MAIN PURPOSE OF ROLE

Provides strategic and tactical direction for Global Compliance programs. Establishes, maintains and improves quality system programs, policies, procedures, compliance and best practices across division manufacturing sites. Advises the DVP of QA and other senior & Executive staff on critical matters such as compliance risks within the ADC Division's sites, TPMs, suppliers nonconformance evaluations and other potential emerging issues. Maintain a strategic focus on changing global regulations so the business is proactive to address any potentially challenging laws or requirements. 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. Responsible for ensuring quality systems and/or programs for ADC Division Sites meet Abbott quality standards. Directs the Executive Management Review Program and is responsible to ensure appropriate metrics are identified, compiled, and reviewed.

MAIN RESPONSIBILITIES

•Minimize the probability of Quality compliance issues, across the entire business enterprise, by providing feedback, direction & strategy to all aspects of the Quality, Operations, Purchasing, R&D, Regulatory and other functions division wide, through effective interface with division personnel ensuring that safe & effective products are distributed to customers at all times.

•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.

•Provides direction, support, leadership and management of compliance to Global Regulations, Standards, Directives, and Provisions to maintain a competitive advantage. Works 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. Is the business unit representative from a corporate perspective for Quality Systems & Compliance.

•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.

•Fulfil 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.

•Recruits, coaches and develops talent.

•Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

•Directs the Executive Management Review Program for the Division provides Divisional date to the various Corporate Management Review Program and is responsible to ensure appropriate metrics are identified, compiled, and reviewed by a cross-functional team in order to identify adverse trends and the drivers for those trends.

QUALIFICATIONS

Education

Bachelors Degree (± 16 years) Science, Engineering or Business: An equivalent combination of education and work experience

Experience/Background

Minimum 10 years: Experience in Quality Assurance/Regulatory in 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.

Minimum 4 years 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. Dealing with Corporate Functions, presenting to Executive Staff & experience dealing directly with FDA  & Global Regulators.

The base pay for this position is £102,700.00 – £205,300.00. In specific locations, the pay range may vary from the range posted.