Head of MSAT

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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 best
• Support Roche's mission of advancing and boldly championing diversity, equity, and inclusion
• Build and maintain strong partnerships with network leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships
• Lead, coach, and guide the team. Manage performance and develop team members to achieve organizational goals and employee personal and professional growth
• Take 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 requirement
• Support PQ activities such Filling line PQ, HVAC PQ, APS etc. to contribution on project delivery
• Setup MSAT management system in alignment with the Roche’s standards, including New product introduction, Tech transfer, Technical Services, Process Engineering
• Establish process validation system and execution to ensure compliance with cGMP requirements and Roche’s quality standards
• Lead SUA design and qualification process to meet the needs of commissioning and qualification
• Lead NPI and organize meeting with global technical functions to ensure product delivery in time
• Setup 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 requirements
• Tech Transfer: Partner with global and site functions to specify, transfer, file and license new products/processes in the plant
• Technical 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 expectations
• Manufacturing 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 preferred
• 6 or more years’ people management experience
• Experienced in strategic project of Aseptic Filling facility including design, commissioning & qualification
• Experienced in new facility startup readiness and operation ramp up including organization, people and operation management system
• Experienced in New Product Introduction, Technical Product Transfer, manufacturing process and investigation management
• Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological and vaccine industry
• Able to think strategically and translate strategies into actionable plans, understands and applies agile ways of working
• Good assertiveness in a global environment and a continuous approach to improvement
• Proven ability to coach and implement lean ways of working Strong creative leadership skills according to the Visionary, Architect, Coach, Catalyst (VACC) model
• Fluent 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.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.