Senior Clinical Quality Assurance Specialist
This position is working towards implementing Clinical QA oversight, integrating Clinical operations into their Quality system. The Clinical QA Manager is providing GCP consultancy to stakeholders. The role of this position also includes management and performance of QA audits of clinical trials including but not limited to investigator site audits, audits of vendors, internal Operational audits in order to assure compliance with SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and EN ISO 14155 requirements.
Our Client is an innovative R&D Biotech that has many agents at various trial phases and successfully achieved FDA Approval in 2015 for a new medical device within Oncology. They have a start up feel about them which creates a fast-paced, highly dynamic and entrepreneurial culture with an emphasis on being patient centric. They went “live” in 2015, so they are still setting and building up the structures and processes and are now in a role out phase for their new product. They are looking for a Senior Clinical Quality Assurance Specialist for a permanent position to be based in the Lucerne area.
The ideal candidate should have 7 years of previous experience with Clinical Quality Assurance in a Pharmaceutical environment, preferable in a Medical Device.
- Effectively plan and perform regular and random QA audits of clinical trials including but not limited to investigator site audits, audits of vendors, internal Operational audits in order to assure compliance with all SOPs, study protocols, ICH GCP guidelines, relevant regulations and EN ISO 14155 requirements;
- Manage and maintain databases for the quality system;
- Become involved, when required, in project audit management and staff training and contribute to the review of company systems and procedures as appropriate;
- Have a thorough knowledge of all relevant SOPs, ISO requirements and appropriate regulations and guidelines;
- Develops the company’s Quality Management System – focusing on implementing Clinical operations into QMS;
- Evaluate/Manage quality issues, CAPAs, and complaints;
- Participate in Inspection Readiness activities including hosting of Regulatory inspections and external audits;
- Ensure that audit results are formally recorded and reported and that corrective/preventive actions are properly completed and documented;
- Assist with the development of project audit procedures.
Qualifications and Experience:
- Degree in Medicine, Technical/Scientific Studies, or equivalent;
- 7 plus years of Clinical Quality Assurance experience in a Pharmaceutical, preferable in a Medical Device regulated environment;
- Proven Auditing experience;
- Experience with regulatory inspections;
- Knowledge of regulations for Medical Devices, especially EN ISO 14155, ICH-GCP;
- Fluent English is a must-have, German is an asset;
- Able to work independently;
- Willing to work in an international environment;
- Excellent written and oral communications;
- Analytical skills;
- Consistently displays a positive, patient attitude and extends respect and courtesy toward Supervisors and peers alike;
- Leading by example and motivating others;
- Highly organized and detail-oriented;
- Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities.
- Ability to work independently with minimal supervision and as a member of a team;
- Enthusiasm, attention to detail, the ability to meet aggressive deadlines, and ability to work effectively with others in a fast paced, highly-productive environment;
- Having integrity and a strong work ethic;
- Results and goals oriented;
- Willingness to travel at least 40% of time (international and domestic);
- Relevant working/residency permit or Swiss/EU-Citizenship required.