Operational Aseptic Assurance Lead and Owner of the Contamination Control Strategy (CCS)

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With its 1,500 employees, the Kaiseraugst production center (Pharma Technical Operations Manufacturing) ensures uninterrupted patient care with high-quality medicines. We stand for the highest pharmaceutical manufacturing standards, Roche's largest, most innovative packaging center, and serve more than 120 countries.

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.

For a successful production site at Kaiseraugst, Engineering & SHE drives innovation and improvement through scientific expertise, technical knowledge, and predictive services. Our key success factors for sustainable and compliant asset performance include process excellence, committed employees, and a passion for quality.

As the Operational Aseptic Assurance Lead and Owner of the Contamination Control Strategy (CCS), you will play a pivotal role in ensuring the integrity of aseptic manufacturing processes and maintaining contamination control standards that safeguard the sterility of our drug products.

• Develop, maintain, and continuously improve the site-wide CCS in accordance with regulatory requirements (e.g., Annex 1) and industry best practices.
• Oversee the CCS governance structure to ensure clear assignment of responsibilities as well as clear and comprehensible processes for maintaining and improving the Contamination Control status
• Ensure that the CCS is implemented effectively across departments and production units, including regular training
• Maintain constant control and visibility of CCS effectiveness, raise relevant matters with senior management and define and drive necessary actions for maintaining and improving the Contamination Controls
• Provide expert knowledge during change assessments to ensure regulatory compliance and to evaluate the potential impact on the CCS

• Liaise closely with the Aseptic Coaches and other relevant local and global functions and stakeholders in advancing and improving Aseptic Assurance and Aseptic Behaviour within Kaiseraugst and the PT network.
• Globally represent the site within the PT network, for example, as part of the Aseptic Processing Community, the global Annex 1 Implementation Team, as well as the Global CCS team; be the primary point of contact for all relevant global interfaces, e.g., global aseptic assurance.

Audit and Inspection Support:

• In close cooperation with other functions, act as the point of contact regarding Aseptic Assurance and Contamination Control during inspections and audits
• Ensure that inspection and audit findings are being addressed to the full extent by providing a holistic view

In this role, you will report to the Head of Engineering & SHE (E&S) in Kaiseraugst and be part of the E&S leadership team.

You possess a master's degree in pharmaceutical or life sciences, chemistry, biology, or engineering, along with extensive professional expertise in aseptic pharmaceutical production. Moreover, you have accumulated over 10 years of practical experience in the manufacturing of sterile dosage forms, having undertaken diverse roles across areas such as Manufacturing, Quality Control (QC), Quality Assurance (QA), and Manufacturing Science and Technology (MSAT).

• You have proven expertise in interpreting and implementing global regulatory requirements and guidelines (e.g., EudraLex Annex 1, PDA Technical Reports, ISO Standards, PIC/s, WHO, ISPE guidelines).
• You demonstrate a strong quality and compliance mindset.
• You have experience participating in audits and inspections, particularly in a Subject Matter Expert (SME) role, providing critical expertise and ensuring full compliance with regulatory standards.
• You possess outstanding verbal and written communication skills in both German and English, with the ability to effectively influence and collaborate across all levels of the organization.
• You embrace an entrepreneurial and systemic approach, with end-to-end process thinking that allows you to navigate and perform successfully in a fast-paced and constantly evolving environment.

If you are looking for an impactful leadership role where your expertise in sterility assurance and contamination control can drive both operational excellence and regulatory compliance, we look forward to meeting you.

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.