Audit Program Manager

This is a fully remote position, open to applicants in Ireland, +3 more states.

📋 Description

• Strategically plan, schedule, and execute internal audits at Abbott Diagnostics manufacturing and commercial affiliate locations.

• Conduct audits of suppliers and third-party manufacturers to assess adherence to regulatory and quality standards.

• Implement audits in accordance with standards that align with regulatory authority inspections.

• Detect compliance risks and quality system deficiencies.

• Offer guidance and suggestions for corrective and preventive measures.

• Facilitate sustainable improvements in quality systems across various sites.

• Stay updated on emerging regulatory trends and evaluate their implications for the business.

• Assist with inspection readiness efforts across Abbott Diagnostics locations.

• Serve as a subject matter expert during audits and inspections.

• Provide compliant solutions to intricate quality and regulatory challenges.

• Create and uphold internal audit schedules.

• Produce audit metrics and compliance reports for both site and divisional leadership.

• Convey audit findings and recommendations effectively.

• Preserve audit documentation and records in compliance with regulatory standards.

• Lead cross-functional quality and compliance initiatives.

• Advocate for initiatives and drive transformation across various sites and functions.

• Collaborate with global stakeholders to enhance quality systems and compliance performance.

⛳️ Requirements

• A Bachelor's Degree in a scientific or technical field such as Biology, Chemistry, Engineering, or a related discipline, OR Certification in Medical Technology or Quality Management.

• At least 5 years of experience in the pharmaceutical, medical device, diagnostics, or another highly regulated industry.

• Comprehensive understanding of Good Manufacturing Practices (GMP), Quality Systems, and regulatory obligations.

• Experience in conducting internal, supplier, or external audits.

• Proven capability to influence stakeholders and drive quality enhancements across multiple functions.

• Certified Auditor qualification or an equivalent auditing certification is preferred.

• Background in the In Vitro Diagnostics (IVD) industry is preferred.

• Familiarity with medical device software is highly desirable.

• Experience in supporting global regulatory inspections and compliance initiatives.

• Willingness and flexibility to travel internationally up to 65% of the time.

• Excellent communication, analytical, and problem-solving abilities.

• Capability to work independently while effectively collaborating with global teams.

• Successful completion of a pre-employment medical examination, including drug and alcohol screening, is required as a condition of employment.

🏝️ Benefits

• Pre-employment medical examination, including drug and alcohol screening.

• Opportunity to engage with diverse global teams.

• Chance to identify compliance risks and impact quality improvements.

• Opportunities for international travel.

• Equal opportunity workplace that promotes diversity.