Job Description
Job Purpose
* Lead strategic continuous improvement initiatives (e.g. Lab Transformation) across Quality, including Quality Control, Quality Operations, and Quality Assurance.
* Work closely with the Global Quality Leadership Team and Site Quality leaders, and Digital Manufacturing partners to define and deploy transformation and continuous improvements strategies to deliver key business outcomes in alignment with our company priorities.
* Lead the Analytical Procedure Lifecycle (APLC) program in accordance with USP and ICH Q14.
* Partner with Analytical Research and Development (ARD), Large Molecule Analytical Sciences (LMAS), Analytical Chemistry in Development and Supply (ACDS), Digital Manufacturing and Site Quality to ensure that methods are developed, validated, and transferred to QC in alignment with APLC expectations.
* Oversee the Procedure Performance Verification of analytical methods in QC ensuring methods continue to perform in line with expectations to support reliable, compliant supply from Quality Control.
Key Accountabilities
* Collaborate with site quality leaders to understand their business challenges and create improvement plans to address gaps.
* Accountable to the Global Quality Leadership Team to ensure installation of foundational Manufacturing concepts aimed at delivering the most critical business outcomes.
* Coach and influence quality leaders in accordance with the operational excellence standards.
* Facilitate governance and report progress against strategic milestones defined in the continuous improvement plans.
* Oversee the development of monitoring and improvement plans for key products and gain approval for these plans via APLC Steering Committee. Monitor completion of plan actions and update APLC Steering Committee as appropriate.
* Work seamlessly with partners across site Quality Control internally as well as with external partners to ensure standardized and continuous Procedure Performance Verification (PPV).
* Accountable for global standardization of APLC activities for analytical methods, building strong strategic partnerships across the Manufacturing and Research and Development divisions.
* Support ARD in the implementation and execution of the enhanced APLC approach to method development, validation, and transfer for new and inline methods.
* Lead the overall scientific technical and operational efforts for APLC implementation for products.
Educational Requirements
* Bachelor’s degree or Master’s degree in a technical discipline (e.g. biochemistry, chemistry, microbiology) with at least 15 years of experience or a PhD with 10 years of experience in industry, working directly with technology transfer and QC.
* 10+ years of analytical testing or development experience with assay validation expertise.
* 5+ years of experience leading a team in a regulated environment.
Desired Skills And Experiences
* Experience with process improvements and application of Lean tools and techniques such as standardized work, scientific problem solving, value stream mapping, etc.
* Ability to recognize and mitigate barriers to cross-functional initiatives and act as an intermediary across divisional, geographical, and cultural boundaries.
* Ability to influence decision making, execute and coach on change management, and interact with all levels of the business (senior leaders to shop floor working teams).
* Strong emotional intelligence with a proven ability to build trust and develop new relationships to achieve successful outcomes at a local, regional, or global level.
* Experience enabling and leveraging diverse perspectives, experience, and talents to achieve business outcomes.
* Experience working in a GMP/regulated environment.
* Experience with Analytical Method Validation and relevant compendial guidelines, such as USP, ICH Q2/Q14, as well as analytical tech transfer.
* Expertise with late-stage regulatory submissions.
* Ability to manage multiple priorities and know when to escalate issues for resolution.
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