Head of Analytical Testing, Biologics

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:

• Product Control Strategy Support: Act as the QC representative to contribute to the establishment and implementation of the product control strategy from a testing perspective. This includes providing input on setting specifications and ensuring test methods are suitable for the intended control strategy.

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

• Lab Setup: Lead the setup of a bioanalysis laboratory that complies with regulatory requirements.

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

Routine Operation:

• Product Control and Monitoring: Maintain the established product control strategy and lead the monitoring of key product quality attributes to ensure ongoing compliance and product quality.

• Compliance Leadership: Lead the execution and oversight of all testing in accordance with Chinese GMP EU GMP and U.S. cGMP regulations as well as Roche/Genentech standards.

• Methodology Management: Lead the continuous effort to ensure all bioanalytical 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.

• 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 technical expertise and capabilities.

Qualification and Experience

Education/Qualifications

• Bachelors Degree (Life Sciences Pharmaceutical Sciences 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 with a focus on large molecule characterization and quality control strategy. Experience in an MNC Bio-pharma is preferred.

• 3 or more years of people management experience.

• In-depth knowledge of quality control procedures and legal standards with extensive experience in large molecule characterization quality attribute monitoring and validation. Possess hands-on experience in implementing product control strategies.

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

• Familiar with the inspection knowledge of disposable materials relevant hands-on experience is preferred.

• 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.