Global Sterile QA Leader - TRD Operations Network

Novartis AG; Tirol; Hybrid; EUR 85,000 - 158,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

Parental leave (14 weeks)

Job summary

Novartis is seeking a leader to establish and continuously develop a TRD QA Sterile Operations Network in Austria. You will provide expert guidance on sterile and low bioburden processes, ensuring regulatory compliance across all modalities.

You will harmonize aseptic standards, drive improvement, mentor team members, and collaborate with cross-functional partners to solve complex issues and advance sterility assurance.

Qualifications

• Advanced degree in life sciences, pharmacy, or related field.
• Extensive experience in sterile manufacturing, quality assurance, or related areas in pharma/biotech.
• Strong knowledge of aseptic processing, sterility assurance, and regulatory requirements (FDA, EMA, ICH).
• Proven track record leading cross-functional teams or networks, ideally in a matrix environment.
• Demonstrated ability to influence without authority and drive change across organizational boundaries.
• Excellent problem-solving, communication, and stakeholder management skills.
• Fluent in English; additional languages a plus.

Responsibilities

• Establish, lead, and continuously develop a TRD QA Sterile Operations Network.
• Provide specialist knowledge on sterile and low bioburden processes with regulatory compliance.
• Implement, harmonize, and improve aseptic standards across TRD pilot plants and modalities.
• Drive continuous improvement, knowledge transfer, and innovation in sterility assurance.
• Act as a key partner in cross-functional projects, troubleshooting issues and aligning stakeholders.
• Mentor and develop TRD QA Sterile Operations Network members to address skills gaps.
• Consult on selecting external contractors for aseptic appropriateness and outsourced processes.

Skills

Influence without authority

Cross-functional collaboration

Problem-solving

Stakeholder management

Communication skills

English fluency

Education

Advanced degree (PhD, MSc, or equivalent)

Job description

Novartis is seeking a leader to establish and continuously develop a TRD QA Sterile Operations Network in Austria. You will provide expert guidance on sterile and low bioburden processes, ensuring regulatory compliance across all modalities.

You will harmonize aseptic standards, drive improvement, mentor team members, and collaborate with cross-functional partners to solve complex issues and advance sterility assurance.