Shanghai, Shanghai, China's Mainland
5 days ago
QC Head, 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

Technical and Functional Responsivities

Ensure the readiness of QC organization and labs per project timeline, including but not limit to hiring, QC facility & equipment, IT systems & digitalization, materials, methods and procedures.Lead analytical transfers and local analytical method verifications as required according to project timeline and ensuring the adherence to relevant HA regulations and Roche standards.Establish, modify, implement and enforce Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche standards, policies, plans, objectives and procedures.Ensure adequate resources and analytical capability. Provide QC staff with technical guidance on test methods and relevant procedures. Lead the team to build up analytical capability for biologics to further support local biologics business.Ensure that data, documentation, and laboratory processes are in a constant state of regulatory compliance and inspection readiness.Direct the review and approval of all applicable Quality Control documents and ensure documents are updatedLead the QC team to resolve issues in a timely manner, including discrepancies, investigations, and implementation of corrective and preventative actions (CAPA).Escalate potential quality issues identified during QC readiness and related testing, particularly quality or regulatory issues that could impact the delivery of project, product quality or regulatory compliance.Support regulatory inspections and internal audits, as well as approval of protocols and reports from external QC laboratories.Coordinate with regulatory authorities and external sources and network partners regarding issues affecting product quality

Leadership and People Management Responsibilities

Be able to build a capable and strong bioanalytical QC team.Create an environment with strong team spirit, timely and effective communication, sense of urgency and high motivation, and inspire teams to achieve short-term and long-term goals.Be an active and visible change agent and promote a flexible and open attitude towards new opportunities.As a senior leader, to drive networking activities, cross-functional collaborations and decision making. Be responsible for the overall budget and financial performance of the QC team.Take proactive measures to promote a positive safety culture and ensure all applicable safety, health and environmental requirements are met in accordance with company policies and local legal requirements.Embody Pharma Technical (PT) Lean principles and methodologies and promote a continuous improvement culture throughout the organization by encouraging experimentation and learning.

Qualification and Experience

Science Bachelor degree or above.Pharmaceutical, Chemistry, Biochemistry, Analysis or relevant disciplines.Leads by example.Strong leadership, teamwork and management skills.Solid Talent and organizational development.10 or more years’ work experience in the pharmaceutical or related industry, MNC pharma preferred.5 or more years’ people management experience.Strong knowledge of biologics analytical science and technology, cGMP regulations relevant to biologicallevels of the organization and networkFluent communications skills in English and the ability to effectively communicate and influence across all Experience in strategic project deployment or new QC organization set up is preferred

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.

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