Associate Director, Technical Standards Lead

We are looking for an Associate Director, Technical Standards Lead to come join our newly created team of Technical Standards within the Rockville MSAT team. You will be accountable for setting up strategies and ensure GSK adheres with regards to areas such as Single Use Technology, Lifecycle Management and Cleaning Validation/ Contamination Controls and Single Use Technology/ Leachable & Extractable.

This is team will work in strong collaboration with the Technical Standard Team in gMSAT organization to define and implement site specific standards and procedures in accordance with global guidelines. The role will work in a matrix environment and will be participating in Community of Practice/ Task Forces in collaboration with global functions and will be overseeing a team of 2-3 direct report which will specialized in each of the areas of operations.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Coach and mentor the technical standards team (2-3 direct reports) with accountability in Lifecycle management, Cleaning Validation contamination control and Single Use Technology
• Maintain strong partnership with gMSAT Technical Standard team and stay current with best practices and guidelines
• Works cross-functionally and influence multiple stakeholders, refine and improve existing procedures
• Set strategic initiatives and roadmap for the team, including staying current to industry benchmark, new regulatory guidelines and best practices, procedures and establish new ways of working around the above-mentioned areas of responsibilities
• Main accountability at site level for responding to regulatory inspections and audit related queries to cleaning validation, contamination control
• Perform Risk Assessment for new materials
• Define guidelines and approach to improve strategies for cleaning validation, contamination control and lifecycle management in collaboration with external stakeholders (quality, engineering and gMST)
• Ensures implementation and define strategy around single use technology at the site, in partnership with procurement and supply chain

We are looking for professionals with these required skills to achieve our goals:

• Bachelors degree
• 10+ years of industrial experience in Biopharmaceutical process development, MSAT or CMC roles with emphasis on lifecycle approaches
• Experience with current trends in the industry, ICH Guidelines and GMP principles at commercial scale
• Prior experience with process validation and CPV, single use technology and E&L

If you have the following characteristics, it would be a plus:

• Demonstrated knowledge and understanding of PPQ strategy for DS biologics manufacturing processes, continuous process verification and overall validation strategy
• Strong interpersonal and leadership skills. Committed team player prepared to work in and embrace a team-based culture
• Able to interact well cross-functionally within the site and with multiple stakeholders out of the sites, in and out of GSC organization (GRA, global compliance etc.)
• Strong verbal and presentation communication skills which emphasize teamwork with a strong quality orientation
• Strong capability to prioritize effectively and deploy resources to ensure prompt resolutions to day-to-day issues

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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