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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 assumes 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) Technical transfer (2) Process Engineering (3) Process validation (4)Manufacturing support

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 MSAT representative to contribute on project design, construction and qualification.Establish appropriate project URS including facilities/utilities and process equipment according to process requirementSupport PQ activities such Filling line PQ, HVAC PQ, APS etc. to contribution on project deliverySetup MSAT management system in alignment with the Roche’s standards, including New product introduction, Tech transfer, Technical Services, Process EngineeringEstablish process validation system and execution to ensure compliance with cGMP requirements and Roche’s quality standardsLead SUA design and qualification process to meet the needs of commissioning and qualificationLead NPI and organize meeting with global technical functions to ensure product delivery in timeSetup team organization structure and people hiring schedule to build a competitive team that meets the project and production ramp up plan

Routine Operation:

Validation: Execute and improve the validation program for processes to ensure compliance with cGMP requirements and Roche’s corporate quality policies and standards requirementsTech Transfer: Partner with global and site functions to specify, transfer, file and license new products/processes in the plantTechnical Services: Respond to and proactively identify issues, determine root cause, and solve forever. Develop, prioritize and drive continuous improvements that reduce safety risks, operational costs, lead times, and scrap/discrepancy rates across all aspects of production.Process Engineering: Establish oversight to ensure production is performed in conformance with license requirements, cGMPs, and Authority expectationsManufacturing Support: Provide technical support to manufacturing organization that includes process and product monitoring, master data and documentation management, compliance to Roche quality systems, and other readiness operational support activities

Qualification and Experience

Education/Qualifications

Bachelors Degree (Pharmacy / Biological Science is preferred) and above

Job Required Competencies

12 or more years’ MSAT experience in the 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 systemExperienced in New Product Introduction, Technical Product Transfer, manufacturing process and investigation managementStrong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological and vaccine industryAble 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.