Senior GxP Compliance Auditor (m/f)
The Senior GXP Auditor provides leadership and direction and performs evaluations for compliance with worldwide regulatory requirements. The position provides relevant and constructive evaluation of internal R&D systems and external suppliers that provide materials and services to AbbVie. This includes device manufacturers, API suppliers, third party manufacturers, contract labs, contract research organizations, and service providers. The individual is expected to identify and resolve problems, through effective interpersonal skills. The incumbent will work effectively independently, mentor compliance auditors, and also be an effective crossfunctional team leader. Their leadership, direction and execution in the area of compliance and quality assures that activities are performed and documented in accordance with applicable worldwide quality and regulatory requirements to assure quality, effectiveness and safety of our clinical materials and drug development activities.
- Assess compliance of systems, facilities and procedures per applicable regulations through audits and assessments, assuring compliance to worldwide regulatory requirements and AbbVie policies, procedures and protocols.
- Provide feedback in the form of audit observations, formulate recommendations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained.
- The major responsibilities of this position are primarily focused on R&D GXP internal systems and key suppliers whose processes are complex, comprehensive and critical to the business.
- Participate in technically complex and strategic crossfunctional projects.
- Support the implementation of strategic initiatives to improve compliance to current and new regulatory requirements and standards.
- The position must achieve a difficult balance of involvement, independence and objectivity.
- Collaborate with GXP functional areas and assist in the resolution of internal system and external supplier quality issues.
- The position provides an active role within the corporation as experts in GXP requirements. The strategic focus is for early detection and prevention, followed by correction of issues.
- Bachelor’s or Master´s degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 5 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries.
- Thorough understanding of international medical device and GMP regulations. Must have a technical background and requires a thorough understanding of the audit process and an extensive knowledge of worldwide requirements related to GMP 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.
- The individual must have excellent oral/written communications skills. Personal skills needed include interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational/administrative skills and sound judgment.
- Persuasive, effective communication skills are essential with an ability to work effectively outside of the company and across divisional and technical areas.
- 4+ years in Quality Assurance with some management experience preferred and two more years in another function in the pharmaceutical, medical device/nutritional or related industry. Two years in compliance/auditing or regulatory affairs is desirable. Total combined experience expected to be at least 8 years.
- ASQ certification desired.
We are looking forward to your application. Please provide information about your salary expectations and possible start date in your motivation letter.
An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.