Director Quality Assurance

Job Title

About the role

The Director Quality Assurance is responsible for managing the Quality Assurance Department and the Quality System to achieve compliance with Corporate and Division requirements for the Casa Grande, AZ site. They are responsible for leading the compliance inspections and fostering a culture of Quality and Food Safety.

Responsibilities

• Establishes and implements Quality Assurance procedures for inspecting and controlling raw or packing materials and assaying in-process and finished product to insure that all products generated conform to predetermined Corporate/Division standards and specifications.
• Provides direction to assure that the facilities have the system knowledge, capabilities and practices to comply with all internal Quality Assurance and Food Safety policies and procedures in addition to all pertinent FDA, USDA, State and customer requirements.
• Ensures Food Quality and Food Safety Plans are current, relevant and are being followed and implemented.
• Ensures all HACCPs are appropriate and records are complete and accurate.
• Maintains CAPA Programs to ensure Root Cause analysis is performed and timely closure.
• Leads the quality activities at the site ensuring the appropriate staffing is available at all times and skills and competencies are consistent with present and future needs.
• Conducts value analyses to optimize use of these resources.
• Reviews performance of the department and personnel against approved objectives, budgets and plans, and takes necessary remedial actions.
• Monitors, audits and approves facilities and manufacturing operations for conformance with established procedures and requirements of the Corporate and Governmental GMPs, such as Low Acid Food and Infant Formula Regulations.
• Ensures maintenance of required records and documents, including formula test results, inspections, file samples, vendor performance, product complaints, product disposition, state and federal regulations.
• Interfaces directly with the FDA, USDA, and various global, state and local agencies.
• Interfaces with external suppliers and vendors as well as external government and industry forums.
• Makes sure the plant Quality System is monitored and reported on to Division QA.
• Drives Continuous Improvement using Quality Analytics to monitor leading and lagging indicators of Quality and Food Safety.
• Supports plant and Division activities in introducing new products through the plant and clinical products for testing and data evaluation.
• Supports major plant project expansions and new products to assure proper technical input and regulatory requirements are met.
• Manages complex laboratories which include chemical, biological, sterility and environmental testing.
• Interacts with appropriate Division QA functions and key stakeholders to understand and troubleshoot product complaints and improve customer service/product performance.
• Provides a Quality Engineering function to identify and implement statistically driven quality programs (SPC) as well as to provide assistance in continuous improvement in all manufacturing areas.
• Coordinates or aids in problem evaluation and problem solving.
• Responsible for QA oversight and approval of validation protocols, programs and reports which includes : process, cleaning, equipment, and computerized systems.
• Ensures the validation program is consistent with AN validation policy.
• Provides a Vendor Quality function to assure that suppliers have appropriate quality systems and process controls to guarantee the delivery of usable inventories of the needed quality.
• Conducts performance reviews; develops growth plans; interprets, implements and supports employee-related policies, procedures and programs.
• Sets up and assigns projects/tasks to direct staff.
• Affirms compliance to all procedures and policies concerning all areas of quality, regulatory, safety and human resources for all departments.

Requirements

• Bachelor’s degree + 16 years’ experience
• 10+ years of experience in Quality Assurance within food or FDA Regulated manufacturing
• 5+ years of management experience
• Cross functional experience in operations, engineering or alternate technical function in addition to quality leadership
• Management of external regulatory inspections, audits, and experience liaising with competent authorities
• Excellent communication skills and the ability to motivate and develop employees
• Ability to motivate all departments to produce quality products

Qualifications

• Bachelor’s degree preferred

Skills

• Strong leadership and motivational skills
• Excellent communication and interpersonal skills
• Experience with regulatory compliance and quality assurance
• Knowledge of Good Manufacturing Practices (GMP)
• Ability to manage and lead a team
• Strong analytical and problem-solving skills

Benefits

At Abbott, you can enjoy a comprehensive benefits package including:

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Pay

The base pay for this position is $171,300.00 – $342,700.00. In specific locations, the pay range may vary from the range posted.