Associate Director, Global Quality and Compliance Excellence

Role Summary

Associate Director, Global Quality and Compliance Excellence. Leads preparedness for regulatory inspections and audits across AbbVie sites globally, driving a quality culture and ensuring readiness for inspections of small molecule pharmaceuticals, biologics, combination products, medical devices, tissue, and cosmetics.

Responsibilities

• 50-75% Travel Required - can be located anywhere in the US due to this travel requirement.
• Leads preparedness for regulatory inspections by ensuring AbbVie sites are compliant with global standards and regulations, conducting mock audits, and coaching site leadership on how to address opportunities identified.
• Coaches site leadership and employees during external regulatory inspections and audits to empower successful audit outcomes and ensure regulatory approvals are obtained.
• Develops updated audit plans, due diligence plans, inspection readiness plans, audit observations and responses, and ensures corrective actions are appropriate.
• Provides 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.
• Closely collaborates 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
• Ensures the delivery of all quality elements needed to facilitate new product launches, including Third Party Manufacturer‚Äôs that provide products directly to distribution centers, or to AbbVie domestic and international plants for further packaging and/or testing.
• Provides technical and regulatory guidance to compliance-related events across the network (i.e. observations, significant events), a key component of AbbVie‚Äôs overall compliance strategy
• Collaborates with Quality Centers of Excellence in reviewing regulatory intelligence and assessing company vulnerabilities against regulatory agency inspection findings
• Serves as a key stakeholder for cross-functional teams to ensure we as a company achieve on-time compliance and quality deliverables, high customer value, and profitable results.
• Ensures business objectives are met while maintaining compliance with local, divisional, and corporate policies as well as global external agency regulations.

Qualifications

• Bachelor‚Äôs Degree in relevant Life Science or other technical area required. Graduate degree desired. Advanced technical and analytical expertise required for problem resolution of technical, quality, product, and/or engineering related issues.
• 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.
• Experience working with third party external manufacturers preferred.
• 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.
• Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required
• Ability to navigate global structure with various ways of working and provide consistent leadership when faced with obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives.
• 50-75% travel required

Skills

• Quality assurance and control
• Regulatory compliance and inspections
• Auditing and mock audits
• Regulatory intelligence and vulnerability assessment
• Cross-functional collaboration and leadership
• Strategic planning and inspection readiness
• Vendor and third-party manufacturer management
• Problem solving and analytical thinking