Aseptic Product Quality Manager

Aseptic Product Quality Manager

Responsibilities

• Lead quality oversight for project activities and team members (internal and external) to ensure on‑time quality deliverables and profitable results.
• Support Eye Care Quality Assurance Third Party Manufacturer teams with investigation and hands‑on assessment of aseptic events.
• Drive implementation of aseptic best practices at TPM based on AbbVie standards and technological advancements.
• Perform final quality release of manufactured product lots produced by Third Party Manufacturers.
• Make recommendations on key decisions regarding product quality, compliance, and regulatory conformance for sterile, biological, liquid, solids, device products; elevate medium and high risk events.
• Maintain alignment of Quality and Technical Agreements with legal contracts and ensure commitments are fulfilled.
• Establish and maintain relationships with Third Party Manufacturers, AbbVie plants, affiliates, and cross‑functional teams to identify projects and resolve quality concerns.
• Communicate and negotiate with external quality organizations to maintain consistent quality levels and manage compliance risks while balancing cost.
• Interface with the Quality Assurance audit team to develop audit plans, due diligence, inspection readiness plans, and review audit observations and corrective actions.
• Support quality audits, initial site approvals, and due diligence activities; lead pre‑approval inspection readiness.
• Contribute to Quality Assurance elements for new product launches involving Third Party Manufacturers.
• Coordinate follow‑up on compliant trend investigations and manage exception documents and corrective/preventive actions.
• Conduct management reviews with third party manufacturers to address quality, operational, and organizational issues; review annual product reports.

Qualifications

• Bachelor’s Degree in Life Sciences or related technical discipline, or equivalent experience.
• 7+ years of combined experience, including at least 5 years in Quality Assurance/Aseptic Manufacturing Operations Management and 3 years in Operations, Research & Development, or Consulting.
• Knowledge of aseptic manufacturing and biological/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 analytical and problem‑solving skills, ability to manage multiple complex tasks, effective interpersonal communication, and leadership capability.

Location & Remote Work

Role can be worked from any AbbVie site globally.

Equal Opportunity Statement

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.