Auditor, QA Compliance

Amsterdam, NH

• Function: Operations
• Job Type: Full-time

Job ID: R00130945
Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
Job Description
We are seeking an experienced Audit and Compliance Auditor to join our Global Supplier Audit team in Europe (can be located across Europe). As a key member of our quality team, you will evaluate suppliers and ensure the highest quality for our products and patients. Suppliers may include API suppliers, contract labs, excipient suppliers, commodity suppliers, medical devices, logistic providers, and third-party manufacturers. Your work in GMP compliance and quality will ensure that activities are performed and documented in accordance with AbbVie policies, procedures, and applicable quality and regulatory requirements, assuring the quality, effectiveness, and safety of our products.

Qualifications

• Bachelor’s Degree preferably in a technical or scientific area (e.g., Chemistry, Pharmacy, Biology, Microbiology, Engineering) or equivalent industry experience (at least 4 years) in relevant fields such as pharmaceutical, medical device, biologics, cosmetics, or aesthetics industries.
• Technical background with knowledge of GMP regulations and quality systems; ASQ certification is desired.
• Minimum of 6+ years of total relevant experience, including at least 4+ years in Quality Assurance with some project management experience and 2+ years in compliance auditing.
• Strong understanding of quality management principles and experience in compliance auditing.
• Excellent oral and written communication skills, with effective interpersonal and organizational skills.
• Fluent in English, including reading, writing, and verbal communication

• Perform Supplier QA audits based on skill and development plans.
• Serve as a newer and developing auditor, supporting audits in alignment with training and development strategies.
• Execute and support audits to ensure supplier compliance with regulatory standards and AbbVie specifications.
• Coordinate and communicate supplier QA audit activities, where applicable.
• Provide feedback through audit observations and review corrective actions to ensure proper implementation and maintenance by suppliers.
• Support projects and initiatives as needed for development and improvement of compliance with regulatory standards.
• Collaborate with suppliers to address compliance issues and enhance their understanding of regulatory requirements.
• Participate in developing and maintaining audit schedules, audit plans, and reporting tools.
• Contribute to continuous improvement efforts within the Supplier Audit Team to optimize audit processes and ensure high-quality outcomes.
• Stay informed about changes in regulations and industry best practices to support supplier compliance efforts.

Qualifications

• Bachelor’s Degree preferably in a technical or scientific area (e.g., Chemistry, Pharmacy, Biology, Microbiology, Engineering) or equivalent industry experience (at least 4 years) in relevant fields such as pharmaceutical, medical device, biologics, cosmetics, or aesthetics industries.
• Technical background with knowledge of GMP regulations and quality systems; ASQ certification is desired.
• Minimum of 6+ years of total relevant experience, including at least 4+ years in Quality Assurance with some project management experience and 2+ years in compliance auditing.
• Strong understanding of quality management principles and experience in compliance auditing.
• Excellent oral and written communication skills, with effective interpersonal and organizational skills.
• Fluent in English, including reading, writing, and verbal communication.

Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.htm