Director, Global TRD QA Sterility Assurance

Biopharma Careers; Osterreich; Híbrido; PEN 333.000 - 617.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

Descripción de la vacante

Novartis in Schaftenau, Austria, seeks a leader to establish and continuously develop the TRD QA Sterile Operations Network, providing specialist guidance on sterile and low bioburden processes while ensuring regulatory compliance across modalities.

The role focuses on driving continuous improvement, mentoring team members, and partnering with cross-functional stakeholders to implement best practices, with emphasis on change leadership and quality integrity.

Formación

• Advanced degree in life sciences or pharmacy.
• Extensive experience in sterile manufacturing and quality assurance.
• Strong knowledge of aseptic processing, sterility assurance, and regulatory requirements (e.g., FDA, EMA, ICH).
• Proven 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.

Responsabilidades

• Establish, lead, and continuously develop a TRD QA Sterile Operations Network.
• Provide specialist knowledge and guidance on sterile and low bioburden processes.
• Implement, harmonize, and continuously 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 members of the TRD QA Sterile Operations Network.
• Consult on the evaluation and selection of external contractors for aseptic appropriateness.

Conocimientos

Influence without authority

Relationship-building

Risk-taking

Problem-solving

Communication

Political savvy

Educación

Advanced degree (PhD, MSc, or equivalent) in life sciences, pharmacy, or related field

Descripción del empleo

Location: Schaftenau, Austria

Role Purpose

Establish, lead, and continuously develop the TRD QA Sterile Operations Network, fostering accountability, learning, and collaboration. Provide specialist knowledge and guidance on sterile and low bioburden processes, ensuring compliance with regulatory requirements. Implement, harmonize, and continuously improve aseptic standards and best practices across TRD pilot plants and all modalities (Cell and Gene Therapies, Radioligand Therapies, ADC, and New Biological Entities). Drive continuous improvement, knowledge transfer, and innovation in sterility assurance. Act as a key partner in cross-functional projects, troubleshooting issues and aligning stakeholders on pragmatic solutions and standards. Mentor and develop members of the TRD QA Sterile Operations Network, addressing critical skills gaps. Consult on the evaluation and selection of external contractors for aseptic appropriateness, ensuring integrity of outsourced processes.

Major Accountabilities

• Establish, lead, and continuously develop a TRD QA Sterile Operations Network, fostering accountability, learning, and collaboration.
• Provide specialist knowledge and guidance on sterile and low bioburden processes, ensuring compliance with regulatory requirements.
• Implement, harmonize, and continuously improve aseptic standards and best practices across TRD pilot plants and across all modalities (Cell and Gene Therapies, Radioligand Therapies, ADC, and New Biological Entities).
• Drive continuous improvement, knowledge transfer, and innovation in sterility assurance.
• Act as a key partner in cross-functional projects, troubleshooting issues and aligning stakeholders on pragmatic solutions and standards.
• Mentor and develop members of the TRD QA Sterile Operations Network, addressing critical skills gaps.
• Consult on the evaluation and selection of external contractors for aseptic appropriateness, ensuring integrity of outsourced processes.

Desired skills

• Influence without authority in a matrix environment, build credibility, align stakeholders, and drive standards adoption.
• Pragmatic relationship-building, actively engage cross-functional partners to create momentum for change.
• Pragmatic risk-taking, balance diligence with smart, solution-oriented decision-making.
• Advanced problem-solving, lead troubleshooting and resolution across departmental boundaries.
• Effective communication, tailor messaging, negotiate, and handle pushback diplomatically.
• Political savvy, navigate informal networks and overcome barriers to secure a seat at the table.

Qualifications

• Advanced degree (PhD, MSc, or equivalent) in life sciences, pharmacy, or related field
• Extensive experience in sterile manufacturing, quality assurance, or related areas within the pharmaceutical/biotech industry
• Strong knowledge of aseptic processing, sterility assurance, and regulatory requirements (e.g., FDA, EMA, ICH)
• Proven track record in 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

Benefits & Rewards

• At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
• Expected Annual Base Salary Range for role: €85,300 to €158,300
• The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
• In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
• The rewards of being part of our team go far beyond base pay and incentives.
• We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.
• In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Adjustments for Applicants with Disabilities

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [e-mail] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.