Senior Director Manufacturing Quality US & APAC

Abbott • Alameda, CA

1d • Onsite

About The Position

The Sr. Director, Manufacturing QA directs and coordinates the Quality Assurance activities and functions for the Division Manufacturing Plants and Third-Party Manufacturing (TPM) facilities globally. Responsibilities include designing and implementing a vast array of quality assurance systems, processes, and programs in alignment with the division Quality System to consistently produce high quality product and drive customer satisfaction, plant compliance and advising the Division Vice Presidents of Quality Assurance / Regulatory Affairs on critical events such as product quality, safety, and regulatory issues. The position also has direct interface and activity/strategy coordination with leadership teams in Global Operations, Engineering, R&D, and Commercial Operations, Regulatory Affairs and Legal. This extends to external business partners and regulators.

Requirements

• Bachelor’s degree in a scientific or technical field
• Minimum 15 years Quality or Compliance discipline in the Medical Device Industry or other FDA regulated industry holding positions of leadership responsibility
• Must be articulate and able to communicate effectively with Corporate officers, DVPs, directors, managers and employees across the corporation
• Must influence decisions made by Operations, R&D, Commercial, and other disciplines to maintain customer satisfaction and division expectations
• Substantial Knowledge of FDA/International guidelines for device

Nice To Haves

• Master’s degree in business or a technical field

Responsibilities

• Direct the Plant and Abbott Diabetes Care (ADC) TPM Quality Assurance Manufacturing / Operations Organizations.
• Assure line of communication with DVP QA and Senior Leaders on critical quality issues that may result in potential business interruption.
• Develop quality strategy to achieve business objectives at the plant level while ensuring operations are in compliance with global regulatory requirements, making key decisions on product quality and regulatory conformance issues.
• Support the resolution of product quality issue resolutions with on market products.
• In conjunction the Product Quality team, monitor consumer complaint trends, identify, communicate, and address adverse trends that may impact future business.
• Direct and implement programs at the manufacturing plants to comply with all regulatory requirements, including ISO standards to ensure product and services meet customer expectations.
• Provide oversight to disposition of high-risk product non-conformance situations, assure adequate investigation and corrective actions are in place to prevent future occurrences.
• Control budget and quality costs of both ADC QA operations and Division staff.
• Authorize cost efficiency projects that contributes to Division margin improvement initiatives.
• Assure successful launch of new and revised products by incorporating the appropriate quality assurance programs/systems into plant operations to meet goals for the division.
• Assure business continuity in leadership positions and critical roles through talent management planning and development.
• Interface with outside regulators (FDA, Ministries of Health, Notified Bodies, etc.) and other government regulatory bodies, as required.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement
• The Freedom 2 Save student debt program
• FreeU education benefit

What This Job Offers

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