Clinical Quality Assurance Specialist
This position is responsible for performing QA audits of clinical trials including but not limited to investigator site audits, audits of their vendors, internal operational audits in order to assure compliance with the company’s SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and EN ISO 14155 requirement.
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 Clinical Quality Assurance Specialist for a permanent position to be based in the Lucerne area.
The ideal candidate should have 5 years of previous experience with Clinical Quality Assurance in a Pharmaceutical, preferable, but not limited to a Medical Device regulated environment.
- Perform QA audits of clinical trials including but not limited to investigator site audits, audits of their vendors, internal Operational audits in order to assure compliance with the company’s SOPs, study protocols, GCP guidelines, relevant regulations and ISO 14155 requirements;
- Become involved (depending on experience), when required, in project audit management and staff training and contribute to the review of their systems and procedures as appropriate;
- Have a thorough knowledge of all relevant SOPs, ISO requirements and appropriate regulations and guidelines;
- Effectively plan and conduct regular and random QA audits (internal and external) in order to assure that clinical studies sponsored by the company is of the highest standard and is in compliance with the requirements of all SOPs, study protocols, relevant regulations and guidelines and with ISO 14155 requirements;
- Perform quality system audits as required.
- 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 for audits that are related to clinical operations (internal audits, Investigator site audits, clinical vendors etc.);
- Assist in training of staff regarding GCP, ISO 14155, MEDDEV, CFR, role of QA, regulatory inspections etc;
- Conduct induction/orientation of new staff in quality policies and procedures;
- Assist with the co-ordination of Regulatory inspections and assist at such audits as necessary;
- Carry out a consultant role for the global Clinical QA department, including project support, SOP preparation and review, implementing CAPA;
- Keep the line manager informed of any QA issues within the department that require attention.
Qualifications and Experience:
- Degree in Medicine, Technical/Scientific Studies, or equivalent;
- 5 plus years of Clinical Quality Assurance experience in a Pharmaceutical, preferable in a Medical Device regulated environment;
- Proven Auditing experience;
- 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;
- Consistently displays a positive, patient attitude and extends respect and courtesy toward Supervisors and peers alike;
- Highly organized and detail-oriented;
- Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities;
- 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.