Audit Program Manager

🔥 0 minutes ago

🌐 Ireland, Spain, +2 more countries – Remote

🇮🇪 Ireland – Remote 🇪🇸 Spain – Remote 🇮🇹 Italy – Remote 🇩🇰 Denmark – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

📋 Program Manager

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Abbott

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1888

🏥 Healthcare

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare • Healthcare Insurance • Biotechnology

Abbott is a global healthcare company committed to advancing medical technologies and improving lives around the world. It offers a broad range of leading products in diagnostics, medical devices, nutrition, and branded generic medicines. Abbott's innovations such as the FreeStyle Libre glucose monitoring systems and BinaxNOW rapid antigen tests are transforming diabetes management and COVID-19 response. Through its partnerships and initiatives, Abbott aims to foster health equity, improve access to healthcare, and address critical health challenges like malnutrition and infectious diseases. Abbott is also dedicated to sustainability and social responsibility, striving to make life-changing technologies accessible and affordable.

📋 Description

• Plan, schedule, and conduct internal audits across Abbott Diagnostics manufacturing and commercial affiliate sites • Perform supplier and third-party manufacturer audits to evaluate regulatory and quality compliance • Execute audits to standards consistent with regulatory authority inspections • Identify compliance risks and quality system gaps • Provide guidance and recommendations for corrective and preventive actions • Support sustainable quality system improvements across sites • Monitor emerging regulatory trends and assess business impacts • Support inspection readiness initiatives across Abbott Diagnostics sites • Participate as a subject matter expert during audits and inspections • Deliver compliant solutions to complex quality and regulatory issues • Develop and maintain internal audit schedules • Generate audit metrics and compliance reports for site and divisional leadership • Communicate audit findings and recommendations • Maintain audit documentation and records in accordance with regulatory requirements • Lead cross-functional quality and compliance projects • Champion initiatives and drive change across multiple sites and functions • Collaborate with global stakeholders to strengthen quality systems and compliance performance

🎯 Requirements

• Bachelor's Degree in a scientific or technical discipline such as Biology, Chemistry, Engineering, or a related field, OR Certification in Medical Technology or Quality Management • Minimum of 5 years' experience within the pharmaceutical, medical device, diagnostics, or another highly regulated industry • Strong understanding of Good Manufacturing Practices (GMP), Quality Systems, and regulatory requirements • Experience conducting internal, supplier, or external audits • Demonstrated ability to influence stakeholders and drive quality improvements across multiple functions • Certified Auditor qualification or equivalent auditing certification preferred • Experience within the In Vitro Diagnostics (IVD) industry preferred • Knowledge of medical device software highly desirable • Experience supporting global regulatory inspections and compliance programs • Willingness and flexibility to travel internationally up to 65% of the time • Strong communication, analytical, and problem-solving skills • Ability to work independently while collaborating effectively with global teams • Successful completion of a pre-employment medical examination, including drug and alcohol screening, required as a condition of employment

🏖️ Benefits

• Pre-employment medical examination, including drug and alcohol screening • Opportunity to work with diverse global teams • Opportunity to identify compliance risks and influence quality improvements • International travel opportunities • Equal opportunity workplace supporting diversity