Quality Assurance Specialist

Posted 14 Days Ago
Be an Early Applicant
Hiring Remotely in Selangor, MYS
Remote
Entry level
Biotech • Pharmaceutical
The Role
Maintain pharmaceutical and medical-device quality systems and compliance with GMP, GDP, and regulatory requirements. Oversee product release, quality indicators, inspections, complaints, deviations, recalls, CAPA, third-party manufacturing and distribution activities. Support medical-device licensing, safety actions, regulatory reporting, and data-integrity initiatives while partnering with supply chain, regulatory affairs, suppliers, and authorities.
Summary Generated by Built In

Job Description Summary

#LI-Onsite
Location: Selangor, Malaysia
Relocation Support: This role is based in Selangor, Malaysia. Novartis is unable to offer relocation support: please only apply if accessible.
Make quality count where it matters most: protecting patients and ensuring trusted medicines reach them safely. As a Quality Assurance Specialist, you will strengthen quality and compliance across pharmaceutical products and medical devices, collaborating with internal teams, external partners, and regulatory authorities. You will help maintain robust quality systems, support inspection readiness, oversee product-release activities, and promote a strong culture of data integrity and continuous improvement across the organization.


 

Job Description

Deadline for applications: 28th October 2026.


Major Accountabilities:

  • Maintain quality systems and procedures supporting Good Manufacturing Practice and Good Distribution Practice compliance.
  • Oversee product release against registered specifications and applicable regulatory requirements.
  • Monitor key quality indicators, identify gaps, and coordinate timely risk-mitigation actions.
  • Manage inspections, complaints, deviations, recalls, product tampering, and corrective and preventive actions.
  • Provide quality oversight for third-party manufacturing, packaging, labelling, storage, and distribution activities.
  • Support medical-device compliance, licensing, safety actions, complaint handling, and regulatory reporting.
  • Promote data-integrity awareness and coordinate plans that strengthen a culture of responsible data management.
  • Partner with supply chain, regulatory affairs, external suppliers, and regulatory authorities on quality matters.

Essential Requirements:

  • Degree in life sciences or a related field.
  • Experience in quality assurance or quality control within the pharmaceutical or healthcare industry.
  • Knowledge of Good Manufacturing Practice and Good Distribution Practice requirements.
  • Understanding of local pharmaceutical regulations, quality standards, and applicable medical-device requirements.
  • Fluency in written and spoken English and the local language.
  • Strong communication, collaboration, and stakeholder-management skills across cross-functional and external partnerships.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.


Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture


Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network


Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards


 

Skills Desired

Skills Required

  • Degree in life sciences or a related field
  • Experience in quality assurance or quality control within the pharmaceutical or healthcare industry
  • Knowledge of Good Manufacturing Practice requirements
  • Knowledge of Good Distribution Practice requirements
  • Understanding of local pharmaceutical regulations and quality standards
  • Understanding of applicable medical-device requirements
  • Fluency in written and spoken English and the local language
  • Strong communication, collaboration, and stakeholder-management skills

Novartis Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.

  • Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
  • Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
  • Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.

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The Company
HQ: Basel
110,000 Employees
Year Founded: 1996

What We Do

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

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