Vacancy Clinical QA Manager – Breda
The organisation is a drug development partner, offering an innovative combination of drug development knowledge, clinical trial design and management and is currently looking for a Clinical QA Manager. This allows them to create, plan and execute drug and medical tech development programs effectively and seamlessly for their client portfolio. Currently they have operations throughout Europe, in countries such as France, Germany, Ireland and facilities in the UK and US.
The company’s mission is to play a pivotal role in the development of new products that allows disease prevention and treatment. They do this by creating an environment where you as a professional can develop yourself and expertise your valued talents. This organisation nurtures a place where respect, pro activity, teamwork and last but not least, keep the patient at the heart of what we do. Due to growth of the company they are now looking for a Clinical QA Manager who wants to join the team in their Breda’s office.
- 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 utilising 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 Computerised 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
The ideal candidate meets the following requirements:
- Excellent knowledge and understanding of GCP
- Excellent interpersonal skills with the ability to work diligently, accurately and under pressure, alone and/or as part of a team
- Minimum 2 years experience in a QA Clinical position phase 1
- Good command of the Dutch and English language in word and writing
The basis for your employment conditions is based on your work experience and knowledge.
- Salary indication approx. €70,000 – €85,000 based on experience
- Career and training opportunities
- Good secondary employment conditions package
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Associate | Biotech/Pharma division
+31 6 58 81 46 32
+31 23 754 86 60