Senior Manager, Lab Systems and Operations
Company: AbbVie
Location: Worcester
Posted on: July 12, 2025
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Job Description:
Company Description 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 immunology, oncology, neuroscience, and eye care
and products and services in our Allergan Aesthetics portfolio. For
more information about AbbVie, please visit us at www.abbvie.com .
Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and
Tik Tok . Job Description Purpose The Global Project Lead is a
pivotal and influential role within our organization, responsible
for shaping and supporting the clinical pipeline with a strategic
focus on the analytical testing domain. This role is paramount in
providing comprehensive governance over the method lifecycle,
ensuring that analytical methods and processes are robust, fit for
purpose, and effectively aligned with our global commercial
strategies and Quality Control Laboratories' standards.
Responsibilities Governance and Oversight: Relevant analytical Lab
experience in Biologics Testing Lead the governance framework to
ensure future commercial methods are globally fit for purpose,
robust, and optimized for full-scale manufacture, influencing
quality on a global scale. Oversee the development and validation
of analytical methods for new product introductions (NPIs),
ensuring they meet global standards. Provide high-level technical
support throughout the method lifecycle, guaranteeing alignment
with our strategic goals and quality expectations. Maintain an
up-to-date and in-depth understanding of global regulatory
requirements influencing product testing and development, ensuring
compliance and proactive strategy adaptation. Method Development
and Transfers: Deliver quality oversight across the lifecycle of
methods, ensuring they comply with global regulatory standards and
align with organizational business objectives. Manage and oversee
seamless method transfer processes to and between Biologics sites
worldwide, ensuring integration, continuity, and quality
consistency. Data Integrity: Ensure the integrity and accuracy of
raw data used in validation processes and Test Method Transfers
(TMTs) within our global network of Quality Control Laboratories.
Implement and uphold best practices for data management and
integrity, fostering a culture of precision and accountability
organization-wide. Cross-Functional Collaboration: Collaborate
proactively with global R&D, Quality Assurance, and PDS&T
teams to align project goals and timelines on a global scale.
Facilitate effective and open communication between global
departments to ensure timely achievement of project milestones and
support organizational excellence. Qualifications Bachelors Degree
in relevant Life Science, Engineering, 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 8 years. At least 3 years in Quality Assurance Operations
Management; 5 years in any of the following areas; Operations,
Research and Development, Regulatory or Consulting. Direct
Manufacturing Plant experience in a Pharmaceutical setting is
preferred. Knowledge and a comprehensive understanding/expertise 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). Strong quality assurance/control,
manufacturing, laboratory, technical support, regulatory, and/or
validation background is required. Experience with FDA and other
regulatory agency interactions and inspections is required.
Familiarity with the requirements for third party external
manufacturing. 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, members and
individuals. Key Stakeholders External Manufacturing Business
Relationships, Operations, Third Party Manufacturers Business
Alliance, Commercial, Global Supply Chain, Domestic and
International AbbVie Plants and Affiliates, Regulatory Affairs,
Research and Development. 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
Keywords: AbbVie, Plymouth , Senior Manager, Lab Systems and Operations, Manufacturing , Worcester, Massachusetts
