Top-Job Quality Manager

Quality Manager (m/f/d)

Diversity-Statement
Überblick
Chiesi Pharmaceuticals GmbH sucht eine Person als Qualitäts Manager:in. Du arbeitest im Bereich Qualitätsmanagement. Du brauchst Erfahrung in Qualitätsmanagement und Pharmakovigilanz. Wichtig sind Englisch- und Deutschkenntnisse, Teamgeist und Eigeninitiative. Ein Hochschulabschluss in Lebenswissenschaften oder einem ähnlichen Bereich ist nötig.
Erstellt mit künstlicher Intelligenz

General Information

Fulltime; all genders

For reasons of better legibility, the simultaneous use of the language forms male, female and diverse (m/f/d) is avoided. All personal designations apply equally to all genders.

Chiesi Pharmaceuticals GmbH is a subsidiary of the internationally successful private company Chiesi Farmaceutici S.p.A. based in Italy, which consistently invests in research and development. Our success is based on our most important values: respect, trust, integrity and sustainability.

For the Austrian affiliate we are looking for an experienced and dedicated Quality Manager to support the achievement of our business objectives while maintaining adherence to relevant regulations and guidelines.

Key Responsibilities

- Strategic Quality Leadership & Process Implementation: Develop and implement a forward-looking quality strategy for Austria in close collaboration with the CEE Hub and Headquarters. Independently and proactively drive the implementation and continuous improvement of relevant quality processes and standards.
- Document Management & SOPs: Proactively manage and archive all quality-related data and documentation according to company policies and regulatory requirements; regular review and further development of relevant SOPs
- Complaint Handling: Manage, collect, and record quality complaints from Austria; communicate with complainants (e.g., healthcare professionals, patients); inform relevant internal teams and escalate critical cases.
- Quality Deviations: Identify and document quality deviations including temperature deviations of medical products; support investigations and CAPA management.
- Risk Management: Ensure quality risk management documentation is complete and maintained.
- Validation & Qualification: Develop and implement validation protocols for equipment, processes, and systems; perform OQ/PQ; document and continuously improve validation activities.
- Self-Inspections: Plan, execute, and report self-inspections according to the annual audit plan; manage CAPAs from self-inspections, including documentation in Trackwise.
- Audits & Inspections: Prepare for local inspections by regulatory authorities; actively participate in audits and inspections, supporting auditors and ensuring compliance.
- Pharmacovigilance: act as deputy for the PV Manager
- Additional Tasks:

- Review promotional materials in accordance with the Pharmig Code of Conduct.

- Manage contract administration for medical contracts (e.g., IITs, donations) in cooperation with the Event Coordination Team, Head of MSLs, Medical Director, and external contract partners.

- Support and accompany medical projects, including background research, literature review, and participation in Ad Boards.

Your Profile

- University degree (BSc, MSc, or equivalent) in Life Sciences, Pharmacy, Medicine, Biology, Quality Management, or a related field
- Several years of experience in the field of Quality Management and/or Pharmacovigilance in the pharmaceutical sector
- In-depth knowledge of regulatory guidelines (GDP, ICH Q9(R1), EMA, AMG, GVP, EFPIA, Pharmig).
- Experience in drafting, implementing, and monitoring SOPs and work instructions.
- Proficient in Microsoft 365, quality and PV databases, and electronic document management systems.
- Fluency in English (spoken and written) and German (for local regulatory and customer interactions).
- Strong communication skills and good team spirit
- Proactive and independent working style
- High sense of responsibility and assertiveness
- Precise, structured and well-organized working style

Additional Information

Chiesi values diversity and inclusion as sources of innovation and creativity. Therefore, we welcome all applications regardless of ethnic origin, age, gender, disability, sexual identity, worldview, or religion.

In addition to attractive benefits, an open, caring and collegial corporate culture and a motivated team, we offer a gross annual salary starting at EUR 62,000; overpayment depending on qualifications and professional experience is possible.

If you are a committed team player and would like to work in an exciting environment, we look forward to receiving your application

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