Product Quality Strategy Leader

GSK; Barnard Castle; Vor Ort; GBP 140.000 - 180.000; Vollzeit

Zusammenfassung

GSK is seeking a Product Quality Strategy Director to lead end-to-end product quality strategy from pivotal readiness through launch and lifecycle management. You will ensure Quality, regulatory readiness, patient impact, and supply continuity across CMC, QA, R&D, and manufacturing in a complex enterprise matrix.

This role provides global leadership, representing Quality at PSLT and senior governance forums, and guiding risk-based recommendations, regulatory submissions, and post‑approval

Qualifikationen

• Bachelor’s degree required; 10+ years in pharma Quality/Technical functions
• Experience in GMP and regulatory readiness
• Experience with product lifecycle management and risk management
• Experience with regulatory submissions and inspection readiness
• Matrix leadership and governance participation experience
• Enterprise leadership aligning quality decisions with patient impact and business goals
• Demonstrated ability to influence without direct authority
• Strong understanding of GMP and global regulatory expectations

Aufgaben

• Develop, integrate, and govern end-to-end Product Quality Strategy from pivotal readiness through launch and lifecycle management
• Lead the Product Quality Team and coordinate with QA, R&D, MSAT, Manufacturing, and supply functions
• Represent Quality at PSLT, CMC, and senior governance forums with risk-based recommendations
• Provide quality leadership for pivotal filings, inspections, and post-approval readiness
• Oversee Quality elements within CMC matrix teams and milestone-readiness activities
• Drive proactive risk detection, escalation, mitigation, and governance
• Coordinate matrix oversight of QMS and lifecycle processes (CAPAs, deviations, changes, etc.)
• Improve PQS processes, standards, and organizational capability

Kenntnisse

GMP experience

Product lifecycle

Regulatory submissions

Matrix leadership

Quality risk mgmt

New product introduction

Inspection readiness

Governance participation

Ausbildung

Bachelor’s degree

Master’s degree

Jobbeschreibung

The Product Quality Strategy Director is accountable for setting, integrating, and governing end-to-end Product Quality Strategy for business-critical assets from Commit to Pivotal Readiness through initial commercial launch in major markets and critical lifecycle change activities. The role serves as the independent Quality representative and One Quality Voice across CMC, Quality, R&D, MSAT, Manufacturing, Regulatory Affairs, Site Quality, QC, supply functions, and strategic partners. Through enterprise matrix leadership, the role ensures product quality, patient impact, regulatory and inspection readiness, supply continuity, and product quality risk management are embedded in development, registration, launch, commercialization, and lifecycle decisions. Oversight continues where post‑approval supply‑chain changes, acquisitions, alliance products, or strategically critical portfolios require sustained senior quality leadership outside manufacturing‑site operational ownership.

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

• Develop, maintain, and integrate end-to-end Product Quality Strategy for assigned assets from pivotal readiness through launch and lifecycle management, ensuring Quality, Technical Development, Product Quality Risk, Compliance, Regulatory, patient, and supply considerations are embedded in asset strategy and governance decisions.
• Lead the Product Quality Team and influence GSC Technical, GSC Product Strategy, GRA CMC, R&D CMC, Quality, R&D, MSAT, Manufacturing, Site Quality, QC, supply functions, and strategic partners to align priorities, decisions, readiness plans, and accountable delivery.
• Represent Quality as the One Quality Voice at PSLT, CMC, product, and other senior governance forums, providing objective risk‑based recommendations, resolving quality‑position differences, and escalating unresolved issues through appropriate governance routes.
• Provide Quality leadership for pivotal, filing, launch, inspection, and post‑approval readiness, including strategic input to control strategy, comparability strategy, regulatory submissions, health‑authority responses, PAI preparation, and critical quality controls, as applicable.
• Be accountable for Product Quality elements within CMC matrix teams and for Quality review, approval, and execution oversight of Product Quality deliverables and milestone‑readiness activities, as required.
• Drive proactive product quality risk detection, assessment, governance, escalation, mitigation, and acceptance, ensuring clear accountable owners, effective action plans, documented rationale, and timely senior‑governance visibility.
• Coordinate matrix oversight of relevant QMS and lifecycle processes for assigned assets, including changes, deviations, CAPAs, complaints, product quality reviews, validation, post‑approval changes, dossiers, regulatory submissions, and associated controls.
• Drive end‑to‑end Product Quality for commercial Vaccines or Medicines as a competitive advantage through proactive product, process, analytical, digital, and knowledge‑management improvements that strengthen patient outcomes, compliance, supply continuity, and business performance.
• Serve as global subject matter expert for new product introduction and product quality lifecycle change management and, as applicable, Major Change Control Reviewer, PIRC member, and Quality point of contact for Alliance and Strategic Partners.
• Improve Product Quality Strategy processes, standards, governance frameworks, and organizational capability through lessons learned, coaching, knowledge sharing, reusable tools, and continuous improvement.
• Translate complex technical, quality, compliance, regulatory, patient, and supply risks into clear business recommendations and governance decisions.
• Monitor product quality signals, complaint trends, deviations, CAPAs, product quality reviews, stability, and lifecycle information to identify emerging risks and required action.
• Drive timely communication, escalation, decision documentation, ownership, and follow‑through for quality, compliance, regulatory, and supply risks.
• Coach and develop colleagues through technical guidance, decision support, knowledge sharing, and contribution to the PQSL community of practice

Basic Qualification

• Bachelor’s degree
• Minimum 10 years of pharmaceutical‑industry experience across Quality and/or Technical functions
• Experience in GMP
• Experience with product lifecycle management
• Experience with product quality risk management and new product introduction
• Experience with regulatory submissions and inspection readiness
• Matrix leadership experience
• Governance participation experience

Preferred Qualification

• Master’s degree.
• Experience in more than one Quality or Technical role is preferred.
• Deep understanding of GMP, pharmaceutical quality systems, Quality Assurance and/or Quality Control, product lifecycle management, and global regulatory expectations.
• Demonstrated enterprise leadership capability connecting quality decisions to patient impact, product strategy, supply continuity, regulatory outcomes, and business priorities.
• Proven matrix leadership and stakeholder‑influence skills, including resolving conflict, creating One Quality Voice, and driving delivery without direct line authority.
• Strong product quality risk‑management capability, scientific judgment, systems thinking, and ability to make or recommend decisions under uncertainty and ambiguity.
• Deep understanding of GMP, pharmaceutical quality systems, Quality Assurance and/or Quality Control, product lifecycle management, and global regulatory expectations.
• Demonstrated enterprise leadership capability connecting quality decisions to patient impact, product strategy, supply continuity, regulatory outcomes, and business priorities.
• Proven matrix leadership and stakeholder‑influence skills, including resolving conflict, creating One Quality Voice, and driving delivery without direct line authority.
• Strong product quality risk‑management capability, scientific judgment, systems thinking, and ability to make or recommend decisions under uncertainty and ambiguity.

Skills

Assurance Framework, Data Integrity, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Quality Strategy, Risk Awareness, Technical Writing

Italian Salary Range / Fascia retributiva in Italia: EUR 83,250 to EUR 138,750Belgium Salary Range / Fourchette salariale – Belgique: EUR 115,500 to EUR 192,500The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

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

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