Director, Quality Systems and Compliance

Job Summary:

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.

Key Responsibilities:

• 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.
• 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.
• 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 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.