Site Quality Head

Site Quality Head In Albuquerque, NM

Build your future at Curia, where our work has the power to save lives

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.

We proudly offer:

• 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!

Summary:

The Site Head of Quality at the Albuquerque, NM 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, which consists of Compliance & Quality Systems, Quality Operations (IQA, MQA and Sterility Assurance), Validation, and Quality Control by providing leadership and guidance in quality decision making.

The Quality Control 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.

Essential Duties and Responsibilities

• The 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 and packaging 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 with global cross-contamination control requirements including vaccine manufacturing.
• Provide oversight and direction to the microbiological and chemistry laboratories.
• 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.
• Provide leadership and direction to the quality organization throughout the company.
• Evaluate and recommend solutions and implementation strategies for product/process issues through the use of analytical, technical, and leadership skills. Contribute to core values of quality, timeliness, communication, and profitability.
• Direct and manage the manufacturing quality assurance function: includes monitoring the quality aspects of manufacturing, facilitating incoming quality assurance activities, and ownership of the environmental monitoring system (EVM).
• Direct and manage the quality control function: includes the microbiology laboratory, the chemistry laboratory, environment monitoring, in-process, and finished product release testing, and stability.
• Direct and manage the quality systems function: includes validation, regulatory affairs, compliance, quality systems (Track Wise, Edu Neering, and Documentum), quality engineering, quality assurance documentation, and change control.
• Direct and manage the quality assurance product specialist (QAPS) function: includes coordination of lot release, product-specific expertise concerning manufacturing processes, coordination of investigative activities, constant customer contact to establish, and maintain a beneficial relationship.
• Provide plant management with data and information appropriate to reduce the potential for regulatory action and assist in site productivity management. Keep plant management advised concerning agency, customer, and internal audit compliance commitments.
• Responsible to implement an effective training system at the time.
• Provide technical expertise and internal technical consulting within the facility.
• Responsible to develop and maintain a quality budget on site.
• Other duties as assigned.

Education and Experience:

• Bachelor's degree in Science, Business Management, Engineering, or related field of study
• Minimum of ten (10) years related work experience with progressively greater responsibilities in quality operations in the pharmaceutical (sterile product manufacture) / Biologics / medical devices industry, including project, technical, and personnel management.
• Minimum of…