Regional QA Engineer, Integrated Solutions

GLOBAL LIFE SCIENCES SOLUTIONS SINGAPORE PTE. LTD.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive benefits

Health care program

Paid time off

Job summary

Cytiva in Singapore is seeking a Regional QA Engineer for APAC to drive QA and compliance across the Integrated Solutions business. You will act as the QA representative on customer sites and support QMS activities, audits, and continuous improvement initiatives.

The role requires a Bachelor-level engineering degree, 5+ years in quality roles in life sciences, and strong knowledge of ISO 9001 and cGMP. Travel up to 50% nationwide/internationally is expected.

Qualifications

• Bachelor's degree in engineering (BEng or BSc) required.
• 5+ years in quality roles within life sciences.
• Strong knowledge of ISO 9001 and cGMP.

Responsibilities

• Lead QA and compliance activities for APAC IS projects.
• Manage QMS processes including NC, CAPA, audits.
• Coordinate project QA governance and continuous improvement initiatives.
• Provide training and support for quality associates and teams.

Skills

Quality management

Project leadership

Cross-functional collaboration

English + another language

Education

BEng or BSc

Tools

ISO 9001

cGMP

Job description

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

Together with colleagues in the region, the Regional QA Engineer, Integrated Solutions APAC, is part of the global QA team that is supporting the Custom Engineering and Integrated Solutions businesses world-wide. This person works as the QA representative for IS projects and project execution at customer sites, supports the effectiveness of the QMS, and liaises with stakeholders in the organization to drive continuous improvement.

This position reports to the QA Director - Custom Engineering & Integrated Solutions and is located in Singapore and will be an on-site role.

What you will do:

• Responsible for driving QA and compliance activities for the Integrated Solutions business in APAC, including but not limited to: Milestone approvals of projects, ensure resources for onsite QA support, act as onsite QA being the customer facing representative from QA
• Manage QMS processes like NC, CAPA, Complaints, document review and support internal/external audits
• Lead and manage validation QA strategy, project QA governance & processes, CIP (Continuous Improvement Project) & LL (Lesson Learnt Initiatives) for IS Business
• Support project performance reviews and develop input to Quality management reviews
• Supports development of training material and delivers training of quality associates and internal teams

Who you are:

• Essential Qualifications/Education: BEng or BSc
• Minimum 5 years of experience in Quality role, preferably in the Life Sciences industry
• Comprehensive understanding of ISO 9001 & cGMP requirements
• Experienced in managing project teams and working cross functionally, both locally & globally.
• Ability to communicate effective in English plus one other language (for example: Chinese, Korean, Japanese) written and spoken.
• Travel, Motor Vehicle Record & Physical/Environment Requirements:
• Ability to travel globally and at short notice up to 50%
• Must have a valid driver's license

It would be a plus if you also possess previous experience in:

• 5 to 10 years of proven experience as a quality assurance professional in a GMP environment
• Managing teams and direct reports across multiple locations

Benefits

• Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.