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.

The Position

Roles & Responsibilities

Engineering Project Support and Operation Readiness:

• CCS Support: Support the establishment of the Contamination Control Strategy (CCS) for the aseptic production line.

• Environmental Monitoring (EM): Support EMPQ and establish risk based environmental monitoring strategy and ensure its effective implementation.

• Microbiology Method Validation: Responsible for the validation of microbiology methods including supporting the confirmation of cleaning and disinfection processes and the efficacy of disinfectants.

• Lab Setup: Lead the setup of a microbiology laboratory that complies with regulatory requirements and build a BSL-II (Biosafety Level 2) lab management system.

• Equipment Support: Support the Performance Qualification (PQ) of laboratory equipment and ensure routine operation.

Routine Operation:

• Compliance Leadership: Lead the execution and oversight of environmental monitoring and critical facility testing in accordance with Chinese GMP EU GMP U.S. cGMP regulations and Roche/Genentech standards.

• Methodology Management: Lead the continuous effort to ensure all microbiological test methods are validated and that their validation status is maintained as effective.

• Audit Readiness: Be accountable for audit readiness by ensuring compliance with effective standards and regulatory/statutory guidelines. Actively lead the teams response to regulatory inspections and global quality audits.

• CCS and Training: Drive the continuous support of the effectiveness of the Contamination Control Strategy (CCS) and lead the organization of microbiology-related training.

• Product Release Leadership: Be accountable for product release testing ensuring timely delivery according to lead time requirements and guaranteeing compliance with Data Integrity (DI) standards.

• Team Development: Lead the development of a competent team through coaching mentoring and training by having a skills competencies development and appraisal program in place to strengthen the technical expertise and capabilities.

Qualification and Experience

Education/Qualifications

• Bachelors Degree (Life Sciences Microbiology or Analytical Sciences is preferred) and above

• Special Equipment management certification

Leadership Competencies

• Take a genuine interest in people

• Listen carefully tell the truth and explain the why

• Empower and trust people to make decisions

• Discover and develop the potential in people

• Strive for excellence and extraordinary results

• Set priorities and simplify work

• Congratulate people for a job well done

Job Required Competencies

• 5 or more years of QC experience QC experience with a focus on microbiology and aseptic processes. MNC Bio-pharma experience is preferred

• 3 or more years of People management experience

• In-depth knowledge of quality control procedures and legal standards with extensive experience in aseptic assurance and microbiological testing. Possess hands-on experience in Contamination Control Strategies (CCS) and Environmental Monitoring (EM) control strategies.

• Advanced knowledge of regulatory requirements in the industry. Experience with compliance inspection by NMPA/FDA/EMA/TGA/PMDA.

• Experienced in strategic project of QC design commissioning & qualification. Experienced in QC new facility startup readiness and operation ramp up including organization people and operation management system.

• Able to think strategically and translate strategies into actionable plans understands and applies agile ways of working

• Fluent communications skills in English and the ability to effectively communicate collaborate and foster positive interactions with team members and stakeholders.

Who we are

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.