Clinical QA Audits Manager

hace 1 semana

Sant Cugat del Vallès Barcelona provincia, España Haema A tiempo completo

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Help to grow one of the world’s most innovative companies

We are looking for a Clinical QA Audits Manager who will be part of Sicientific Innovation Office (Instituto Grifols, S.A.).

**What your responsabilities will be**
- Establish audit plans for qualified vendor, investigators site, and clinical department related with the development of clinical studies, including identification of contracted resources as needed, and ensure proper execution according to plan, including review of audit findings with audited entity and/or internal customers and closure of audit findings.
- Review and approve audit reports and inform Clinical QA and Clinical Management of trends or issues related to compliance. Work with Clinical department Managers to identify and address non conformances in a risk-based manner.
- Perform audits to vendors, investigation sites and internal audits related to the development of clinical studies.
- Manage and control the vendor quality system ensuring that it is maintained in compliance with revelant regulations.
- Review and approve the documentation describing procedures relating to the planning, conduct and oversight of clinical audits.
- Work with Clinical departments and project teams to provide guidance and consultancy to resolve compliance issues.
- Assess the readiness of the Clinical departments for regulatory inspections at the study and facility/system levels. Provide clear expectations on improvements where needed.
- Host on-site regulatory inspections as needed.
- Direct and lead staff in the execution of compliance-related activities. Responsible for mentoring and guiding such staff in achieving departmental goals.
- Represent Clinical QA at company meetings or in professional and industry organizations.

**Who you are**
- You have a Ph.D, Master, Bachelors in pharmaceuticals or life sciences related field.
- You have at least 8 years of practical experience in GLP, device and/or GCP quality assurance or compliance activities.
- Your English is advance.
- You are available to travel.

**What we offer**
- Permanent Contract.
- Full Time timetable.
- Location: Sant Cugat. Flexibility for U Plan (home office 2 days a week).
- Attractive Benefits of being part of Grifols team.

Grifols is an equal opportunity employer.

**Location**:mfield6**:cust_building**

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