Illumina Singapore Pte Ltd

Manager, QMS & Compliance Quality

Illumina Singapore Pte Ltd Date Posted: 11-Oct-2017

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Job Description

Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. Life at Illumina is about working with teammates who are deeply passionate about what we do, because we know that our work has the power to improve lives. We’re an established company with a track record of phenomenal growth. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.

Basic Function and Scope of the Position:


Responsible for the management of the IIlumina's Quality Compliance program via auditing and CAPA management.




Tasks and Responsibilities:

  • Implement and monitor effectiveness of the quality management system (OMS) strategies, initiatives and objectives established by management.
  • Monitor and apprise management of changes to quality system regulations and requirements. This include staying current on applicable FDA, ISO (including risk management), and other applicable industry requirements applicable to lllumina.
  • Schedule, coordinate, and prepare the Quality Management Review (QMR) presentation, providing the current state of the OMS including post market product review information.
  • Regularly communicate the status of the internal audit program, audit nonconformance reports, NCR actions, documents requiring review/update and CAPA's to management.
  • Implement new and revised processes and documents to continually improve the OMS.
  • Identify, collect, analyze and compare key quality system performance data against established acceptance criteria.
  • Direct and/or conduct investigations into potential quality/compliance concerns. Ensure that root causes of quality system problems are identified and that appropriate preventive I corrective actions are taken. Keep management informed of issues.
  • Manage the Quality Management System (OMS), Internal Audits, and Management Review.
  • Effectively manage the internal audit program through the preparation of the audit schedule, ensuring auditors are qualified, ensuring audits are conducted on time and internal audit NC's are completed on time.
  • Provide GMP and Quality Management System training to the applicable departments.
  • Provide support to the management representative during FDA inspections and external quality audits.
  • Provide support to the Product Evaluation function through entering and closing customer complaints, performing product evaluations, generating reports, and other responsibilities as requested.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.


Preferred Educational Background:

  • University Degree in a scientific discipline or equivalent.
  • Master's and/or PhD preferred.

Preferred Experiential Background:

  • 10+ years related manufacturing environment experience required; preferably GxP
  • > 5 years' experience in project management, configuration management, and/or quality departments within a regulated environment, preferred
  • Good understanding and knowledgeable of FDA regulatory environment (CFR 820), 501k and ISO 13485, CMDR strongly preferred.
  • Experience with process and material change and configuration activities within an Enterprise Resource Planning (ERP) system, SAP desirable
  • Product Lifecycle Management (PLM) experience, SAP desirable.
  • Other experience in quality management system validations/regulatory and/or compliance audits is preferred
  • Experience in medical device/ pharmaceutical/ IVD are preferred.
  • Previous management or project experience is required.
  • Knowledge and skills typically acquired through previous positions in fast­ paced corporate environments which involved responsibility for similar work.

Supervisory Responsibilities:

  • Talent Acquisition activities which include identifying needs of the department, justification for budget to fill positions, coordinating with HR to market the position, review resumes, conduct interviews and identify and recommend a candidate as the potential hire, and employee orientation to the department and company.
  • Talent Development activities which include developing training plans with employees to ensure they have the necessary expertise to successfully perform their jobs, provide ongoing guidance to employees, and career counseling to help employees develop and advance in their careers.
  • Job Role Definition ensures that job descriptions accurately record the primary responsibilities, qualifications and terms for each job role in their group.
  • Performance Management activities include setting performance standards, ensuring employees have appropriate and realistic job goals, providing ongoing feedback about employees' performance, conducting performance appraisals, including assessing how the employees have performed and how they can improve their performance, developing performance improvement plans if employees' performance is not adequate and providing rewards for employee accomplishments.
  • At higher levels of management, establishing and distributing budgets among departments is required.
  • Ensure employees follow all applicable company policies and procedures


Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. Life at Illumina is about working with teammates who are deeply passionate about what we do, because we know that our work has the power to improve lives. We’re an established company with a track record of phenomenal growth. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.

Basic Function and Scope of the Position:


Responsible for the management of the IIlumina's Quality Compliance program via auditing and CAPA management.




Tasks and Responsibilities:

  • Implement and monitor effectiveness of the quality management system (OMS) strategies, initiatives and objectives established by management.
  • Monitor and apprise management of changes to quality system regulations and requirements. This include staying current on applicable FDA, ISO (including risk management), and other applicable industry requirements applicable to lllumina.
  • Schedule, coordinate, and prepare the Quality Management Review (QMR) presentation, providing the current state of the OMS including post market product review information.
  • Regularly communicate the status of the internal audit program, audit nonconformance reports, NCR actions, documents requiring review/update and CAPA's to management.
  • Implement new and revised processes and documents to continually improve the OMS.
  • Identify, collect, analyze and compare key quality system performance data against established acceptance criteria.
  • Direct and/or conduct investigations into potential quality/compliance concerns. Ensure that root causes of quality system problems are identified and that appropriate preventive I corrective actions are taken. Keep management informed of issues.
  • Manage the Quality Management System (OMS), Internal Audits, and Management Review.
  • Effectively manage the internal audit program through the preparation of the audit schedule, ensuring auditors are qualified, ensuring audits are conducted on time and internal audit NC's are completed on time.
  • Provide GMP and Quality Management System training to the applicable departments.
  • Provide support to the management representative during FDA inspections and external quality audits.
  • Provide support to the Product Evaluation function through entering and closing customer complaints, performing product evaluations, generating reports, and other responsibilities as requested.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.


Preferred Educational Background:

  • University Degree in a scientific discipline or equivalent.
  • Master's and/or PhD preferred.

Preferred Experiential Background:

  • 10+ years related manufacturing environment experience required; preferably GxP
  • > 5 years' experience in project management, configuration management, and/or quality departments within a regulated environment, preferred
  • Good understanding and knowledgeable of FDA regulatory environment (CFR 820), 501k and ISO 13485, CMDR strongly preferred.
  • Experience with process and material change and configuration activities within an Enterprise Resource Planning (ERP) system, SAP desirable
  • Product Lifecycle Management (PLM) experience, SAP desirable.
  • Other experience in quality management system validations/regulatory and/or compliance audits is preferred
  • Experience in medical device/ pharmaceutical/ IVD are preferred.
  • Previous management or project experience is required.
  • Knowledge and skills typically acquired through previous positions in fast­ paced corporate environments which involved responsibility for similar work.

Supervisory Responsibilities:

  • Talent Acquisition activities which include identifying needs of the department, justification for budget to fill positions, coordinating with HR to market the position, review resumes, conduct interviews and identify and recommend a candidate as the potential hire, and employee orientation to the department and company.
  • Talent Development activities which include developing training plans with employees to ensure they have the necessary expertise to successfully perform their jobs, provide ongoing guidance to employees, and career counseling to help employees develop and advance in their careers.
  • Job Role Definition ensures that job descriptions accurately record the primary responsibilities, qualifications and terms for each job role in their group.
  • Performance Management activities include setting performance standards, ensuring employees have appropriate and realistic job goals, providing ongoing feedback about employees' performance, conducting performance appraisals, including assessing how the employees have performed and how they can improve their performance, developing performance improvement plans if employees' performance is not adequate and providing rewards for employee accomplishments.
  • At higher levels of management, establishing and distributing budgets among departments is required.
  • Ensure employees follow all applicable company policies and procedures


Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

Company Overview

Illumina Singapore Pte Ltd
Illumina Singapore Pte Ltd
Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives. We’re an established company with a track record of phenomenal growth. Our revenue grew from $10 million in 2002 to approximately $2.4 billion in 2016. Our growth isn’t just revenue, we’ve been hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its “World’s Smartest Companies” list each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven en