Senior Auditor, Supplier Audit & Compliance

AbbVie; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

AbbVie seeks an experienced Quality Auditor to lead comprehensive audits of third-party providers and manufacturers, ensuring compliance with global regulatory requirements. The role includes guiding audit teams, coordinating with cross-functional partners, and maintaining audit programs that support new product development.

Candidates should have 8+ years in quality assurance or auditing, with strong knowledge of GMP and device regulations; ASQ certifications are valued.

Qualifications

• Bachelor’s degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering).
• 8+ years total experience, including 3+ years in compliance or auditing.
• Experience with international GMP and Device regulatory standards (US FDA, EU, MDR/IVDR).
• Quality Assurance auditing experience preferred; Pharmaceutical/Device manufacturing experience preferred.
• ASQ certification (CQM and/or CQA) desirable.

Responsibilities

• Carry out external supplier audits for compliance of systems, facilities, and processes per applicable regulations and company specs.
• Provide audit observations and review corrective actions to verify effectiveness and maintenance.
• Plan and conduct audits independently; maintain and update the audit schedule.
• Lead cross-functional teams, mentor others, and escalate issues as needed.
• Provide guidance on GxP regulations to audit teams and internal stakeholders.

Skills

Auditing

Regulatory knowledge

Leadership

Communication

Cross-functional collaboration

Education

Bachelor's degree in technical or scientific field

Job description

Purpose:

Primarily responsible for carrying out comprehensive quality system audits of third-party service providers and manufacturers for compliance with applicable global regulatory requirements. Responsible for providing quality

consultation, training, auditing and coordination of projects necessary to maintain and improve the quality of new product development programs worldwide

Responsibilities:

• Carry out job duties independently, including interpret, explain and apply applicable current regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies.
• Independently plan and conduct external supplier audits assessing compliance of systems, facilities, and processes per applicable regulations and the company specifications.
• Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained.
• Assist in maintaining approved supplier list, global audit schedule and participate in supplier management processes (e.g. Management Review, Supplier Change Notifications, etc.).
• Provide guidance and training on GxP regulations and guidelines to audit team members and internal business partners.
• Assist on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers.
• Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities.
• Expected to elevate any issues to management, as necessary, in meeting these responsibilities.
• Leads goals with cross-functional or broader scope. Resolves project team issues with minimal oversight.
• Participates in strategic initiatives to improve compliance to regulatory requirements and standards.
• Collaborate with the company Operations in coordinating and conduct of joint audits.
• Ensures audits are conducted according to the annual audit schedule.

This is an experienced level compliance position that reports to the Director RDQA External Partners Quality Audit or designee. This individual is expected to identify and resolve problems through effective interpersonal skills. The incumbent will work effectively independently or as a team, mentor others, and also be an effective cross-functional team leader. Must be able to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas.

• Bachelor’s degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering).
• Demonstrated strong leadership competencies, proficient level of technical capabilities, and independence. Proven track record utilizing core & technical competencies.

• 8+ years’ total experience, including 3+ years in compliance or auditing role.
• Sufficient exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics related industries and thorough understanding of international GMP and Device regulatory standards (e.g. US FDA, EU, MDR/IVDR, etc.).
• Quality Assurance auditing experience (preferred)
• Pharmaceutical/Device Manufacturing experience (preferred)
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ)
• Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA))

the company 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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

About the companythe company'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about the company, please visit us at . Follow @the company on LinkedIn,Facebook, Instagram, X and YouTube.

Originally posted on Himalayas