Sterility Assurance QA Director
* Requisition ID: WD155763
* Position: Full-Time Regular
* Open date: Feb 8, 2018 11:07 AM
* Functional area: Quality
* Required degrees: Not Indicated
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The main purpose of the job is the management of a team of global experts covering the different domains of sterility assurance with the purpose of developing standards and processes, continuous improvement plans, trouble shooting and knowledge management. Management of senior experts requires specific leadership skills to create an engaged and inclusive working environment sustainable over time.
Beyond the typical people management duties (recruitment, development and retention of highly skilled technical talents), it is critical to promote the coordination of global network of technical expertise (expert communities) in the different domains. To create competitive advantage implementing right industry standards and expectations from regulatory agencies, it is essential to promote internal and external benchmarking.
Knowledge management dimension of the job purpose is critical because sterility assurance is highly people dependent and the need to increase and maintain sterility assurance capabilities in GSK Vaccines is a key success factor. Development of knowledge management processes (skill assessments across the organization, training, coaching, mentoring, etc.) and implementation in R&D and mainly in GIO/Q are key elements of the purpose of the job.
Project management is also a key part of the job to drive transversal projects related to sterility assurance within the network to embed and grow sterility assurance standards and mindset throughout the organization.
The job scope encompasses R&D, all GSK vaccines sites and key supporting functions such as MS&T and Engineering).
Your responsibilities are:
* Recruitment, development and retention of highly skilled technical talents in the domains of sterility assurance. Develop the group as a reference center for Vaccines in sterility assurance domains and be recognized as the best global experts for GSK and beyond.
* Partnership with Sterility Assurance Business Partners to manage internal priorities based on YOP, capacity management tools and local requirements (trouble shooting) to ensure proper equilibrium between preventive versus corrective initiatives.
* Promote collaboration between experts for the different domains of expertise to ensure appropriate objective setting, prioritization, consistency of approach, issue resolution and back-up solutions within the team.
* Ensure through global experts that community of practices is active across the organization (R&D, GIO/Q, and supporting functions) for major sterility assurance domains.
* Promote internal and external benchmarking to build competitive advantage by implementing the right industry standards and expectations from regulatory bodies. Approve Vaccine Quality Guidance developed by global experts to incorporate the right expectations into Vaccines quality standards.
* Set mid/long term vision and strategy for respective domain of expertise covering sterility assurance.
* Partnership with Vaccine Learning Center and GIO sites to develop practical knowledge management processes to increase and maintain sterility assurance capabilities in the organization.
* Through Global Sterility Assurance Experts, develop training packages and coaching/mentoring tolls for education purpose for manufacturing sites/MPUs and other stakeholders such as engineering, MS&T and R&D.
* Develop competency grid assessments and propose customized learning solutions to fill identified competency gaps (capability and capacity) in sterility assurance domains.
* Identify and drive transversal projects related to sterility assurance throughout the organization
Why You?Basic qualifications:
Master degree with a minimum of 15 years' experience in manufacturing (operation, QA, validation) or R&D environment
* Ph.D., MS, Bio-engineer, Pharmacist
* Minimum 15 years' experience in aseptic or bioburden control manufacturing environment (production, QA, validation) with demonstrated successful results, preferably in FDA regulated environment. Knowledge management experience and people management are key factors.
GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Sterility Assurance Center of Excellence (StACE) belonging to Quality Shared Share Services has three missions: Definition of standard Continuous improvement and Knowledge management. It is a global team covering all Global Industrial Operations and R&D for sterility assurance related topics.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
If you require a reasonable adjustment to the application/selection process to enable you to demonstrate your ability to perform the job requirements you will have the opportunity to let us know what specific assistance you require. This will help us to make suitable arrangements to support you throughout our selection process.