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The Position

1. Primary Purpose of Job (Job Summary)

Roche is hiring for a greenfield facility in Shanghai and we are looking for an Associate Manager who has strong execution skills and experiences to actively support the manager in establishing operations. Collaborate closely with the project team to execute this strategic initiativeincluding facility design qualification manufacturing readiness and start-up. Additionally the role will oversee daily operations to ensure long-term success while fostering and developing his teams.

The VI Associate Mmanager is responsible for achieving manufacturing goals and providing leadership and oversight to routine operational and administrative activities which occur within the process step i.e. vial Visual Inspection and VI Kits Management. Ensuring products are executed safely and timely in full compliance and consistency with GMP/ SHE requirements and Roches corporate principles quality policies and standards.

• Enable and empower your team to achieve our vision by leveraging creative leadership competencies and exemplifying the Leadership Commitments.

• The role plays a critical part in strategic project realization including facility design qualification and manufacturing readiness and start up.

• The role leads to establishing a solid foundation in the VI process while demonstrating strong on-site execution skills problem-solving abilities to ensure efficient compliant and quality-standard operations.

2. Principle Roles & Responsibilities / Accountabilities

Leadership & People Management

• Build and retain an inclusive workforce and foster an environment where diversity of thought and perspective are valued.

• Maintain an inclusive team that values diversity of thought.

• Maintain strong partnerships with leaders to ensure alignment on strategic projects and daily operations.

• Take the responsibility for department daily SHE management implement site SHE procedure and program and achieve site corporate /site SHE KPI. Promote SHE culture and improve employee safety behavior.

• Manage performance and development team members to achieve organizational goals and employee personal and professional growth.

• Support manager to build a strong pipeline of talent and robust succession plans for key positions.

• Maintain a culture of continuous improvement and model lean leadership principles

• Maintain a culture of transparent high performance empowerment and innovation culture.

Technical

Engineering Project Support and Operation Readiness:

• Participate in new facility design and construction including but not limited to process design equipment selection URS draft or review FAT SAT IOPQ etc. to contribute to project delivery.

• As a key role to establish an effective operation system in alignment with Roches standards including manufacturing system CCS strategy people training and qualification system.

• Assist Packaging Manager to set up team and people hiring schedule to build a competitive team that meets the project and production ramp up plan.

• Lead to establish site Visual Inspection training program and the Kits management procedures and implement it ensure only qualified people perform GMP lots manufacturing.

• Ensure teams competencies in performing the following tasks: Vial Visual Inspection.

• Participate in tech transfer collaboration with other functions to ensure the success of new product manufacturing.

• Represents the facility during regulatory inspections and audits and participates in the response of regulator audit and global quality audit.

• Participate in new facility design and construction including but not limited to process design equipment selection URS review FAT SAT IOPQ VI etc. to contribute to project delivery.

• As a key role support to establish an effective operation system in alignment with the Roches standards including manufacturing system VI process and Kits set up defects category people training and qualification system.

• Lead to establish the procedures related to VI techniques good VI practices on the shop floor and other relevant processes for VI execution.

• Support the packaging manager to establish the VI training program and implement it ensuring only qualified people perform GMP lots manufacturing.

• Ensure teams competencies in performing the following tasks: vial visual inspection.

• Participate in tech transfer collaboration with other functions to ensure the success of new product manufacturing.

Routine Operation:

• Ensure routine operation compliance with regulations and achieve high-quality production standards.

• Ensure total readiness of manufacturing suites including housekeeping machine materials documents and other resources to ensure product delivery in time and within budget.

• Arrange the VI shifts in routine production participate in operation as an VI SME and perform daily review of production batch record deviation according to schedule.

• Lead regular VI operators qualification provide on-the-job training to support formalized technical and GMP training.

• Oversee the daily operation monitoring and maintenance of VI Kits to ensure compliance with VI requirements.

• Supervise VI operations during production and intervene promptly in case of abnormalities.

• Participate in the response of regulator audit and global quality audit as SME during regulatory inspections and audits.

• Raise deviation and involve the root cause investigation including appropriate escalation where needed to ensure closure of deviation within the set timeline.

• Raise change control and provide assessment.

• Participate in Operational Excellence and Continuous Improvement initiatives.

• Related IT system operations such as SAP MES Veeva Cornerstone.

3. Qualification and Experience

Education/Qualifications

• Colleges Degree (Pharmaceutical / Biological is preferred) and above.

Job Required Competencies

• 10 or more years operation experience in the injection pharmaceutical industry MNC Bio-pharma preferred.

• 3 or more years people management experience.

• Experienced in strategic projects of Visual Inspection process including design commissioning & qualification.

• Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry especially in the biological industry.

• Fluent communications skills in English is preferred and the ability to effectively communicate collaborate and foster positive interactions with team members and stakeholders.

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.