Process Control & Sterility Assurance Manager (m/w/d)

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For a successful production site at Kaiseraugst, Engineering Science and Technology (ES&T) advances and enables innovation and improvement using science, technical knowledge, and predictive services. Our key success factors for sustainable and compliant asset performance are continuous process improvement, agile employees, and passion.

As Process Control and Sterility Assurance Manager, you will be responsible for the End-to-End Oversight of Manufacturing Process Controls and Sterility Assurance Coaching at Kaiseraugst . In addition you will globally represent the site within the PT network. You will also lead and manage an interdisciplinary squad that proactively invests time and resources to improve robustness of our processes and execute process controls. You closely collaborate with the Contamination Control Strategy Manager in Kaiseraugst to ensure overall compliance to the Manufacturing Control requirements. You are the primary contact for interaction with Health Authorities regarding process controls and related technologies and processes during inspections and scientific advice meetings.  

In this role, you will report to the Head of Engineering Science & technology in Kaiseraugst and be part of the ES&T leadership team.

The Opportunity:

• Responsibility for the End-to-End Process Controls (according to Roche Pharma requirements for manufacturing controls in compliance with health authority requirements for Good Manufacturing Practices (GMP) manufacturing facilities) in Kaiseraugst 

• Advancing and improving the Sterility Assurance and Aseptic Behaviour within Kaiseraugst and the PT network and fostering harmonization between the sites

• Implementing, managing, and leading the Kaiseraugst Process Control squad and establishing a respective governance structure

• Conceptualize, implement, oversee, and maintain an overall approach for Production Records Lifecycle, Overall Hold Time (e.g., Time Out of Refrigeration, Light exposure) concept and Aseptic Process Simulation concept and reporting, Container Closure Integrity concept and controls as well as sterile consumables (single use Equipment, Filter etc.), Alarm Handling concept for manufacturing in Kaiseraugst, Holistic Aseptic Training concept and provide deep coaching to the manufacturing teams, Optical Inspection

• Act as a coach for the respective Owners of the above mentioned process control elements - presence on the floor, troubleshooting, and deviation handling

• Planning, prioritizing, and coordinating continuous improvement activities for the process control elements by introducing ideas to improve quality and overall process control

• Representation of the End-to-End process controls, Sterility Assurance controls, and related sub-processes in health authority inspections and audits, including boosting inspection readiness and follow-up

• Close cooperation with partners in ES&T, the manufacturing organization, and QA at the site Kaiseraugst, as well as strategic partners (e.g.,regulatory, global MSAT, global Quality etc.) in the PT network, ensuring an excellent flow of information

• Role modeling agile mindset and liaising with relevant global stakeholders (e.g.,Pharma Quality System working squads, global Quality and Auditing, network team for aseptic processing) as well as health authorities to deliver a cGMP-compliant future-oriented concept - authoring and reviewing relevant registration dossier sections, SPOC for the PT network and inspections

Who you are:

• A master's degree in pharmaceutical or life science, chemistry, biology, or engineering (preferably with postgraduate training or doctorate) with profound professional experience in aseptic pharmaceutical production, process validation, sterility assurance, or process development and excellent knowledge of relevant health authority requirements and experiences in executing registration-relevant technical changes as well as health authority inspections and audits

• Proven successful delivery of cross-functional projects and project management skills

• Ability to effectively communicate and influence others across all levels of the organization (fluent verbal and written communication skills in German and English)

• Experience in the field of validation and a proven ability to reduce complexity and sound stakeholder management

• A fundamental, working understanding of safety, quality systems, and quality assurance concepts are required, including the application of current Good Manufacturing Practices (cGMPs)

• An entrepreneurial and systemic way of thinking with a view of the overall process (“end to end”) and the ability to consistently perform at a high level in a constantly changing environment

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 Kaiseraugst is a cornerstone of Roche's global production and logistics network. It employs some 1900 people out of the 10,700 employees at our Basel/Kaiseraugst site and is Roche's largest and most innovative packaging facility worldwide. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.