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 DescriptionPurpose
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- Bachelor's 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 InformationAbbVie 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
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https://www.abbvie.com/join-us/reasonable-accommodations.html
