Responsible for overall quality of AbbVie products including small molecule pharmaceuticals and/or biologics, combination products, and medical devices—complying with delivery time objectives; local, divisional, and corporate policies; and ext. agency regulations worldwide. Scope of responsibility can also include business processes supporting new product introduction, product monitoring, or post-market quality systems. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), produced by AbbVie or third-party manufacturer Intermediates/Drug Products. Acts as the principle, quality, global supply chain rep. with external manufacturing businesses. Builds and maintains relationships with TPM Operations, TPM Business Alliance, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and S&T to align strategic initiatives. Develop regulatory strategies for brands with Regulatory Affairs. Grade depe
Responsibilities
Develop and lead a quality professional team responsible for assigned products’ transfer activities and end-to-end product quality—conforming to worldwide standards/regulations throughout the NPI supply chain & departmental budget. Lead Product Quality Assurance Transfer Mngr.s to develop strong relationships with Third Party Manufacturers, AbbVie plants, affiliates, & other functional groups. Help them understand each project’s quality, compliance, & org. resource needs; & align roles and res
- Ensure 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 manufacturing, packaging and/or testing.
- Core team member or strategic programs lead; including Pipeline Teams, New Product Introductions, Governance Process, CMC Leadership Team, Product Transfers, Specification Approval Team, Regulatory Starting Material Core Team, Global Strategic Sourcing, Due Diligence, and Site Selection. Make primary 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 mngmnt.
- Develop and implement a global Product Quality Assurance strategy to support quality systems or product requirements associated with pharmaceuticals, biologics, devices and combination products manufactured at AbbVie plants or third party manufacturing (TPM) facilities. Provide a Quality Assurance perspective during new product development and address resolution of quality and compliance issues.
- Support development of the legal supply agreements, contracts and letters of intent to ensure the appropriate quality, compliance, and regulatory aspects are met for the products and services covered. Manage and approve organizations actions—like Quality and Technical agreements— as a representative of AbbVie, within the legal boundaries of these documents. Approves negotiated quality and technical agreement as a representative of AbbVie.
- Key decision maker on product quality, compliance, and regulatory conformance issues for sterile, biological, liquid, solids and/or device products. Complete management reviews with assigned TPMs that identify and address quality, operational, and organizational issues. Interface 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.
- Provide support for quality audits, initial site approvals and due diligence activities. Direct and manage pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries. Actively participates and interfaces directly/indirectly with the FDA, EMA, MHRA, ANVISA, MoH, etc. for pre-approval inspections.
- Function as main Quality liaison between Third Party Manufacturers (TPMs) and AbbVie Operations in support of commercial operations, new product introductions, and product transfers. Negotiates with external companies’ upper management 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.
- Establish and maintain relationships and open communication with Third Party Manufacturers (TPMs), AbbVie plants, affiliates and other functional groups (R&D, Regulatory, Purchasing, etc.) to define roles and responsibilities and identify potential projects and issues. Obtain an in-depth understanding of the quality, compliance, and resource needs at each transfer site. Provide quality oversight and guidance for successful validations (processes, test methods, etc.) and qualifications.
- Communicate and negotiate with the TPM’s 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. Prioritize programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.