QA Validation Manager

We are seeking a QA Validation Manager to provide site-level quality oversight of validation and qualification activities across manufacturing processes, equipment, facilities, computerized systems, and analytical laboratories.

The role ensures compliance with company policies, cGMP and regulatory expectations by collaborating with Engineering, Tech Services, MSAT, Analytical Science and cross‑functional stakeholders to plan, execute and continuously improve validation delivery.

What you’ll do

• Lead and govern the site validation program: develop procedures, protocols and validation quality systems.

• Provide technical QA oversight for process/method validation, CSV and continued verification activities.

• Ensure TECH, MSAT, Analytical labs and Engineering GxP activities operate under robust quality systems.

• Drive validation KPIs, risk mitigation, investigations and CAPA effectiveness.

• Mentor and build capability across the site; plan resources and prioritise validation workload.

• Champion continuous improvement using GSK Production System, Tiers, Gemba and DMAIC principles.

Key responsibilities

Quality oversight — Validation & qualification

• Develop, maintain and govern effective validation procedures, templates and associated quality systems to manage all site validation activities.

• Support cross‑functional validation planning and provide QA oversight to ensure operational compliance using a science‑ and risk‑based approach (e.g., process validation, method validation, continued process verification, continued method verification).

• Generate, analyse and report metrics to monitor validation system performance and drive improvements.

• Maintain and share up‑to‑date knowledge of regulatory requirements and industry best practice related to validation.

• Establish and sustain validation training to build site capability and ensure personnel fulfil defined roles and responsibilities.

• Identify compliance risks linked to site facilities and systems and implement actions to mitigate risks to acceptable levels.

Quality oversight — TECH operations

• Ensure TECH (technical services) operates under an adequate quality system that complies with site policies and cGMP expectations.

• Provide QA input to TECH change control, investigations and CAPAs where these impact validated state.

• Quality oversight — MSAT Process Science & Analytical Science labs

• Ensure MSAT Process Science and Analytical Science laboratory operations have robust quality systems to meet cGMP expectations.

• Oversee method validation/verification, method transfers and laboratory data integrity as part of QA oversight.

Quality oversight — Engineering operations

• Ensure Engineering GxP activities (automation, facilities, utilities, pest control, maintenance) are governed by an adequate quality system consistent with site policies and cGMP.

• Provide QA oversight for qualification, commissioning and lifecycle management of engineering systems.

Interface with internal & external stakeholders

• Create and maintain effective interfaces with internal stakeholders and global teams (Global MSAT, Global Quality Assurance, StACE, etc.).

• Represent QA in cross‑functional forums to align site validation activities with network standards and expectations.

Management & planning

• Use capacity management to plan, prioritise and manage team workload.

• Define resource requirements, prepare resourcing plans and escalate resource or scheduling risks as needed.

Training & development

• Mentor, train and develop the QA validation team to ensure they can provide effective oversight and identify compliance risks across site validation activities and related functions.

• Monitor training effectiveness and close competency gaps.

Continuous improvement

• Provide guidance and support for continuous improvement activities (GPS: Tiers, Gemba, DMAIC, etc.) to increase validation efficiency, reduce rework and strengthen compliance.

Who we’re looking for

• Degree in science or engineering.

• ≥10 years in the pharmaceutical industry with at least 5 years hands‑on validation and 5 years leading validation activities/teams.

• Strong GMP, validation lifecycle and CSV knowledge.

• Proven ability to apply risk‑based, science‑led decision making.

• Excellent investigation, stakeholder influence and communication skills.

Preferred

• Formal quality/validation or Lean/Six Sigma training.

• Ability to apply risk-based validation and quality assurance standards to promote business edge

• Ability to facilitate business activities compatible with international regulatory environment

• Ability to solve complex / high impact investigation

• Experience in global network alignment and cross‑site governance.

• Track record of building site capability and delivering training programs.

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore    

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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

 

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

 

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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