Associate Director, Product Quality

Summary

Join AbbVie as a Quality Assurance professional responsible for ensuring the quality and compliance of pharmaceutical and biologic products across the global supply chain. You will lead a team, develop global quality strategies, and act as the primary quality contact for third-party manufacturers. This role requires strong leadership, problem-solving skills, and experience in regulatory compliance. You will collaborate with various internal and external stakeholders to ensure on-time delivery and meet regulatory requirements. The position offers opportunities for strategic leadership and involvement in key programs. AbbVie is committed to diversity and inclusion.

Requirements

• Bachelor’s Degree in relevant Life Science or other technical required
• Graduate degree desired
• Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues
• Minimum of 10+ years of experience in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting
• Required regulatory inspection experience with direct interaction with regulatory inspectors
• Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (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)
• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, team members and individuals
• Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required
• Experience working the requirements for third party external manufacturing

Responsibilities

• Lead a team of Quality professionals for product transfer activities and direct cross-functional team members to achieve on-time quality deliverables, high customer value, and profitable results
• Ensures delivery of all quality elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centres, or to AbbVie domestic and International plants for further packaging and/or testing
• Develops Global Product Quality Assurance strategy and implements agreed strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities
• Primary Quality contact between third party manufacturers, R&D and AbbVie Operations in support of commercial operations, New Product Introductions and product transfers
• Supports the regulatory filings and marketing authorization dossiers by developing and/or reviewing of chemistry, manufacturing and controls documents and Drug Master files/Certificate if suitability of monographs of the Ph. Eur. Documents
• Lead QA contact with AbbVie Affiliates and Regulatory to prepare submissions and participates in responses to questions received by Regulatory authorities
• Makes key decisions on product quality, compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management
• Leads the collection, verification and improvement of Quality metrics used for management review in partnership with senior leadership to develop a clear picture of overall compliance state and linking this to local / global project implementation
• Leads product quality team to support development of the legal supply agreements, contractors or letters of intent to ensure that the appropriate quality, compliance and regulatory aspects are met for the products and services covered and manage the organization’s actions within the legal boundaries of these documents
• Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled
• Establishes and maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns
• Supports the management of exception documents and CAPA
• Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service
• Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities
• Manages team interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable
• Provides support for quality audits, initial site approvals and due diligence activities
• Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries
• Core team member or lead of strategic programs; including Brand Teams, New Product Introductions, Product Transfers, Global Strategic Sourcing, Due Diligence, Site Selection, and Approvals and Continuous Improvement
• Provides support and interfaces directly/indirectly with the FDA, EMA, MHRA, ANVISA, MoH, etc. for pre-approval inspections
• Responsible for the strategic leadership of one or more division level quality systems to include SOP Development, Maintenance and Training
• Develops, and/or implements the systems across AbbVie operations to assure consistent, high quality products and compliance with worldwide regulatory requirements
• Develops new and improved Quality systems within Operations
• Influences the decision making process to ensure quality requirements are included when improvement initiatives take place

Preferred Qualifications

Direct Plant experience in a pharmaceutical setting with a minimum of 5 years preferred

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs