Senior Manager, Product Quality Neurotoxin

Posted 8 Days Ago
Be an Early Applicant
Cork, IRL
Hybrid
Senior level
Healthtech • Pharmaceutical
The Role
Leads global product quality assurance for neurotoxin products and pipeline products, ensuring regulatory compliance, quality deliverables, complaint management, change control, CAPA, technical agreements, and inspection readiness. Partners with manufacturing sites, suppliers, regulatory affairs, R&D, supply chain, and commercial teams. Makes product quality and compliance decisions while supporting product transfers, launches, lifecycle management, and strategic quality initiatives.
Summary Generated by Built In
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 now recruiting a Senior Manager, Product Quality Neurotoxin for our diverse Team, This role will be a 24 month contract. 

Reporting to the Product Quality Director, you will be responsible for quality of assigned products and near commercial Neurotoxin Pipeline Products to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products under your remit include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. You will act as the primary quality representative for the global supply chain pertaining to manufacturing business relationships and build and maintain relationships with IME Operations, Supplier Quality Management, Commercial QA, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and S&T to ensure alignment on strategic initiatives.

Are you intrigued? Do you want to learn more? 
A snapshot of your key responsibilities would be:

  • Direct cross-functional team member to achieve on-time quality deliverables, high customer value, and high quality product to meet patient demands. Ensures delivery of quality elements needed to facilitate lifecycle management that provide products directly to distribution centers, or to AbbVie domestic and International plants for further packaging and/or testing.
  • Product Quality contact for Post Marketing Quality Assurance with end-to-end understanding and management of customer complaints across the various nodes within AbbVie.  Routine complaint trending and analysis.
  • Product Quality Assurance contact for Global Change control system, including Quality Assessment of changes, and oversight of all global changes.  Chair of the gCRB.
  • Develops Global Product Quality Assurance strategies and implements agreed strategies to support relevant products produced at AbbVie plants.
  • Reviews, approves and opens necessary Quality System Management records in a timely manner to maintain a high level of product compliance. Supports the management of exception documents and CAPA where relevant.
  • Makes key decisions on product quality, compliance and regulatory conformance issues and elevates medium and high-risk events to AbbVie management. 
  • Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the same agreements are being fulfilled.
  • Core team member or lead of strategic programs; including Brand Teams, New Product
  • Introductions, Product Transfers, Global Strategic Initiatives.
  • Influences the decision making process to ensure quality requirements are included when improvement initiatives take place.

 

Qualifications

Education & Experience  

  • Bachelor’s Degree in relevant Life Science or other Technical area required.
  • Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
  • Minimum of 5+ 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 pharmaceuticals.

 

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

Skills Required

  • Bachelor’s degree in a relevant life science or technical field
  • Technical or analytical background for resolving technical, quality, product, or engineering issues
  • At least 5 years of experience in quality assurance operations management, regulatory, operations, or technical support in a pharmaceutical setting
  • Regulatory inspection experience with direct interaction with regulatory inspectors
  • Knowledge and comprehensive understanding of biological and/or pharmaceutical products
  • At least 5 years of direct plant experience in a pharmaceutical setting

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support — Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
  • Parental & Family Support — Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
  • Leave & Time Off Breadth — Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.

AbbVie Insights

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The Company
HQ: North Chicago, IL
56,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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