Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The PositionPrinciple Roles & Responsibilities / Accountabilities

In order to enable Roche’s expanding in Shanghai with growing Drug Product operations, the role of Quality Head for Biologics assume below primary purposes:

Plays a critical part in strategic project realization from Quality and Compliance perspective, to bring investments through qualification into steady state operations by providing quality support and governance to facility design, qualification and manufacturing readiness and start up.Oversees the quality and compliance operations and relevant business processed in Biologics manufacturing site. This is ensured by implementing, executing and monitoring of Global Quality Standards (PQS), global quality strategy and corresponding Health Authorities Requirements.The role is part of China Quality Leadership Team reporting to Quality Head China, also joins the Biologics manufacturing Site Leadership Team being accountable for Quality and Compliance aspects of Biologics manufacturing site. This position also takes the role as the Qualified Person of Biologics company.Enable and empower the quality operation team to deliver the vision and goals through demonstrating VACC (Visionary, Architect, Coach, Catalyst) leadership behaviors and focusing on strategic project development in China.

Organization and People Management Responsibilities

Ensuring the adherence to the Global Quality Strategy and Goals. Establish strategic goals and objectives and maintain full strategic responsibility for the quality organization in the Biologics manufacturing site.As a member of China Quality Leadership Team and Site Leadership Team, drive cross-team collaborations, network activities and alignment.Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.Ensuring adequate resources, talent management, employee development and succession planning, hiring/promotions, compensations etc.Accountable for the financial performance of the site quality organization.Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.Embody PT lean leadership principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.

Quality Management Responsibilities

Engineering Project Support and Operation Readiness:

Plays the role of quality representative to contribute on project design, construction and qualification.Quality review of project URS including facilities/utilities and process equipment according to process requirement Quality review of PQ activities such as Filling line PQ, HVAC PQ, APS etc. to contribution on project deliverySetup an effective Quality team in alignment with the Roche’s standards and Health Authorities Requirements, and also ensure the resources efficiency by leveraging the China Quality OrganizationSetup team structure and people hiring schedule to build a competitive team that meets the project and production ramp up planLead quality operation readiness including quality assurance and quality control to ensure product delivery in an efficient and safe manner and in accordance with cGMP

Routine Operations: Take the role of Quality Responsible Person and Qualified Person for Biologics companyEnsuring that all relevant activities associated with Manufacturing, Analysis and Release comply with global standards and meet cGMP and Regulatory compliance and corresponding reporting requirements.Execution of strategic plans, goals and resource allocation as defined by the Global and China Quality Unit or specific for the siteCollaborate with other Quality teams in China and manage quality operation activities efficiently to ensure product delivery in time and within budgetEnsuring the executions and records of quality systems including Deviations, CAPAs, Change Controls, GMP trainings, and other related comply with global PQS and Chinese regulationsEnsuring the executions and records of qualification / validation activities comply with global PQS and Chinese regulationsEnsuring the quality control testing of materials and products comply with global PQS and Chinese regulationsResponsible for quality management review for the site by applying the respective metric and escalation of critical quality and compliance incidents and topics timelyOversight the site quality and compliance risk assessment

Qualification and ExperienceEducation/QualificationsScience Bachelor degree or abovePharmaceutical, Chemistry, Biochemistry, Analysis or relevant disciplines

Leadership CompetenciesLeads by exampleStrong leadership, teamwork and management skillsSolid Talent and organizational developmentFluent communications skills in English and the ability to effectively communicate and influence across all levels of the organization

Job Required Competencies12 or more years’ work experience in the pharmaceutical or related industry, MNC pharma preferred6 or more years’ people management experience5 or more years’ manufacturing or quality management experience in the pharmaceutical industryStrong knowledge of cGMP and regulations relevant to biological pharma, biological aseptic experience is requiredExperience in strategic project deployment or new quality organization set up is preferred

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.