Lead Compliance Auditor
2 weeks ago
About Abbott Laboratories
Abbott Laboratories is a leading entity in the healthcare sector, dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of innovative technologies encompasses diagnostics, medical devices, nutritional products, and branded generic medicines. With a workforce of 114,000 professionals, we are committed to serving communities in over 160 countries.
Why Work at Abbott?
At Abbott, you will engage in meaningful work, experience personal and professional growth, and enjoy a balanced life. We offer:
- Opportunities for career advancement within a global organization.
- Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
- A robust retirement savings plan with significant employer contributions.
- Tuition reimbursement and programs designed to assist with student debt.
- A workplace recognized globally for its positive culture and diversity.
Position Overview
This role is based at Abbott's corporate headquarters or any designated location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is integral to our corporate strategy, conducting thorough audits of Quality Systems across all manufacturing facilities.
Ensuring product quality and adherence to regulatory standards is crucial for maintaining consumer safety, protecting Abbott's reputation, and sustaining market confidence. This position carries substantial responsibilities with a wide-reaching impact across AQR and all divisions, ensuring that executive management is informed of compliance risks and regulatory obligations.
As a Senior Global Compliance Auditor, you will spearhead Quality System audits and evaluations in accordance with applicable regulations, standards, and Abbott protocols. Your role will involve collaborating across divisions to consolidate insights from compliance audits and regulatory trends that may influence various sectors.
Key Responsibilities
- Independently direct, plan, and implement audit policies and programs across the organization.
- Lead comprehensive audits at Abbott manufacturing facilities.
- Draft detailed audit reports for executive review.
- Effectively communicate risks and their implications to all management levels.
- Provide professional training on compliance and quality matters essential to Abbott's operations.
- Develop a risk-based audit framework.
- Travel domestically and internationally as required, up to 50% of the time.
Qualifications
- A four-year degree in a scientific, technical, or compliance-related field, or equivalent experience.
- Certification as a lead auditor for Quality System audits.
- Strong communication, critical thinking, and decision-making abilities.
- Proficient time management skills.
Preferred Experience
- Over 8 years in Quality Assurance or Engineering within the pharmaceutical, device, or nutritional sectors.
- Experience with design controls and validations is advantageous.
- Familiarity with product software development and management is a plus.
- One to two years in Compliance or Regulatory Affairs is preferred.
Abbott is committed to employee diversity and is an Equal Opportunity Employer. We encourage you to explore a career with us, where you can contribute to meaningful work and build a fulfilling future.
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