Head of OIU APAC MSAT

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

• Investigations & Compliance: Lead and direct production investigations and data summarization ensuring all nonconformances and Corrective and Preventive Actions (CAPAs) are completed within appropriate timeframes.
• Issue Management: Proactively identify and respond to technical issues arising during ongoing production; determine root causes and implement sustainable solutions to prevent production interruptions.
• Quality & Change Coordination: Act as the main interface to the Q&R unit for coordinated implementation of product technical changes and represent Global Operations in Product Care and Quality Teams (PCQT).
• Stakeholder Management: Partner and collaborate with APAC Make (MFG QC) MSAT process SMEs and global teams (eg. R&D Q&R LCT) to resolve issues promptly.
• Network Integration: Operate as one network by partnering with global teams and peers at other networks to share investigation best practices and CAPA learnings.

Education

Bachelors degree in a relevant scientific field

Higher education (Masters/PhD) preferred

Qualification & Certification

Requirements of China Medical Device GMP article 8 and IVD section 2.1.1

Experience

6 - 8 years of experience preferably in a regulated industry (Medical Device/IVD) manufacturing Q&R and investigation units

Significant leadership experience and ability to manage complex regional projects

Professional Competencies

Exceptional analytical and root-cause analysis (RCA) skills.

Ability to cope with high pressure complexity and ambiguity.

Proficiency in English and Chinese (Mandarin).

Strong systems thinker with integrated solution-crafting skills.

Leadership competencies at a proficient level in line with the corporate framework.

SHE Responsibility: Please refer to the RDSZ SHE handbook.

GMP Clause: If positions are GMP-related please specify in the job qualification according to the requirements of China Medical Device GMP Article 8 and IVD Section 2.1.1.

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.