Job Description

At GSK Singapore in our Jurong API plant, our Quality team is dedicated to ensuring excellence across manufacturing and compliance. The team spans key areas, including Quality Systems & Data, Compliance, Audit & Regulatory, Quality Technical & Validation, Operation Quality, and QC functions. Together, we drive innovation, uphold regulatory standards, and deliver high-quality APIs, fostering a culture of continuous improvement and collaboration.
Purpose
This role is an exciting opportunity to lead and manage quality systems and data processes at Jurong API Plant.The ideal candidate will bring a strong blend of technical expertise, strategic thinking, and interpersonal skills to ensure compliance with regulatory standards and drive continuous improvement initiatives. With a focus on process and system optimization, they will support the delivery of high-quality APIs while leveraging their planning and organizational abilities to manage change effectively.
Collaboration is central to this position, requiring teamwork and stakeholder engagement to align priorities and enhance quality systems. Analytical and logical thinking will be key to identifying risks and implementing robust risk management strategies. The candidate will also demonstrate exceptional influencing skills to drive consensus and support for quality initiatives.
We value candidates who are detail-oriented, proactive, and passionate about quality and data management. Their ability to balance multiple priorities with strong organizational skills will ensure the successful delivery of projects and compliance standards. This role is ideal for someone who thrives in a dynamic environment, is solution-oriented, and is committed to fostering a culture of excellence and compliance.
Responsibilities:

• Define, maintain, and implement quality compliance standards for the Jurong API manufacturing site.
• Ensure adherence to internal (GSK corporate) and external requirements (ICH, FDA, EMEA, PMDA etc.) on current Good Manufacturing Practices (cGMP) and Data Integrity (DI).
• Oversee product manufacturing and supply compliance with QMS requirements.
• Set up and manage the site Quality Improvement Plan (QIP) and Data Integrity Plan (DIP).
• Lead and support key quality initiatives; collaborate with cross-functional teams to identify and implement process improvements.
• Manage strategic QMS projects from central Quality for site deployment.
• Deliver quality process / system simplification and improvement initiatives within quality functions; enhance data management practices and ensure alignment with global standards
• Enhance organizational performance by managing the site training framework aligned with global standards, systems, and processes.
• Support audits and inspections, acting as a subject matter expert for quality systems and data.
• Provide governance, drive trend monitoring and review, propose continuous improvement actions via e.g. Site Quality Council meetings

Requirement:

• Bachelor's degree in science, engineering, or a related field
• Experience in pharmaceutical or healthcare industries.
• At least 8 years of experience in quality systems, validation, audit or data management within a regulated industry.
• Familiarity with validation processes for equipment, systems, and processes.
• Knowledge of data integrity principles and practices.
• Experience in audits and regulatory inspections.
• Ability to work effectively in a cross-functional, matrix environment.
• Strong knowledge of Good Manufacturing Practices (GMP)
• Excellent organizational and problem-solving skills.
• Proficient in data management tools and systems.
• Strong communication skills, both written and verbal.

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*Work Arrangement:
This role is based on-site in Singapore, with flexibility for hybrid working arrangements as needed.
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.
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Skills Required