Roche
Head of Manufacturing - Operation Unit
Roche, Shanghai, West Virginia, United States
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 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. Key Responsibilities
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, leading 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 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 an 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 requirement. Lead PQ activities such as Filling line PQ, HVAC PQ, APS etc. to contribute to project delivery. Setup an effective operation system in alignment with Roche’s standards, including manufacturing management system, CCS strategy, production planning system, material management, people training and qualification system. Implement CCS strategy in operation, setup a sustaining sterility assurance program. Build material lifecycle strategy including the key material supplier selection, SUA drawing design, qualifications to meet project needs and no delay risk for commissioning and qualification. Setup team organization structure and people hiring schedule to build a competitive team that meets the project and production ramp up plan. Lead 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 management. Ensure routine operation in compliance with Roche’s GMP/EHS and regulation requirements. Manage operation activities to ensure product delivery in time and within budget. Maintain regular validation activities, such as APS. Continuously monitor deviations and define and implement sustainable measures to reduce deviations. Continuously examine and develop processes and procedures for optimization potential as part of efficiency/technology improvement measures. Continuously monitor budget target and implement control measures, make suggestions for cost optimization and savings. Communicate 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 above. Manufacturing Professional certifications is preferred. Job Required Competencies
12 or more years’ operation experience in the injection 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. Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological and vaccine industry. Biopharma Product lifecycle management knowledge. 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 communication 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.
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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. Key Responsibilities
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, leading 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 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 an 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 requirement. Lead PQ activities such as Filling line PQ, HVAC PQ, APS etc. to contribute to project delivery. Setup an effective operation system in alignment with Roche’s standards, including manufacturing management system, CCS strategy, production planning system, material management, people training and qualification system. Implement CCS strategy in operation, setup a sustaining sterility assurance program. Build material lifecycle strategy including the key material supplier selection, SUA drawing design, qualifications to meet project needs and no delay risk for commissioning and qualification. Setup team organization structure and people hiring schedule to build a competitive team that meets the project and production ramp up plan. Lead 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 management. Ensure routine operation in compliance with Roche’s GMP/EHS and regulation requirements. Manage operation activities to ensure product delivery in time and within budget. Maintain regular validation activities, such as APS. Continuously monitor deviations and define and implement sustainable measures to reduce deviations. Continuously examine and develop processes and procedures for optimization potential as part of efficiency/technology improvement measures. Continuously monitor budget target and implement control measures, make suggestions for cost optimization and savings. Communicate 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 above. Manufacturing Professional certifications is preferred. Job Required Competencies
12 or more years’ operation experience in the injection 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. Strong knowledge of cGMP and regulations relevant to pharmaceutical industry, especially in biological and vaccine industry. Biopharma Product lifecycle management knowledge. 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 communication 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.
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