Aseptic Product Quality Associate Director

About the role

The Aseptic Product Quality Associate Director serves as the quality subject matter expert for aseptic manufacturing within the External & Product Quality Assurance Eye Care Global Team. This role provides quality leadership in support of due diligence activities at third-party manufacturers (TPMs/CMOs) and contributes as a key member of cross-functional teams.

Responsibilities

• Lead the Aseptic External & Product Quality Assurance Eye Care Global Team by developing and implementing aseptic strategies that ensure robust product quality assurance.
• Conduct due diligence visits to prospective external partners (TPMs/CMOs) as a member of cross-functional teams.
• Perform hands-on assessments of aseptic manufacturing operations, processes, and controls, while driving the implementation and adoption of aseptic best practices across external partners to strengthen quality systems and operational performance.
• Provide technical quality leadership for aseptic-related investigations, including root cause identification, risk evaluation, and the development of corrective and preventive actions.
• Monitor and evaluate emerging technologies, regulatory expectations, and industry trends related to aseptic manufacturing and contamination control.
• Provide quality oversight of external manufacturing operations to ensure compliance with applicable regulatory requirements and quality standards, while proactively identifying, assessing, prioritizing, and mitigating aseptic risks.
• Deliver strategic input and recommendations to support risk-based decision-making for aseptic manufacturing and external quality operations.
• Build and sustain collaborative relationships with AbbVie internal manufacturing sites, global aseptic teams, and cross-functional stakeholders.
• Support the escalation, communication, and resolution of significant aseptic quality issues that may affect product quality or supply continuity.
• Foster and promote a strong quality culture centered on proactive risk management, continuous improvement, product quality, and operational excellence.

Requirements

• Bachelor’s Degree in relevant Life Science or other technical required. Graduate degree desired. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
• Total combined years of experience. Minimum of 10+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting. Required regulatory inspection experience with direct interaction with regulatory inspectors. Direct Plant experience in a pharmaceutical setting with a minimum of 5 years preferred.
• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, team members and individuals.
• Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required.

Qualifications

• Knowledge and a comprehensive understanding of some 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).

Skills

• Experience working the requirements for third party external manufacturing.

Benefits

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

  Pay

  $141,500 - $268,500 USD

  Schedule

  Hybrid