QA - Validation Manager

Reposted Yesterday
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Hiring Remotely in Ancol Timur, Jakarta
Remote
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Lead Quality Assurance activities, oversee validation programs and audits, manage investigations to ensure compliance with regulations, and drive a culture of quality across the organization.
Summary Generated by Built In

GSK’s portfolio spans three product areas: vaccines, specialty and general medicines and our focus is to deliver better and faster for patients globally. Our unrivalled vaccine portfolio targets infectious diseases at every stage of life, helping to reduce the burden of disease for hundreds of millions of people. GSK has exceptional capabilities in vaccine science and technologies, including adjuvant/protein and mRNA. In specialty medicines, we are at the forefront of HIV prevention and treatment, and we are building our presence in key therapeutic areas such as oncology and immuno-inflammation. General medicines include our inhaled medicines for asthma and COPD, antibiotics and medicines for skin diseases.

By 2031, we aim to deliver more than £33 billion in annual sales – a step-change in performance and growth which will significantly increase the positive impact we can have on the health of billions of patients around the world. And we’re confident in our future. Our pipeline of 21 vaccines and 43 medicines includes many with potential to be first or best-in-class opportunities for patients

We are currently looking for an experienced QA - Validation Manager, with below responsibilities.

  • Lead Quality Assurance activities to ensure robust implementation of the Quality Management System (QMS), covering GMP/GDP compliance, data integrity, audit readiness, change control, deviation management, product complaints, and CAPA effectiveness.
  • Oversee validation programs for facilities, utilities, equipment, and manufacturing processes, ensuring compliance with regulatory requirements and GSK standards.
  • Conduct and oversee investigations (including Root Cause Analysis) for quality incidents, deviations, audit findings, and product complaints, ensuring timely resolution and prevention of recurrence.
  • Ensure Site’s Inspection Readiness, Support regulatory inspections and audits, ensuring readiness and effective communication with health authorities, including timely closure of commitments, and providing oversight on new and emerging regulations to maintain compliance.
  • Quality Culture, by implementing and maintaining the Quality Management System (QMS) to support consistent and compliance,
  • Partner cross-functionally with Production, Logistics & Warehouse, Engineering, EHS, Regulatory, Commercial Quality, and Customer Supply Chain teams to ensure seamless operations and end-to-end quality oversight.

Why you?

We look for people who appreciate the importance of safety and quality and strive to continuously improve our performance and practices.  We work in an open and transparent environment so you’ll be someone who treats others with respect and integrity – as you will be treated yourself. 

Ideally, we are looking for someone with:

- Bachelor’s degree in Pharmacy (Apothecary) with valid STRA as Responsible Pharmacist.
- Minimum of 8 years of experience in quality assurance or validation within the pharmaceutical or life sciences industry. Having managerial and project management experience would be an advantage.
- Strong knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

- Experience in managing validation activities for manufacturing processes and equipment.
- Proficiency in MS Office (Word, Excel, PowerPoint) and basic computer literacy.
- Strong communication, organizational, and problem-solving skills.

- Strong leadership in driving quality culture improvements: data integrity, audit readiness, investigations, CAPA, and continuous improvement.
Why Join Us?

Quality is at the heart of GSK’s purpose. We play an end-to-end role in developing, manufacturing, and distributing medicines and vaccines for patients. Our vision is Quality as a Competitive Advantage, achieved through:

  • Patient and Product Focus: Accelerating supply of high-quality medicines and vaccines.
  • Simplified & Standardised Systems: Driving Right-First-Time outcomes.
  • Proactive Quality: Using digital, data, and predictive analytics to partner with regulators.
  • Quality Starts with Me: Everyone at GSK owns quality

In this role, you will have the opportunity to:

  • Shape and strengthen the quality culture across all levels of the site.
  • Play a critical role in ensuring audit and inspection readiness and maintaining trust with regulators.
  • Work closely with cross-functional teams to continuously improve processes and systems, ensuring our products meet the highest standards of safety, efficacy, and quality.
  • Be part of a company culture that is ambitious for patients, accountable for impact, and guided by integrity and care.

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 [email protected]. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Top Skills

Excel
Gdp
Gmp
Ms Office (Word
Powerpoint)
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The Company
HQ: Brentford
105,615 Employees

What We Do

A science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.

We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people.

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