The Opportunity:
As the Head of MSAT, you will ensure the site’s Right to Operate and drive manufacturing excellence by providing technical support for safe, high-quality, and continuously improving production. Your responsibilities include monitoring, analyzing, optimizing, and validating ongoing operations, as well as resolving production issues. You will collaborate with internal and external partners to transfer, implement, validate, and maintain new and existing products/processes. This role reports to the Site Head.
As the Head of MSAT, you will be responsible for:
Leadership & People Management:
- Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
- Establish strategic goals and objectives and maintain full strategic responsibility for the MSAT organization.
- As a site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
- Accountable for overall budget and financial performance of the MSAT organization.
- Proactively promote positive Safety Culture and cGMP operating principles.
Technical:
● Ensure Right to Operate through compliance with cGMP and regulatory
requirements applicable to the department.
● Direct areas of responsibility:
- Validation: Own, execute and improve the validation program for equipment, processes, and cleaning, and ensure compliance with PQS and HA requirements. Represent Validation program during HA inspections.
- Automation: Own, integrate, maintain and improve all production automation platforms at the site, and ensure compliance with PQS and HA requirements.
- Tech Transfer: Partner with global and site functions to specify, transfer, file and license new products/processes in the plant.
- Process Engineering: Establish oversight to ensure production is performed in conformance with license requirements, cGMPs, and global Health Authority expectations, and represent state of compliance during Health Authority inspections. Drive continually monitoring of process to implement continuous improvement process.
- 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.
- For specific sites: Pilot Plant Operations: Build and maintain pilot plant operations to support Make-Assess-Release activities, tech transfers, and continuous improvement of the production plant. Launch and PTD partner.
● Operate as one network: Partner with global MSAT teams and network peers at other manufacturing sites to share and adopt best practices across the network that drive continuous improvement in all technical aspects of production.
● Serve as a core member of the relevant Technical Council, provide site contributions to network technology roadmaps, ensure funding and execution of assigned projects on the respective site level.
Safety, Health & Environment:
● Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
● Implement, enforce and take ownership on all RSTO’s Safety, Health & Environmental (SHE) requirements and initiatives within his/her areas of responsibilities.
● Ensure all employees are competent and provided with the necessary tools and equipment to work safely and without health risks.
● Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.
Lean Production System:
● Embody PT lean leadership principles and methods while fostering a continuous improvement mindset.
Who You Are:
- Degree required in (Science or Engineering) discipline or equivalent with a minimum 17 or more years’ of related working experience or equivalent holders with combination of education and relative work experience is preferred.
- 6 or more years of people management experience in managing direct and indirect of workforce (>20 individuals) is preferred.
- 4 or more years’ relevant engineering or project management experience in the pharmaceutical industry and/or a cGMP environment is preferred.
- Extensive experience with start-up and validation of manufacturing equipment, utility and process systems, including requirements for documentation and testing.
- Expert knowledge of clean room or classified area design/requirements with deep process, equipment, automation, validation and technical knowledge.
- Possesses strong verbal and written communication skills and the ability to influence at all levels to build trustful and effective relationships.
- Able to think strategically and translate strategies into actionable plans.
- Takes responsibility, drives results, and achieves expected outcomes.
- Additional requirements may be specified by site and local needs.
