Senior Project Manager, QA

Role Summary

Senior Project Manager, QA – Responsible for quality of assigned products to ensure on-time delivery while ensuring compliance to policies and external regulations. Develops regulatory strategies for product brands in collaboration with Regulatory Affairs.

Responsibilities

• Maintains the primary quality lead with management oversight for project quality activities and team members to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for quality, risk management, and compliance aspects of product transfers and organization optimization.
• Leads 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 facilities. Implements the strategy.
• Makes key decisions on product quality and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium/high risk events to management. Aligns Quality and Technical Agreements with contracts and ensures commitments are fulfilled; facilitates resolution when needed.
• Establishes and maintains relationships with Third Party Manufacturers, AbbVie plants, affiliates and other groups to define roles, identify projects/issues, understand quality needs at each site, and provide guidance on quality concerns. Primary quality contact with Supply Chain and R&D for new products at TPMs.
• Communicates and negotiates with external quality organizations to maintain consistent quality while balancing costs. Prioritizes programs and problem solving considering timelines, resources, and conflicts.
• Interfaces with Quality Assurance audit team to develop audit/due diligence/inspection readiness plans, review observations, and maintain corrective action timetables. Supports quality audits, site approvals, due diligence, and pre-approval inspection readiness for TPMs.
• Manages Quality Assurance elements to facilitate new product launches, including Third Party Manufacturers that supply products to distribution centers or AbbVie plants for packaging/testing. Drives Product Transfer Process from R&D to AbbVie sites.
• Supports management of exception documents and Corrective and Preventive Actions. Coordinates input from technical groups to determine root cause and actions.
• Develops product quality transfer process monitoring metrics. Manages small teams of quality professionals and maintains departmental spend within budget.
• Supports regulatory filings and marketing authorization dossiers by developing/reviewing chemistry, manufacturing and controls documents and Drug Master Files. Works with AbbVie Affiliates and Regulatory to prepare submissions and respond to deficiencies.

Qualifications

• Bachelor‚Äôs Degree in Life Science, Engineering, or related technical discipline. Technical/Analytical background for problem resolution in technical, quality, product, or engineering issues.
• Minimum 8+ years of experience; at least 3 years in Quality Assurance Operations Management; 5+ years in Operations, R&D, Regulatory, or Consulting. Direct pharmaceutical manufacturing plant experience preferred.
• Knowledge of biological/pharmaceutical technologies (sterile, biological, liquids, ointments, devices, tablets/capsules, suspensions, coatings, APIs, etc.).
• Strong QA/quality, manufacturing, lab, regulatory, and/or validation background.
• Experience with FDA and other regulatory agency interactions and inspections.
• Familiarity with third-party external manufacturing requirements.
• Ability to operate in urgent environments with strong analytical and problem-solving skills, effective communication, and multi-tasking capability; leadership and collaboration abilities.

Skills

• Quality Assurance
• Regulatory Compliance
• Product Transfer and Launch
• Audits and Inspections
• Third-Party Manufacturing Management
• Cross-functional Collaboration
• Risk Management