The successful candidate will be responsible for the delivery of site Technical Standard for GSK Barnard Castle. The MSAT Technical Standards Lead leads a team of specialists at Barnard Castle, ensuring consistent application of global technical standards across legacy products and new product introductions. Key focus areas include Product Lifecycle Management (PLM), Cleaning Validation and Contamination Control, Visual Inspection, Single Use Systems (SUS), and Extractables & Leachables (E&L). The role provides technical leadership, promotes knowledge transfer through coaching, and oversees risk management and compliance for the site MSAT team. It also maintains an indirect reporting line to the MSAT Business Process, Standards, and External Manufacturing organisation.
In this role you will…
Leadership and Team Management:
- The MSAT Technical Standards Manager leads and manages the team of specialists, ensuring they have the necessary expertise and support to deliver technical excellence in Cleaning Validation, PLM, SuS and E&L, and Visual Inspection. The manager provides mentorship and fosters professional growth within the team, enabling the specialists to independently manage their respective technical standards while optimizing operational performance across the site.
Capability Building:
- The manager ensures that the team builds and maintains site capability in core MSAT standards by transferring knowledge and expertise across the site. This involves developing training programs, coaching the specialists, and ensuring readiness for implementation of technical standards. The manager actively works to enhance the team's skills and ensure alignment with global best practices.
Stakeholder Management:
- The manager plays a critical role in stakeholder management, working closely with Barnard Castle Senior Leadership Team (SLT), quality functions, and operations teams to ensure alignment and support for technical standards implementation. Additionally, the manager collaborates with above-site global MSAT teams to ensure seamless integration of global strategies into site-level practices. This involves negotiating priorities, influencing decision-making, and fostering strong relationships across functions to achieve organizational goals.
Governance and Oversight:
- The manager establishes governance frameworks to oversee the implementation of technical standards, ensuring that key performance indicators (KPIs) are in place to measure and drive continuous improvement. Additionally, the manager ensures effective risk management and compliance within the team, proactively identifying and escalating issues to prevent setbacks and ensure successful implementation of standards.
Alignment with Global Standards:
- The manager ensures that site-specific practices align with global MSAT standards, including tools, templates, and guidance. By collaborating with global MSAT Standards Leads, the manager supports the delivery of key GSC projects and initiatives, ensuring consistent implementation of technical standards across the site.
Regulatory Knowledge and Innovation:
- The manager maintains current knowledge of global regulations, inspection intelligence, and industry standards relevant to the technical areas managed by the specialists. This includes staying updated on innovative technologies and evaluating their applicability to enhance manufacturing capabilities. The manager ensures that the team remains compliant with regulatory requirements while driving innovation.
Why you?
Basic Qualifications & Skills:
- MSc in scientific discipline such as Scientific, Technical or Engineering with knowledge & experience on one or more of the following areas - validation life cycle for cleaning, product and process, contamination control, visual inspection or single use systems.
- Significant working experience required in relevant technical standard with proven application and delivery in one or more of the following areas: Cleaning Verification/Validation lifecycle, Process Validation Lifecycle (Stage 1- Stage 3), Contamination Control (PCCE, microbial), Visual Inspection, SUS
- Previous experience of working with multidisciplinary teams
- Strong technical writing and communication skills
Preferred Qualifications & Skills:
- PhD in scientific discipline
- Risk Management/ Project Management experience (qualification preferred e.g. Prince 2, PMP)
- Strategic thinking and planning.
- Ability to lead and motivate a team.
- Attention to detail and commitment to quality.
- Proficiency in digital tools and technologies.
- Innovative mindset and ability to drive change.
- Good knowledge of internal and external quality and EHS requirements
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