(Senior) Quality Manager (m/f/d)

Role Overview

Located in Basel, Switzerland, this position is pivotal in overseeing and leading quality initiatives across the TRD portfolio. The primary objective is to ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory standards as outlined in the Novartis Quality Manual. This role emphasizes strategic quality assurance oversight, facilitating quality decision-making, and guaranteeing timely delivery of GMP documentation and project milestones.

Key Responsibilities

• Manage and coordinate complex projects and processes to support TRD product development and departmental goals, adhering to timelines, quality standards, and regulatory mandates.
• Maintain ongoing compliance with cGMP and internal quality standards across all designated activities.
• Act as a Subject Matter Expert (SME), providing QA oversight and functional expertise to TRD units and cross-functional teams.
• Review, approve, and release GMP-related deliverables, including batch disposition for clinical trial materials (IMP), following established authorities.
• Oversee the analysis of master and executed batch records, ensuring prompt rectification of GMP deficiencies and appropriate follow-up actions.
• Author and approve GMP documentation, ensuring precision and adherence to compliance standards.
• Contribute to project teams, providing QA support and acting as an integral team member when necessary.
• Serve as the QA Single Point of Contact (SPOC) for designated Contract Manufacturing Organizations (CMOs).
• Ensure coherence and harmonization of QA responses across TRD QA Operations.
• Assist in internal and external audits and inspections, ensuring preparedness and effective responsiveness.
• Uphold compliance with all relevant quality, safety, ethical, and information security standards.

Preferred Experience

• Background in a GMP environment with a focus on QA practices.
• Experience in batch release, documentation review, and providing inspection support.
• Proven skills in project management within a global matrix organization.
• Familiarity with GMP aspects related to small molecules and new modality pharmaceutics.
• Experience with supplier quality oversight and partnerships with external organizations.

Required Skills

• In-depth understanding of cGMP and regulatory requirements.
• Expertise in scientific and technical quality risk management.
• Solid scientific comprehension of pharmaceutical processes.
• Strong analytical skills with the ability to evaluate GMP compliance effectively.
• Exceptional decision-making, organizational, and project management capabilities.
• Proficient in communication, leadership, and stakeholder engagement.

Language Proficiency

• Fluent in English (both written and spoken).
• Proficiency in the local/site language is desirable.

Commitment to Diversity and Inclusion

Novartis fosters an inclusive work environment that values diversity and aims to reflect the communities we serve.

Why Join Us?

At Novartis, we believe in collaborative innovation to improve the lives of patients and their families. Join a dynamic team where your contributions can lead to meaningful breakthroughs and a brighter future.

Benefits and Rewards

Explore the comprehensive range of benefits designed to help you thrive in both your personal and professional journey.