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Primary Purpose of Job (Job Summary)
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.We are looking for dynamic leaders who can display strong people leadership skills to grow new teams. Previous expertise (10+ years) in 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 will assume accountability of the safe, cost-effective, and efficient operation of manufacturing. Overall responsible for the smooth and efficient running of the site with Roche’s goal & strategy, in full compliance and consistency with GMP/SHE requirements and Roche’s corporate principles, quality policies and standards.This position also ensures market demands are met, in adequate time and quantities.
● The role will ensure a close collaboration/engagement with the global organization/global manufacturing network.
Principle Roles & Responsibilities / Accountabilities
(Major functions of the position)
Leadership & People Management
● Bring Creative Leadership to life at scale, through visionary, architect, catalyst and coach roles, to ensure long term high performance 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.
● Build and retain an inclusive workforce and foster an environment where diversity of thought and perspective are valued.
● 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 SHE management, Promote SHE 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 environments in accordance with company culture.
Technical
● Orchestrate end-to-end production operations to maximize output and labor efficiency while strictly adhering to safety (SHE) and quality standards. Define and execute production strategies to ensure all site goals—including productivity, safety, and financial targets—are met within budget.
● Champion a culture of strict cGMP compliance and maintain a perpetual state of inspection readiness for all reporting departments. Ensure the rigorous implementation of all Standard Operating Procedures (SOPs) and act as a key interface during regulatory inspections to guarantee operational legitimacy.
● Manage operational activities to guarantee the on-time delivery of products. Oversee the development of production schedules and coordinate closely with maintenance and supply chain teams to ensure planned production runs without delay or interruption.
● Ensure the production of high-quality products in alignment with the Pharmaceutical Quality System (PQS), including robust management of DMS, CAPA, and QRM. Continuously monitor deviations, promoting a culture of proactive problem prevention and implementing sustainable measures to minimize recurrence.
● Represent manufacturing in defining and refining validation strategies, investigations, and technical transfers. Maintain regular validation activities and ensure the validated state of all processes and plants within the production area.
● Drive the continuous improvement of manufacturing procedures and equipment in collaboration with MSAT and Quality functions. Proactively examine processes for optimization potential and implement efficiency/technology improvement measures to elevate operational performance.
● Accountable for the production budget target; continuously monitor financial performance and implement effective control measures. Proactively identify and execute cost optimization initiatives and savings opportunities without compromising quality or safety.
● Ensure the effective operation of the production management training system. Oversee that all personnel receive necessary initial and ongoing training tailored to actual needs, ensuring staff are appropriately qualified and assessed for the activities they perform.
● Communicate effectively with global functions and network teams to ensure operational requirements align with global standards. Leverage global experience and share local insights to adopt best practices and drive standardization across the network.
● Supervise the sanitation, hygiene, and maintenance conditions of the plants to keep premises and equipment in optimal working condition. Ensure batch production and packaging records are reviewed accurately and submitted to Quality Management promptly to support efficient product release.
● Supervise contract manufacturing, including fulfilling production management responsibilities related to contract manufacturing, ensuring that contract-manufactured drugs are produced and stored according to approved processes, and guaranteeing the quality of the manufactured drugs.
Qualification and Experience
Education/Qualifications
● Bachelors Degree (Pharmacy is preferred) and above
● Manufacturing Professional certifications is preferred
Job Required Competencies
● 12 or more years’ operation experience for oral solids manufacturing in the pharmaceutical industry, MNC Pharma preferred
● 6 or more years’ people management experience
● Strong knowledge of cGMP and regulations relevant to the pharmaceutical 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
● Bring Creative Leadership to life at scale, through visionary, architect, catalyst and coach roles
● Fluent communications skills in English and the ability to effectively communicate and influence across all levels of the organization
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.