Director, Manufacturing QA

About the Role

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 external agency regulations worldwide. Scope of responsibility includes 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 manufacturers, intermediates, and drug products.

Acts as the principal quality global supply chain representative with external manufacturing businesses. Builds and maintains relationships with Third Party Manufacturer (TPM) Operations, TPM Business Alliance, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and Science & Technology (S&T) to align strategic initiatives. Develops regulatory strategies for brands with Regulatory Affairs.

Responsibilities

• Develop and lead a quality professional team responsible for assigned products’ transfer activities and end-to-end product quality, conforming to worldwide standards and regulations throughout the New Product Introduction (NPI) supply chain and departmental budget.
• Lead Product Quality Assurance Transfer Managers to develop strong relationships with Third Party Manufacturers, AbbVie plants, affiliates, and other functional groups. Ensure understanding of each project’s quality, compliance, and organizational resource needs, aligning roles and responsibilities.
• Ensure delivery of all quality elements needed to facilitate new product launches, including Third Party Manufacturers that provide products directly to distribution centers or to AbbVie domestic and international plants for further manufacturing, packaging, and/or testing.
• Serve as a core team member or strategic programs lead for initiatives 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. Escalate medium and high-risk events to AbbVie management.
• 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 legal supply agreements, contracts, and letters of intent to ensure appropriate quality, compliance, and regulatory aspects are met for the products and services covered.
• Manage and approve organizational actions, such as Quality and Technical agreements, as a representative of AbbVie within the legal boundaries of these documents.
• Complete management reviews with assigned TPMs to identify and address quality, operational, and organizational issues.
• Interface with the Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans. Review audit observations and responses, and maintain corrective action timetables.
• Provide support for quality audits, initial site approvals, and due diligence activities.
• Direct and manage pre-approval inspection readiness related to third-party manufacturers to ensure regulatory approvals are obtained without delays to market entries.
• Actively participate and interface directly or indirectly with regulatory agencies such as the FDA, EMA, MHRA, ANVISA, and MoH for pre-approval inspections.
• Function as the main Quality liaison between Third Party Manufacturers (TPMs) and AbbVie Operations in support of commercial operations, new product introductions, and product transfers.
• Negotiate with external companies’ upper management to maintain consistent quality and expectations that minimize compliance risks while balancing operational costs to provide AbbVie with agreed services.
• Establish and maintain relationships and open communication with TPMs, AbbVie plants, affiliates, and other functional groups (R&D, Regulatory, Purchasing, etc.) to define roles, 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 TPMs’ quality organizations to maintain consistent quality and expectations that minimize compliance risks while balancing operational costs.
• Prioritize programs, initiatives, and problem-solving with consideration for impact on timelines, resources, and conflicting priorities.

Qualifications

• Bachelor’s Degree in a relevant Life Science, Pharmacy, or Engineering is required. Graduate degree preferred.
• Technical or analytical background required for problem resolution related to technical, quality, product, or engineering issues.
• Total combined experience of 15+ years in the pharmaceutical, biologics, device, or chemical industry, with a minimum of 5 years in Manufacturing and 4 years in QA, R&D, and/or S&T.
• Minimum of 6 years of management and supervision experience.
• Minimum of 5 years’ experience in a direct plant pharmaceutical setting role.
• Required regulatory inspection experience with direct interaction with regulatory inspectors.
• Expert knowledge and comprehensive understanding of 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).
• Ability to operate within an environment requiring a high degree of urgency, positive interpersonal skills, and the ability to manage multiple complex tasks simultaneously.
• Capable of analyzing data, facts, and informed opinions to direct the development of effective action plans and problem-solving without the benefit of precedent.
• Ability to understand and overcome differing cultural and language obstacles to provide solutions that satisfy corporate, divisional, regional, and local objectives for managing action plans.
• Strong leadership skills required to manage professional staff and effectively interface with senior leaders both internally and externally.
• Capacity to perform as a leader, team member, and individual contributor.
• Experience with requirements for third-party external manufacturing.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.