Associate Director, Aseptic Product Quality

AbbVie Inc.; Dublin; Hybrid; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

AbbVie Inc. in Dublin seeks an Associate Director to lead Aseptic Product Quality within the External & Product Quality Assurance Eye Care Global Team.

This role serves as the quality SME for aseptic manufacturing across external partners, driving continuous improvement and risk mitigation. Reporting to senior leadership, you will guide investigations, ensure regulatory compliance, and foster collaboration with AbbVie sites and TPMs/CMOs to uphold product quality and supply continuity.

Qualifikationen

• Bachelor’s degree in Life Science or technical discipline.
• 10+ years in Quality Assurance Operations, Regulatory, Operations, or Technical Support in pharma.
• Regulatory inspection experience with direct interaction with inspectors.
• Experience with third-party external manufacturing.

Aufgaben

• Lead the Aseptic External & Product Quality Assurance Eye Care Global Team and develop aseptic strategies.
• Conduct due diligence visits to prospective TPMs/CMOs as part of cross-functional teams.
• Perform hands-on assessments of aseptic manufacturing operations and drive best practices across external partners.
• Provide technical quality leadership for aseptic-related investigations and CAPA development.
• Monitor regulatory expectations and industry trends related to aseptic manufacturing and contamination control.

Kenntnisse

Leadership

Analytical thinking

Problem solving

Interpersonal skills

Regulatory awareness

Ausbildung

Bachelor’s degree in Life Science or technical discipline

Jobbeschreibung

Company Description

About AbbVie

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

We are currently looking for an Associate Director to join our team in Dublin, focused on Aseptic Product Quality. 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.

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.

Qualifications

• Bachelor’s degree in a relevant Life Science or other technical discipline required. 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+ years 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.
• 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 the knowledge and skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem-solving skills, positive interpersonal skills, the ability to manage multiple complex tasks simultaneously, and is capable of performing as a leader, team member and individual.
• Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required.
• A wide range of activities is 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 with the requirements for third-party external manufacturing.

Additional Information

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html