Join our Talent Pipeline for Principal Auditor, Audit & Compliance (Remote)
Join our Talent Pipeline for Principal Auditor, Audit & Compliance (Remote)
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Salary Not Disclosed
1 Vacancy
Job Description
The Principal Auditor Audit & Compliance provides leadership direction and performs comprehensive audits for compliance with US and foreign regulation requirements providing constructive evaluation of quality related systems for AbbVie plants affiliates quality service areas and/or suppliers that provide materials services and products to AbbVie. Their leadership direction and execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality effectiveness and safety of our products. This position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and objectivity.
Responsibilities
- Requires 50-75% Travel
- Assesses compliance of systems facilities and procedures per applicable regulations assuring compliance to regulatory requirements and AbbVie 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 at the supplier or internal AbbVie site. For internal sites formulates recommendations for corrective actions.
- Leads and participates in strategic initiatives to improve compliance to regulatory requirements and standards.
- For supplier auditing primarily focused on key suppliers whose processes are more comprehensive and critical to the business and will include potential participation in audits of AbbVie plants.
- Collaborates with R&D QA to coordinate and conduct joint audits.
- Communicates and coordinates supplier audit activities with internal stakeholders such as procurement SQA EQA manufacturing sites and commercial affiliates as well as external stakeholders
- Ensures audits are conducted according to the annual audit schedule.
- Plays an active role within the corporation as experts in GMP requirements. Strategically focused on early detection and prevention followed by correction of issues.
Qualifications :
- Bachelors Degree preferably in technical or scientific area (Chemistry Pharmacy Biology Microbiology or Engineering) or equivalent industry experience (at least 4 years) with sufficient exposure to pharmaceutical medical device biologics and combination products cosmetics eye care or aesthetics related industries. ASQ certification desired.
- 9 years of total relevant experience including 6 years in Quality Assurance with some management experience preferred and 3 years in the pharmaceutical medical device biotechnology or related industry and 4 years in compliance/auditing or regulatory affairs is desirable.
- Must have a technical background including an understanding of Quality Assurance audit process and knowledge of worldwide requirements related to GM P regulations for quality systems and compliance.
- Must understand a variety of quality/operational systems that support facility product design development production distribution installation support and service and understand the principles of quality management.
- Excellent oral/written communications skills. Must exhibit strong interpersonal skills tact open mindedness maturity tenacity self-reliance organizational/administrative skills and sound judgment.
- Must be able to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas.
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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
