TRD QA Global Sterility Assurance

Novartis Pharma Schweiz AG seeks a Senior TRD QA Global Sterility Assurance specialist in Schäftenau to lead sterile operations networks and ensure regulatory compliance across advanced therapy modalities.

This position is responsible for establishing and guiding a global network dedicated to sterile quality assurance within the Translational Research & Development (TRD) division. The role focuses on harmonizing aseptic standards across various therapeutic areas, including cell and gene therapies, while providing expert guidance on low bioburden processes to meet strict regulatory expectations.

Responsibilities

• Foster a culture of accountability and continuous learning within the TRD QA Sterile Operations Network.
• Lead the development and improvement of aseptic standards and best practices across pilot plants and diverse modalities.
• Serve as a central partner in cross-functional initiatives, resolving technical issues and aligning stakeholders on practical solutions.
• Mentor network members to bridge critical skill gaps and promote knowledge transfer.
• Evaluate external contractors to ensure their aseptic processes meet integrity and appropriateness standards.
• Drive innovation and continuous improvement in sterility assurance methodologies.

Requirements

• Advanced degree in life sciences, pharmacy, or a closely related discipline.
• Substantial professional experience in sterile manufacturing or quality assurance within the pharmaceutical or biotech sectors.
• Deep understanding of aseptic processing, sterility assurance principles, and relevant regulatory frameworks such as FDA, EMA, and ICH guidelines.
• Proven ability to lead cross-functional teams or networks, preferably within a matrix organizational structure.
• Strong capacity to influence outcomes and drive change without direct authority.
• Excellent problem-solving capabilities alongside superior communication and stakeholder management skills.
• Fluent proficiency in English.

Nice to have

• Proficiency in additional languages beyond English.

What the company offers

• Performance-based bonus tied to specific performance metrics.
• Comprehensive insurance coverage options.
• Retirement and pension plan contributions.
• Access to wellbeing resources and support.
• Global recognition programs for employee achievements.
• Hybrid working arrangements where operationally feasible.
• Minimum of 14 weeks of paid parental leave.

About the company

Novartis Pharma Schweiz AG is dedicated to reimagining medicine together, focusing on collaborative efforts to advance healthcare solutions and improve patient outcomes through innovative research and development.

• Commitment to collaborative innovation in medicine.