Senior Manager Aseptic Product Quality

AbbVie; Leinster; On-site; EUR 120,000 - 180,000; Full time

Job summary

AbbVie seeks an Associate Director for Aseptic External & Product Quality Assurance Eye Care Global Team to lead aseptic strategies and ensure robust product quality across external manufacturing networks. The role collaborates with TPMs/CMOs and internal stakeholders to strengthen quality systems and drive continuous improvement.

The ideal candidate has 10+ years in pharma QA operations, deep regulatory inspection experience, and a track record of resolving aseptic quality issues while

Qualifications

• Bachelor’s degree in Life Science or technical field; graduate degree preferred.
• Minimum 10+ years in Quality Assurance Operations Management, Regulatory, Operations or Technical Support in pharma.
• Experience with regulatory inspections and direct interaction with inspectors.
• Plant-level experience in pharmaceutical manufacturing with 5+ years preferred.
• Knowledge of sterile, biologic, and other pharmaceutical technologies.

Responsibilities

• Lead aseptic external quality team and implement aseptic strategies across external partners.
• Perform due diligence visits to TPMs/CMOs and assess aseptic manufacturing operations.
• Provide technical quality leadership for aseptic-related investigations and CAPAs.
• Monitor emerging technologies, regulatory expectations, and industry trends.
• Provide quality oversight to ensure compliance with regulatory requirements and quality standards.
• Support risk-based decision-making for aseptic manufacturing and external quality operations.

Skills

Leadership

Quality assurance

Regulatory

Investigations

Cross-functional

External manufacturing

Education

Bachelor's Life Science

Graduate degree desired

Job 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.

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

• 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.
• 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.

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

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.

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