Senior Director, Manufacturing Quality Abbott Diabetes Care (ADC)

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Senior Director, Manufacturing Quality Abbott Diabetes Care (ADC)

Apply locations Ireland - Kilkenny Ireland - Donegal Town United Kingdom - Witney Ireland - Dublin Ireland > Sligo : Castle Street time type Full time posted on Posted 4 Days Ago job requisition id 31058948

JOB DESCRIPTION:

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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

The Opportunity The Senior Director, Manufacturing Quality 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. What You’ll Work On

• Direct the Plant and 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.

Qualifications

• Bachelors Degree in a scientific or technical field required.
• Masters Degree in business or a technical field preferred.
• Minimum 15 years in 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.
• Possess substantial knowledge of FDA/International guidelines for device.

Apply Now * Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

ADC Diabetes Care

LOCATION:

Ireland > Kilkenny : Kilkenny Business and Technology Park

ADDITIONAL LOCATIONS:

Ireland > Donegal Town : Plant House, Ireland > Dublin : Block G, Cherrywood, Cherrywood Business Park, Ireland > Sligo : Castle Street, United Kingdom > Witney : Range Road, United States > Alameda : 2901 Harbor Bay Parkway

WORK SHIFT:

Standard

TRAVEL:

Yes, 20 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Keyboard use (greater or equal to 50% of the workday)

About Us

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott  welcomes and encourages diversity in our workforce. #J-18808-Ljbffr