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Director of Quality Compliance
2 months ago
As a key member of the Abbott Laboratories team, the Director of Quality Compliance will provide strategic and tactical direction for Global Compliance programs. This role will establish, maintain, and improve quality system programs, policies, procedures, compliance, and best practices across division manufacturing sites.
The successful candidate will advise 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. They will maintain a strategic focus on changing global regulations to ensure the business is proactive in addressing any potentially challenging laws or requirements.
Main Responsibilities- Minimize the probability of Quality compliance issues across the entire business enterprise by providing feedback, direction, and strategy to all aspects of the Quality, Operations, Purchasing, R&D, Regulatory, and other functions division-wide.
- 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.
- Provide direction, support, leadership, and management of compliance to Global Regulations, Standards, Directives, and Provisions to maintain a competitive advantage.
- 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 proactively 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.
- Recruit, coach, and develop talent.
- Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
Education
A Bachelor's Degree in Science, Engineering, or Business, or an equivalent combination of education and work experience.
Experience/Background
Minimum 10 years of experience in Quality Assurance/Regulatory in a company with a 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. Experience dealing with Corporate Functions, presenting to Executive Staff, and experience dealing directly with FDA & Global Regulators.
