Product Quality Senior Manager

About the Role

Responsible for the quality of assigned products, which may include small molecule pharmaceuticals, biologics, combination products, and medical devices. Ensures business objectives are met regarding on-time delivery of product while maintaining compliance with local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), intermediates, or drug products produced by AbbVie plants, third-party manufacturers, in-licensing relationships, or co-marketing relationships. Develops regulatory strategies for product brands in collaboration with Regulatory Affairs.

Responsibilities

• Maintains primary quality lead with management oversight for project activities and team members (within and outside AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results.
• Drives quality and compliance aspects of product transfers and organizational optimization.
• Participates in developing and implements global Product Quality Assurance strategy for pharmaceuticals, biologics, devices, and combination products produced at AbbVie plants and third-party manufacturing (TPM) facilities.
• Performs final quality release of manufactured product lots prepared by third-party manufacturers.
• Makes recommendations for key decisions on product quality, compliance, and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products; elevates medium and high-risk events to AbbVie management.
• Ensures alignment of Quality and Technical Agreements with legal contracts and fulfillment of commitments.
• Facilitates resolution when commitments in quality and technical agreements are not met.
• Establishes and maintains relationships with third-party manufacturers, AbbVie plants, affiliates, and other functional groups to clarify roles, identify projects/issues, and provide guidance on quality concerns.
• Communicates and negotiates with external companies' quality organizations to maintain consistent quality standards while balancing operational costs.
• Prioritizes programs, initiatives, and problem-solving considering timelines, resources, and conflicting priorities.
• Interfaces with the Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans; reviews audit observations, responses, and maintains corrective action timetables.
• Provides support for quality audits, initial site approvals, and due diligence activities.
• Leads and manages pre-approval inspection readiness for third-party manufacturers to ensure regulatory approvals without delays.
• Contributes to Quality Assurance elements for new product launches, including third-party manufacturers providing products directly to distribution centers or AbbVie plants for further packaging/testing.
• Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events) issues.
• Supports management of exception documents and Corrective and Preventive Actions (CAPA).
• Completes management reviews with assigned third-party manufacturers to address quality, operational, and organizational issues.
• Obtains and reviews summaries of Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from third-party manufacturers to ensure accuracy, completeness, timeliness, and trend identification.

Qualifications

• Bachelor’s Degree in a relevant Life Science, Engineering, or other technical discipline required; technical or analytical background for problem resolution related to technical, quality, product, or engineering issues.
• Minimum of 8+ years of total combined experience, with at least 3 years in Quality Assurance Operations Management and 5+ years in Operations, Research and Development, Regulatory, or Consulting.
• Direct manufacturing plant experience in a pharmaceutical setting preferred.
• Comprehensive knowledge/expertise in biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets, caplets, suspensions, granulations, soft elastic capsules, gel caps, extended-release products, coating solutions, and/or active pharmaceutical ingredients).
• Strong background in quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation.
• Experience with FDA and other regulatory agency interactions and inspections.
• Familiarity with requirements for third-party external manufacturing.
• Strong analytical and problem-solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as a leader.

Benefits

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