Clinical and Pv Quality Assurance Manager

vor 5 Monaten

Genf GE, Schweiz OM Pharma Ltd. Vollzeit

Location: Meyrin, Geneva, CH- Division:
- Division: Quality- Job Type: Permanent role

We are recruiting a** Clinical and PV Quality Assurance Manager **at our headquarters and biotech production site in Geneva. Reporting to the Head of Quality Management, your mission is to ensure that our Clinical and Pharmacovigilance Quality Assurance system meets standards expected by health authorities and global regulatory authorities.

Your main responsibilities are as follows:

- Ensure timely planning, management and execution of risked based CQA - PVQA audit programs (all type of audits including self inspections)
- Implement measures to ensure inspection readiness of Clinical, Pharmacovigilance, Regulatory and Medical activities
- Lead Quality Risk Management Plan for Clinical, Pharmacovigilance, Regulatory and Medical activities.
- Lead GCP and PV Regulatory Inspections
- Oversee/support the management and escalation of Critical Quality Issues and Serious Breaches
- Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance.
- Improve quality systems, priorities and timelines in Clinical and Pharmacovigilance Quality Assurance frame
- Work closely with our clinical teams to support our sponsored clinical trials
- Manage third party service providers

To carry out this mission, we are looking for a person with the following profile:

- Academic degree in health sciences or related field
- At least 3 years of experience in Clinical and PV Quality Assurance in the pharmaceutical industry and/or CRO
- Extensive understanding of interpretation for FDA, EUand ICH regulations (GCP). CFDA is a plus.
- Experience of planning, managing and executing PV and GCP audits
- Fluent in English with gool oral and written skills in French

You are an experienced team player who enjoys working in a fast paced, hands-on and flexible environment. Thanks to your communication and interpersonal skills, you know how to establish collaborative links with different stakeholders. You like to take a step back to analyze situations and propose new strategies. Finally, you define yourself as a solution-oriented and methodical person who drives novelty.

**About Us**:
OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections.
The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.

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