Takeda

Pharma

SeniorQualityComplianceSpecialist

S$95–145k ~AI est. Woodlands, Singapore FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Senior Quality Compliance Specialist at Takeda. Skills: Quality compliance, Regulatory submissions, GMP. Ensure compliance with GMP. Develop and implement quality control procedures”

What You'll Achieve.

Maintain high quality standards; Ensure regulatory compliance; Support successful product launches

Industry & Context.

Pharma
Problems you'll solve

Root cause analysis; Corrective actions

What They're Looking For.

Must Have

Bachelor's degree in a relevant field, 5+ years of experience in quality assurance or compliance, Experience with GMP, Experience with regulatory submissions

Nice to Have

Master's degree preferred, Experience with data analysis tools, Experience with quality management systems

What You'll Do.

Ensure compliance with GMP

Develop and implement quality control procedures

Conduct internal audits

Manage external audits

Prepare and review regulatory submissions

Investigate deviations and implement corrective actions

Monitor quality metrics

Collaborate with cross-functional teams

How You'll Work.

Team & Collaboration

Cross-functional teams; Regulatory agencies

Communication Scope

Report writing; Presentation skills

Full Job Description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s [Privacy Notice](https://jobs.takeda.com/privacynotice) and [Terms of Use](https://www.takeda.com/terms-and-conditions/). I further attest that all information I submit in my employment application is true to the best of my knowledge. ## **Job Description** **Company Profile:** Takeda's Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the company’s Biologics Operating Unit network, the site is Takeda’s only biologics drug substance manufacturing facility in Asia. The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda’s first positive energy building certified by Singapore’s Building and Construction Authority’s Green Mark scheme in 2022. **Job Title: Senior Quality Compliance Specialist Location: Woodlands, Singapore** **About the role:** * This position is responsible for site quality compliance governance and product quality and compliance communications to achieve the site objectives for Takeda Singapore. **How you will contribute:** _Inspection and Audit Management_ * Support to host and manage regulatory inspection and communications. * Support and ensure the site is inspection ready at all times. * Lead and support the site inspection readiness activities. * Lead Auditor to lead the self inspection program and plan for self inspection schedule. * To perform supplier qualification which include supplier audit. _Site Quality Compliance Governance_ * Participate and lead Quality System(s) rollout by ensuring that the elements of the assigned Quality System (s) is / are implemented and maintained at the site according to regulatory, corporate and division requirement for Quality Coun

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