Senior Manager, Lab Systems and Operations

ZipRecruiter; Worcester; On-site; GBP 70,000 - 100,000; Full time

Job summary

AbbVie is seeking a Global Project Lead responsible for shaping clinical pipelines with a focus on analytical testing. This pivotal role requires oversight of analytical methods, ensuring compliance with global standards, and fostering collaboration across departments. Candidates should possess a strong background in life sciences and extensive experience in quality assurance and operations in the pharmaceutical sector.

Qualifications

• 8+ years of experience in relevant fields.
• Strong background in QA/QC and regulatory inspections.
• Experience in pharmaceutical manufacturing preferred.

Responsibilities

• Lead governance framework for analytical methods globally.
• Oversee method development and validation for new products.
• Ensure data integrity and best practices in QC labs.

Skills

Analytical Skills

Interpersonal Skills

Leadership

Multitasking

Data Management

Education

Bachelor’s Degree in Life Science, Engineering, or related field

Job description

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 TikTok.

Job Description

Purpose

The Global Project Lead is a pivotal role within our organization, responsible for shaping and supporting the clinical pipeline with a focus on analytical testing. This role provides governance over the method lifecycle, ensuring analytical methods are robust, fit for purpose, and aligned with global commercial strategies and Quality Control 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 manufacturing, influencing quality globally.
• Oversee development and validation of analytical methods for new product introductions, ensuring compliance with global standards.
• Provide technical support throughout the method lifecycle, aligning with strategic and quality goals.
• Maintain understanding of global regulatory requirements affecting product testing and development, ensuring compliance and proactive strategy adaptation.

Method Development and Transfers:

• Deliver oversight across the method lifecycle, ensuring compliance with regulatory standards and organizational objectives.
• Manage seamless method transfer processes across worldwide biologics sites, ensuring quality and continuity.

Data Integrity:

• Ensure integrity and accuracy of raw data in validation and transfer processes within our global QC labs.
• Implement best practices for data management and integrity, fostering a culture of precision and accountability.

Cross-Functional Collaboration:

• Collaborate with R&D, Quality Assurance, and PDS&T teams to align project goals globally.
• Facilitate effective communication across departments to meet project milestones and organizational standards.

Qualifications

• Bachelor’s Degree in Life Science, Engineering, or related field. Technical or analytical background required.
• Minimum 8+ years of experience, including at least 3 years in Quality Assurance Operations Management and 5+ years in operations, R&D, regulatory, or consulting. Direct manufacturing experience in pharma is preferred.
• Knowledge of biological/pharmaceutical technologies (e.g., sterile, biological, solid dosage forms, etc.).
• Strong QA/QC, manufacturing, lab, regulatory, and validation experience.
• Experience with FDA and other regulatory inspections.
• Familiarity with third-party manufacturing requirements.
• High urgency environment, analytical skills, interpersonal skills, multitasking ability, leadership qualities.

Key Stakeholders

External manufacturing, operations, third-party manufacturers, commercial, supply chain, global plants and affiliates, regulatory, R&D.

Additional Information

AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. For more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. Applicants seeking accommodations can find more information at https://www.abbvie.com/join-us/reasonable-accommodations.html.