Aseptic Product Quality Associate Director

AbbVie•Worcester, MA

19h•$141,500 - $268,500

About The Position

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.The Associate Director is responsible for performing aseptic assessments, supporting aseptic-related investigations, and advancing the implementation of best practices across the external manufacturing network. The role also evaluates aseptic standards across internal and external operations, while maintaining awareness of evolving technologies and industry practices .In close partnership with TPMs/CMOs and internal stakeholders, this position drives continuous improvement through the proactive identification, assessment, prioritization, and mitigation of aseptic risk. The role also fosters strong collaboration across AbbVie manufacturing sites, global aseptic teams, and cross-functional partners to strengthen quality oversight and ensure alignment across the network.

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.
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.
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).
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.
A wide range of activities are undertaken from long term strategy development to short term crisis management. The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives to effectively manage the action plans that will resolve the issues.
Experience working the requirements for third party external manufacturing.

Nice To Haves

Direct Plant experience in a pharmaceutical setting with a minimum of 5 years preferred.
Graduate degree desired.

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