in the successful operation of the Quality Organization. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

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/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
• Must pass a 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

Responsibilities

• Site Head of Quality provides technical, quality oversight and support to the VP of Quality Operations in making quality decisions
• Ensures adequate manufacturing quality oversight across manufacturing operations. Responsible for all aspects of GMP compliance. This includes quality oversight from the point of material dispensing through final product dispatch for all products
• Provide guidance and processes that would comply to 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 in each operation throughout the facility
• Drive accountability for all decisions made affecting product and process quality and determine need for escalation
• Provide leadership, subject matter expertise and direction to the Quality Organization throughout the company
• Evaluate and recommend solutions and implementation strategies for product/process issues through use of analytical, technical and leadership skills
• Contribute to core values of Quality, Timeliness, Communication and Profitability
• Develop, direct and manage the Manufacturing Quality Assurance function
• Develop, direct and manage the Quality Control function
• Includes the Microbiology laboratory
• Includes the Chemistry laboratory
• Environmental monitoring
• Develop, direct and manage the Quality Systems & Compliance function
• Develop, direct and manage the Quality Assurance function
• Manage resources to ensure stability testing is completed on time to meet customer requirements
• Hire and retain top talent and support career development of team
• Provide plant management with data and information appropriate to reduce potential for regulatory action and assist in site productivity management. Keep plant management advised concerning agency, customer, and internal audit compliance commitments
• Responsible to develop and maintain Quality budget on site

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior