Head of Analytical Testing, Biologics job opportunity at Roche.

Home Jobs In China Tag: Biologics Head of Analytical Testing, Biologics position at Roche


DateMore Than 30 Days Ago bot
Roche Head of Analytical Testing, Biologics
Experience: 5-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Biologics

Copy Link Report
degreeOND
loacation Shanghai, China
loacation Shanghai....China

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 team's 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  Bachelor’s 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 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.

Other Ai Matches

2026 Summer Intern - Pharma Services Applicants are expected to have a solid experience in handling Job related tasks
Operator Central Logistics Services - Kaiseraugst Applicants are expected to have a solid experience in handling Job related tasks
Global Business Process Specialist - Manufacturing Finance & Intercompany (Fixed-term) Applicants are expected to have a solid experience in handling Job related tasks
Study Start Up Specialist Applicants are expected to have a solid experience in handling Job related tasks
Mehrere Laboranten (m/w/d) im Bereich NPC Manufacturing Quality Control Applicants are expected to have a solid experience in handling Job related tasks
Diagnostics Value Consultant(Product Marketing) - Diabetes Care Portfolio Applicants are expected to have a solid experience in handling Job related tasks
Post Doctorate Scientist - Single Cell Technologies Applicants are expected to have a solid experience in handling Job related tasks
QC Techician Applicants are expected to have a solid experience in handling Job related tasks
6-month Internship in Automation Solutions for Antibody Development (m/f/d) Applicants are expected to have a solid experience in handling Job related tasks
Pharmacy Intern Applicants are expected to have a solid experience in handling Job related tasks
Legal Manager Applicants are expected to have a solid experience in handling Job related tasks
Manager, Q&V and Digitalization Quality Applicants are expected to have a solid experience in handling Q&V and Digitalization Quality related tasks
Strategic Alliance Manager - Custom Biotech - LA / San Diego Region Applicants are expected to have a solid experience in handling Job related tasks
People Leader & Assay Architect Applicants are expected to have a solid experience in handling Job related tasks
Ausbildung 2026: Pharmakant:in, Standort Mannheim Applicants are expected to have a solid experience in handling Standort Mannheim related tasks
Cluster Lead - Enterprise Master Data Management Operations Ledger Domain Applicants are expected to have a solid experience in handling Job related tasks
Global Health Policy Team Lead Applicants are expected to have a solid experience in handling Job related tasks
Market Strategy and External Affairs Intern Applicants are expected to have a solid experience in handling Job related tasks
Digital Content & Services Lead Applicants are expected to have a solid experience in handling Job related tasks
生态圈负责人 - 血液治疗领域 Applicants are expected to have a solid experience in handling Job related tasks
Account Executive - GenMark - N. TX, OK, LA, AR, Jackson, MS Applicants are expected to have a solid experience in handling OK, LA, AR, Jackson, MS related tasks
(高级) 产品经理- 乳腺治疗领域 Applicants are expected to have a solid experience in handling Job related tasks
Diabetes Solution Manager Applicants are expected to have a solid experience in handling Job related tasks