Global Quality and Compliance Lead
6 days ago
We are seeking a highly experienced and skilled professional to join our team as a Director of Global Quality and Compliance. This role will be responsible for leading the development and maintenance of a quality culture across our global network, ensuring compliance with global standards and regulations.
Key Responsibilities- Regulatory Inspection Preparedness: Ensure all AbbVie sites are compliant with global standards and regulations, conduct mock audits, and coach site leadership on how to address opportunities identified.
- Coaching and Guidance: Coach site leadership and employees during external regulatory inspections and audits to empower successful audit outcomes and ensure regulatory approvals are obtained.
- Audit Planning and Execution: Develop updated audit plans, due diligence plans, inspection readiness plans, audit observations and responses, and ensure corrective actions are appropriate.
- Quality Culture Development: Provide consultation, guidance, and strategic input to site and global leadership teams on initiatives that enable them to set priorities, advance quality culture, and maintain sites in an inspection-ready state while sustaining compliance.
- Collaboration and Communication: Closely collaborate with AbbVie plant leadership, global functional groups, Third Party Manufacturers, etc., to maintain roles and responsibilities, identify potential project gaps, obtain an in-depth understanding of the quality, compliance, and resources needs at each site, and provide guidance on quality concerns.
- Quality Element Delivery: Ensure the delivery of all quality elements needed to facilitate new product launches, including Third Party Manufacturer's that provide products directly to distribution centers, or to AbbVie domestic and international plants for further packaging and/or testing.
- Regulatory Guidance: Provide technical and regulatory guidance to compliance-related events across the network (i.e. observations, significant events), a key component of AbbVie's overall compliance strategy.
- Regulatory Intelligence Review: Collaborate with Quality Centers of Excellence in reviewing regulatory intelligence and assessing company vulnerabilities against regulatory agency inspection findings.
- Business Objectives and Compliance: Ensure business objectives are met while maintaining compliance with local, divisional, and corporate policies as well as global external agency regulations.
- Education: Bachelor's Degree in relevant Life Science or other technical area required. Graduate degree desired.
- Experience: 10+ years of experience in Quality Assurance, Regulatory, Operations, or Technical Support in a pharmaceutical or medical device setting required. Experience working in a regulatory agency preferred; direct interaction with regulatory inspectors required. 6+ years of direct Plant leadership in a pharmaceutical setting preferred.
- Skills and Abilities: Strong leadership background with an ability to make agile and decisive decisions. Comprehensive understanding of biological and/or pharmaceutical (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended-release products, coating solutions, and/or active pharmaceutical ingredients), medical devices or combination products technologies. Strong influential skills and ability to effectively operate in a fast-paced, complex organization, apply strong analytical problem-solving skills, and demonstrate strong interpersonal skills.
- Travel Requirements: 50-75% travel required.
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