Abbott
Director, Quality Systems and Compliance
Abbott, Alameda, California, United States, 94501
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
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 Abbott Diabetes Care (ADC) is looking for a Director of Quality Systems and Compliance. This person will provide strategic and tactical direction for Global Compliance programs. The Director will establish, maintain and improve quality system programs, policies, procedures, compliance and best practices across division manufacturing sites, Mergers and Acquisitions, or other programs established within the Program Management office. The Director will advise the DVP of QA and other senior staff on critical matters such as compliance risks within the division's manufacturing plants, TPMs, suppliers nonconformance evaluations and other potential emerging issues, and maintain a strategic focus on changing global regulations so the business is proactive to address any potentially challenging laws or requirements. This person will interact with regulators, government agencies, and participate with global organizations associated with the industry to allow for external personnel become more aware of the business and the expertise within the organization. The Director is responsible for ensuring quality systems and/or programs for distribution centers, pilot plants, research facilities, and contracted sites meet Abbott quality standards. What You'll Work On Minimize the probability of Quality compliance issues by providing feedback to all aspects of the quality, operations, Purchasing, R&D, regulatory and other functions division wide, through effective interface with division personnel. Build positive relationships globally with federal, state, local regulatory agencies, and law enforcement officials to further strengthen Abbott's reputation as a pro-active cooperative company dedicated to delivering superior quality products. Develop strategies to minimize, reduce, or otherwise eliminate potential adverse publicity, business interruption, corporate liability, loss of consumer confidence, and / or lost sales. Provide direction, support, leadership and management of compliance to Global Regulations, Standards, Directives, and Provisions to maintain a competitive advantage. Work with corporate, other divisions and cross functional teams to establish governance to assure policy, procedures and processes are compliant for the intended markets and respective regulatory requirements. Direct the division global audit program, including developing a standard process and implementing audits of manufacturing sites, third party manufacturers, quality systems, clinical sites, laboratories, suppliers and warehouses around the world. Direct the coordination of corrective action responses to Corporate audits and regulatory inspections. Fulfill administrative responsibilities of budgeting, staffing, performance reviews, organizational inventory, and personnel development. Develop quality strategies and oversee tactical execution to assure the long-range success of the organization. Monitor trends and react pro-actively with programming to maintain quality compliance and minimize regulatory risk. Develop and implement global programs that support the success of the business. Maintain cooperation and build relationships with outside agencies continually focusing on the impact to the business. Evaluate global quality and regulatory compliance and report vulnerability to Executive management. Keep current and strategic with regulatory requirements, proposals and best practices via constant surveillance of governmental publications. Required Qualifications 10+ years Quality management and supervisory experience. Experience in Quality Assurance/Regulatory in a company with medically focused manufacturing environment. Working knowledge of regulations and standards affecting Medical Device manufacturing (e.g. QSR, ISO, EN Quality System Requirements). Demonstrated experience with development, implementation and management of company-wide quality system procedures/practices. Experience in management of direct resources or cross functional teams. Proven ability to work successfully cross-functionally and collaboratively to problem solve, initiate and manage projects, influence internal and external groups and provide leadership from a quality perspective. Highly developed written, oral and interpersonal skills, critical thinking skills, industry practices, current thinking of regulators & Notified Bodies. Ability to work with Corporate Functions, presenting to Executive Staff & experience dealing directly with FDA & Global Regulators. 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:
www.abbottbenefits.com 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
www.abbott.com , on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews and @AbbottGlobal The base pay for this position is
$186,300.00 – $372,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:
Operations Quality DIVISION:
ADC Diabetes Care LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard TRAVEL:
Not specified MEDICAL SURVEILLANCE:
Not Applicable SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day). Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English:
http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol:
http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
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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 Abbott Diabetes Care (ADC) is looking for a Director of Quality Systems and Compliance. This person will provide strategic and tactical direction for Global Compliance programs. The Director will establish, maintain and improve quality system programs, policies, procedures, compliance and best practices across division manufacturing sites, Mergers and Acquisitions, or other programs established within the Program Management office. The Director will advise the DVP of QA and other senior staff on critical matters such as compliance risks within the division's manufacturing plants, TPMs, suppliers nonconformance evaluations and other potential emerging issues, and maintain a strategic focus on changing global regulations so the business is proactive to address any potentially challenging laws or requirements. This person will interact with regulators, government agencies, and participate with global organizations associated with the industry to allow for external personnel become more aware of the business and the expertise within the organization. The Director is responsible for ensuring quality systems and/or programs for distribution centers, pilot plants, research facilities, and contracted sites meet Abbott quality standards. What You'll Work On Minimize the probability of Quality compliance issues by providing feedback to all aspects of the quality, operations, Purchasing, R&D, regulatory and other functions division wide, through effective interface with division personnel. Build positive relationships globally with federal, state, local regulatory agencies, and law enforcement officials to further strengthen Abbott's reputation as a pro-active cooperative company dedicated to delivering superior quality products. Develop strategies to minimize, reduce, or otherwise eliminate potential adverse publicity, business interruption, corporate liability, loss of consumer confidence, and / or lost sales. Provide direction, support, leadership and management of compliance to Global Regulations, Standards, Directives, and Provisions to maintain a competitive advantage. Work with corporate, other divisions and cross functional teams to establish governance to assure policy, procedures and processes are compliant for the intended markets and respective regulatory requirements. Direct the division global audit program, including developing a standard process and implementing audits of manufacturing sites, third party manufacturers, quality systems, clinical sites, laboratories, suppliers and warehouses around the world. Direct the coordination of corrective action responses to Corporate audits and regulatory inspections. Fulfill administrative responsibilities of budgeting, staffing, performance reviews, organizational inventory, and personnel development. Develop quality strategies and oversee tactical execution to assure the long-range success of the organization. Monitor trends and react pro-actively with programming to maintain quality compliance and minimize regulatory risk. Develop and implement global programs that support the success of the business. Maintain cooperation and build relationships with outside agencies continually focusing on the impact to the business. Evaluate global quality and regulatory compliance and report vulnerability to Executive management. Keep current and strategic with regulatory requirements, proposals and best practices via constant surveillance of governmental publications. Required Qualifications 10+ years Quality management and supervisory experience. Experience in Quality Assurance/Regulatory in a company with medically focused manufacturing environment. Working knowledge of regulations and standards affecting Medical Device manufacturing (e.g. QSR, ISO, EN Quality System Requirements). Demonstrated experience with development, implementation and management of company-wide quality system procedures/practices. Experience in management of direct resources or cross functional teams. Proven ability to work successfully cross-functionally and collaboratively to problem solve, initiate and manage projects, influence internal and external groups and provide leadership from a quality perspective. Highly developed written, oral and interpersonal skills, critical thinking skills, industry practices, current thinking of regulators & Notified Bodies. Ability to work with Corporate Functions, presenting to Executive Staff & experience dealing directly with FDA & Global Regulators. 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:
www.abbottbenefits.com 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
www.abbott.com , on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews and @AbbottGlobal The base pay for this position is
$186,300.00 – $372,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:
Operations Quality DIVISION:
ADC Diabetes Care LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard TRAVEL:
Not specified MEDICAL SURVEILLANCE:
Not Applicable SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day). Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English:
http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol:
http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
#J-18808-Ljbffr