Product Quality Strategy Leader Senior Director

Site Name: USA - Pennsylvania - Upper Providence, UK - London - Brentford
Posted Date: Feb 28 2024
The Product Quality Strategy Leader (PQSL) Senior Director is accountable for end-to-end Product Quality Strategy for products from pivotal or phase III including process/method validation, approval, launch, and post approval lifecycle management.
This role is accountable for product quality, compliance and continuous improvement during the product lifecycle as required based on risk, regulatory requirements, continuous process/method verification, commercial strategy and/or supply needs.
This role is accountable for ensuring robust supply chains are in place to enable product launch activities executed by the operations teams (sites and global functions) and ensure internal and cross-functional alignment with industry and regulatory expectations.
This role is the primary quality interface between functional partners (MSAT/R&D/Manufacturing Unit/Regulatory) and must ensure strong collaboration to deliver business goals and resolve complex issues related to product quality.
Key Responsibilities:

• Lead a team of Product Quality Strategy Leaders responsible for developing end-to-end product quality strategic plans with clear ownership for each deliverable and alignment with R&D, Manufacturing Science & Technology (MSAT), QC Analytical Leads, Regulatory Lead and Development/Manufacturing Strategy Leaders.
• Develop robust product quality strategy plan with clearly defined quality expectations for in licensed and outsourced products, ensuring compliance to global regulatory expectations and internal GSK QMS standards.
• Accountable for the product Quality overview of the product control strategy (CPP/CQA) and for the final approval of the product control strategy including the associated specifications, stability strategy and product shelf life.
• Partner with other quality functions to champion the critical quality management systems that will enable right first time launch and product robustness, e.g. change control, process validation, method validation and quality risk management.
• Role is accountable for product and analytical quality approval of file to Health Authorities and submission approval to Health Authorities for final registration documentation (CMC commercial for first filing) and major variations during lifecycle.
• Represent and interface with manufacturing and testing sites to champion a consistent approach to Quality and compliance standards across sites.
• Identify and assess quality risks (through continued process verification, continued method verification activities and annual product review) and proactively work with stakeholders to carry out mitigation and improvement plans to deliver robust supply chains.
• Ensure team of product quality strategy leads have plans in place to continuously develop the required competencies, drive standardisation, manage workload.
• Develop strategy for attracting and retaining key talent to ensure strong succession plans for product quality strategy lead roles.
• Serves as the global resource in the organization to provide product quality expertise, including audit and inspection preparation support (i.e. Product Quality related A&A audits).
• Proactively represent and promote GSK’s product quality interests externally.
  

Why You?
Basic Qualifications:

• Bachelors degree in Chemistry, Biology, Pharmacology, or related field.
• Ten or more years of experience in a quality function in a regulated field.
• Five or more years of experience working with CMC quality requirements.
  

Preferred Qualifications:

• MS or PhD in Biology, Chemistry, Pharmacology, or related field.
• Demonstrated leadership skills across functions and organisational levels.
• Deep knowledge of CMC and quality requirements, and Regulatory Authority Inspections
• Experience in strategy development and deployment
• Sound and timely decision-making and problem-solving skills in high impact situations
• Proven track record of leading teams successfully in a cross functional/ global setting
• Demonstrated knowledge of regulated environment with extensive knowledge of GMPs, and of quality and regulatory compliance requirements dealing with pharmaceutical manufacturing and quality assurance.
• Experience in strategy development and deployment, change/stakeholder management and business improvement.
• Strategic quality technical expert that can engage and define strategies across multiple functions including process development, analytical development.
• Proven experience working E2E having worked at the interface R&D/manufacturing and able to challenge R&D and CMC teams.
• Demonstrated leadership skills across functions and organizational levels.
• Strategic thinking and synthesis capacity with an ability to engage, influence and lead people from different areas of expertise, function and seniority.
• Able to ensure delivery of change programs involving stakeholders at all levels across different functions, regions and cultures in a highly regulated environment.
• Excellent knowledge of commercial registration processes and direct experience with Regulators (commercial submissions and/or inspections)
• Ability to solve complex issues in many fields and across many different cultures and regulatory environments.
• Strong people leader to engage and motivate a team of professionals.
• Understand Business Development activities from quality perspective.
• Ability to embrace change and drive transformation.
  

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why Us?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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