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The Position

Roche is hiring for an expanding operation in Shanghai and is seeking to expand its site leadership team, with growing Drug Product operations. We are looking for people who have significant experience in Sterile Drug Product operations, in a leadership position, who can bring investments through qualification and into steady state operations. These are new roles in Roche and we are looking for
Dynamic leaders who can set up operations, whilst also displaying strong people leadership skills to create and grow new teams. Previous expertise ( 10+ years ) in sterile pharmaceutical manufacturing operations, where work takes place in a highly automated environment and having a site leadership position whilst operating in a regulated, China and overseas regulatory environment is an advantage.

Enable and empower your team to deliver our vision through demonstrating VACC (Visionary, Architect, Coach, Catalyst) leadership behaviors and focusing on strategic project development in China.The role plays a critical part in strategic project realization including facility design, qualification and manufacturing readiness and start up.The role will assume accountability of the routine operations. Overall responsible for the smooth and efficient running of the site with Roche’s goal & strategy, in full compliance and consistency with GMP/ EHS requirements and Roche’s corporate principles, quality policies and standards.The role will ensure a close collaboration/engagement with the global organization / global manufacturing network.Be part of the Site Leadership Team and report to the Site Head, will lead the following functions:(1) Formulation (2) Filling (3) Packaging (4) Production Planning

Principle Roles & Responsibilities / Accountabilities

Leadership & People Management

Strong creative leadership skills according to Visionary, Architect, Coach, and Catalyst (VACC) model and shown ability to build forward -thinking outlook; remove barriers, develop people and technical capabilities; build an environment which enables people to perform at their bestSupport Roche's mission of advancing and boldly championing diversity, equity, and inclusionBuild and maintain strong partnerships with network leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationshipsLead, coach, and guide the team. Manage performance and develop team members to achieve organizational goals and employee personal and professional growthTake the responsibility for daily EHS management, Promote EHS culture and improve employee safety behavior.Build a culture of continuous improvement and operational excellence,Build a strong pipeline of talent and robust succession plans for key positions.Create open, transparent, caring and safe working environment in accordance with company culture.
 

Technical

Engineering Project Support and Operation Readiness:

Plays the role of operation representative to contribute on project design, construction and qualification.Establish appropriate project URS including facilities/utilities and process equipment according to process requirementLead PQ activities such Filling line PQ, HVAC PQ, APS etc. to contribution on project deliverySetup an effective operation system in alignment with the Roche’s standards, including manufacturing management system, CCS strategy, production planning system, material management,  people training and qualification systemImplement CCS strategy in operation, setup a sustaining sterility assurance programBuild material lifecycle strategy including the key material supplier selection, SUA drawing design, qualifications to meet project needs and no delay risk for commissioning and qualificationSetup team organization structure and people hiring schedule to build a competitive team that meets the project and production ramp up planLead operation readiness to ensure product delivery in an efficient and safe manner and in accordance with cGMP

Routine Operation:

Take the role as head of production managementEnsure routine operation in compliance with Roche’s GMP/EHS and regulation requirementsManage operation activities to ensure product delivery in time and within budgetMaintain regular validation activities, such as APSContinuously monitor deviations and define and implement sustainable measures to reduce deviationsContinuously examining and developing processes and procedures for optimization potential as part of efficiency/technology improvement measuresContinuously monitor budget target and implement control measures, make suggestions for cost optimization and savingsCommunicate with the global function and relative teams to ensure that operational requirements meet global requirements, share experience with global to leverage the same practice

Qualification and Experience

Education/Qualifications

Bachelors Degree (Pharmacy/ Biological Science is preferred) and aboveManufacturing Professional certifications is preferred

Job Required Competencies

12 or more years’ operation experience in the injection pharmaceutical industry, MNC Bio-pharma preferred6 or more years’ people management experienceExperienced in strategic project of Aseptic Filling facility including design, commissioning & qualificationExperienced in new facility startup readiness and operation ramp up including organization, people and operation management systemStrong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological and vaccine industryBiopharma Product lifecycle management knowledgeAble to think strategically and translate strategies into actionable plans, understands and applies agile ways of workingGood assertiveness in a global environment and a continuous approach to improvementProven ability to coach and implement lean ways of working Strong creative leadership skills according to the Visionary, Architect, Coach, Catalyst (VACC) modelFluent communications skills in English and the ability to effectively communicate and influence across all levels of the organization

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.