Clinical Quality Assurance Manager
Venn Life Sciences is an Integrated Drug Development Partner offering a unique combination of drug development expertise and clinical trial design and management. This enables us to create, plan and execute drug and medical device development programs effectively and seamlessly for our clients. We have dedicated operations in Ireland, France, Germany, the Netherlands, the UK, the US, and Europe-wide representation.
“Our vision is to deliver results of the highest quality to our global clients on time and within budget. We do this through developing our staff to be world class in their fields and forming real, lasting relationships with our clients.”
We are currently looking for a Clinical QA Manager with hands-on experience to join our team. The successful candidate will have the opportunity to work from one of our European offices (in Paris, Breda, Hoogeveen or Rheinbach) and/or home-working.
Reporting to the Head of Quality Assurance, the successful candidate will be responsible for ensuring the robustness and effectiveness of a specific part of the organization’s Quality Management System (QMS) governing the assigned area of regulated operations, across divisions, for Clinical or non-Clinical Research. The job also includes the execution of contracted QA services, such as audits on Venn projects or consultancy projects, as assigned.
If you are seeking a rewarding and challenging career this could be the perfect opportunity for you.
- Support the Head of QA in establishing a clearly defined QMS that is robust and effective in ensuring regulatory compliance.
- In collaboration with assigned operations departments, support the development of written procedures (SOPs) that ensure compliance with applicable regulatory requirements and industry standards.
- Investigate and report on deviations. Ensure effective root cause analysis is performed and adequate CAPA plans are defined and implemented in a timely manner.
- Identify process improvement opportunities and foster a culture of quality.
- Develop training materials and/or deliver training related to quality, as assigned, and in collaboration with the Training department.
- Provide guidance and support to project teams on the pragmatic interpretation of GxP, Procedural Documents (SOPs), quality and regulatory requirements.
- Help develop and maintain quality management related metrics to help the company understand how it is performing with respect to quality.
- Effectively manage the relevant part of the internal QA audit program in accordance with applicable procedures and utilizing a risk-based methodology.
- Plan and conduct programmed and contracted audits according to applicable procedures and/or client expectations. These may include:
- System, process and facility audits, and
- Study audits including Investigator site audits, and
- Vendor/Supplier audits, and
- Computerized system validation audits.
- Facilitate and host sponsor audits and regulatory authority inspections at Venn according to internal procedures.
- Liaise with client sponsor auditors and regulatory inspectors on the follow-up of findings and the implementation of agreed CAPA plans.
- Can be assigned as QA consultant on client QA projects depending on required technical expertise and experience
Qualifications & Experience:
- University (or comparable) degree in life sciences such as BSc or MSc.
- Minimum 8 years’ international clinical research experience in a pharmaceutical company, CRO or regulatory body or equivalent combination of education, training and experience. Ideally with a background in one of the following: Clinical Data Management, Biometrics, Pharmacokinetics, Pharmacometrics, and/or Medical Writing.
- Minimum of 4 years’ experience in Quality Management.
- Minimum of 2 years’ auditing experience in GCP.
- Experience conducting root cause analysis, review of effective CAPA plans and risk management principles.
- Excellent knowledge and understanding of ICH/GCP
- Excellent interpersonal skills with the ability to work diligently, accurately and under pressure, alone and/or as part of a team.
- Good analytical skills with the ability to evaluate data trends for lessons learned, required action.
- Ability to find effective solutions to deal with complex matters (e.g. resolving independently or with support of other (e.g. external parties)
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
- Demonstrated project management skills.
- Proficiency in PC skills (e.g. SharePoint, MS Office and Outlook).
- Prepared to travel locally and internationally up to 20% of time.
How to apply:
Please forward your CV (in English) by email to Liane Brown-Feaheny, email@example.com
PLEASE NOTE THAT DUE TO THE HIGH VOLUME OF APPLICATIONS WHICH WE RECEIVE WE WILL ONLY BE ABLE TO REPLY TO CANDIDATES WHOM WE ARE INVITING FOR INTERVIEW.
We do not require the services of agencies for this role.