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Roche Singapore Technical Operations Pte Ltd

Head of Zero Defect Team

The Opportunity

The Head of Zero Defect Team Manager is accountable for supporting the site toward zero defects by leading a team of change agents. This position requires a leader with strategic thinking, communication, facilitation, negotiation, and influencing abilities, presentation skills, and knowledge of the business. The decisions and actions rendered by this leader will have a cross-functional impact across the site, as well as the success of the network. Overall deviation volume, recurrence towards zero, and improving on-time quality record closure will be key success measures. The Head of Zero Defect Team Manager will report to the Head of Manufacturing in the Manufacturing department.

As the Head of Zero Defect Team, you are responsible for:

Technical and Functional:

Lead and build technical knowledge of the team to drive end to end ownership of deviations, associated remediations, deliver results and continuous improvement for the site in partnership with Quality Assurance team. 

Coach the team through the deviation management process, applying rigor of standard work to perform causal analysis, remediation determination and execution, continuous improvement, and how to influence key stakeholders to successfully manage and remediate deviations to prevent recurrence.

Partner closely with cross-functional teams to ensure accurate fact-finding, timely data collection and effective corrective and preventive actions (CAPA). 

Ensure all deviations are investigated with rigor, scientifically justified, and in compliance with Roche Quality Management Systems and Health Authority requirements.

Analyze deviation trends to identify systemic issues and work with cross-functional teams to implement sustainable preventive strategies proactively.

Establish strategic goals, objectives, KPI and maintain full strategic responsibility for the site and area of accountability. Monitor key performance indicators and drive continuous improvement initiatives 

Serve as a key contributor in inspection readiness and response activities related to deviation handling. 

Lead or support Network initiatives & leverage digital tools (where applicable) to improve the rigor of standard work to perform causal analysis for deviations to ensure robustness, technical writing and storytelling and improve on-time quality record closure. 

Establish, sustain, and leverage effective partnerships with network counterparts to share best practices and influence the design and implementation of our network compliance policies, standards and processes.  

Create an environment of strong team spirit, timely and effective communications, sense of urgency, and high motivation. Inspire the team to achieve goals in the immediate and longer term.

Identify, recruit, manage and develop reporting team members.

Accountable for overall budget for area of accountability.

As a manufacturing leadership team & extended leadership team member, drive collaboration and decision-making within functional, site and across network activities. Influence quality mindset and operational excellence through coaching, feedback, and strong stakeholder engagement. In addition, be an active and visible change agent, promoting flexible and open mindsets to new opportunities.

Safety, Health & Environment:

Comply with all RSTO's Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.

Implement, enforce and take ownership of all RSTO's Safety, Health & Environmental (SHE) requirements and initiatives within his/her areas of responsibilities.

Ensure all employees are competent and provided with the necessary tools and equipment to work safely and without health risks.

Observe all RSTO's site security measures at all times and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

Embody PT Lean Production System (LPS), while fostering and advocating a continuous improvement mindset and culture throughout the organization, by encouraging experimentation and learning.

Who You Are:

Degree in Life Sciences or Engineering discipline or equivalent

8-12 years of related working experience in a cGMP manufacturing environment or equivalent holders with a combination of education and relevant work experience

Minimum 5 years in managing a team in a cGMP manufacturing environment is preferred

Demonstrated ability to lead and influence cross-functional teams in the facilitation of complex problems, driving resolution through sound decision-making & clear, effective communication. 

Demonstrated experience in leading deviation management, root cause investigations, and continuous improvement. 

Strong knowledge of GMP regulations and quality systems. 

Excellent written and verbal communication skills with the ability to present findings and influence cross-functional teams. 

Results-oriented individual with a demonstrated track record of delivering outcomes through accountability, with minimal guidance

Proven ability to drive cross-functional collaboration through trusted & effective relationships to solve complex problems

Lean Six Sigma Certification, Pharmaceutical GMP Professional Certification (CPGP) preferred. 

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.