Associate Director, QA Operations
Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Acts as the primary quality representative for the global supply chain pertaining to external manufacturing business relationships and builds and maintains relationships with TPM Operations, Supplier Quality Management, TPM Business Alliance, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and S&T to ensure alignment on strategic programs and initiatives.
- 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. Primary driver for the quality and compliance.
- 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.
- 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.
- 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.
- Total combined years of experience. Minimum of 10+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceuticals/device setting. Required regulatory inspection experience with direct interaction with regulatory inspectors. Direct Plant experience in a pharmaceutical setting with a minimum of 5 years preferred.
- 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.
- A wide range of activities are undertaken from long term strategy development to short term crisis management. The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives to effectively manage the action plans that will resolve the issues.
- Experience working the requirements for third party external manufacturing.