Product Quality Senior Manager

About the Company

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, and neuroscience—and products and services in our Allergan Aesthetics portfolio.

About the Role

Responsible for the quality of assigned products, which may include small molecule pharmaceuticals, biologics, combination products, and medical devices, to ensure business objectives are met regarding on-time delivery while assuring 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, in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands.

Responsibilities

• Maintains the primary quality lead with management oversight for project activities and team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results.
• Primary driver for the quality and compliance aspects of product transfers and organization optimization.
• Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device, and combination products produced at AbbVie plants as well as third-party manufacturing (TPM) facilities. Implements agreed strategy.
• Performs final quality release of manufactured product lots for products 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 that commitments are fulfilled; facilitates resolution where they are not.
• Establishes and maintains relationships with third-party manufacturers, AbbVie plants, affiliates, and other functional groups to clarify roles, identify projects and issues, and provide guidance on quality concerns.
• Communicates and negotiates with external companies’ quality organizations to maintain consistent quality and balance compliance risks with operational costs.
• Prioritizes programs, initiatives, and problem-solving with consideration for 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 and responses, and maintains corrective action timetables.
• Provides support for quality audits, initial site approvals, and due diligence activities; leads pre-approval inspection readiness for third-party manufacturers.
• 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.
• 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 required for problem resolution with technical, quality, product, or engineering-related issues.
• Minimum 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 is preferred.
• Comprehensive knowledge of 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 quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background.
• Experience with FDA and other regulatory agency interactions and inspections.
• Familiarity with requirements for third-party external manufacturing.
• Ability to operate in a high-urgency environment with strong analytical, problem-solving, and interpersonal skills; capable of managing multiple complex tasks simultaneously.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
• Eligibility to participate in long-term incentive programs.