TRIGA Consulting GmbH & Co. KG

QA Engineer

• Provide functional and disciplinary leadership of a Quality team of approximately 8–10 employees within a defined indication.
• Hold overall responsibility for all product-related quality activities across the entire product lifecycle.
• Develop and implement a comprehensive quality strategy for the assigned portfolio and ensure effective deployment into operational structures.
• Actively contribute to product strategy from a quality perspective in coordination with relevant interface functions.
• Ensure patient safety and regulatory compliance while considering national and international requirements.
• Take responsibility for quality risk management, including identification, assessment and control of quality-relevant risks.
• Establish appropriate measures for early detection of errors and initiate sustainable improvement actions.
• Serve as the central point of contact for quality-related escalations within the portfolio and coordinate cross-functional resolution processes.
• Manage and engage relevant internal and external stakeholders to ensure efficient handling of quality-critical issues.
• Monitor quality-related KPIs and derive appropriate actions for the continuous optimization of product and process quality.

Head of Quality Assurance – Pharma

Compliance

• Independent management of marketing authorization procedures
• Preparation of regulatory submission documentation in eCTD format and submission to authorities
• Life-cycle management (renewals, variations)
• Direct contact with regulatory authorities and point of contact for internal and external RA queries
• Maintenance and optimization of the regulatory information database
• Drafting and review of product information texts

Head of Quality Assurance – Pharma

Regulatory Affairs Manager – Generics