Clinical Development Quality Management Lead
Jocelyn Blackham is recruiting for a Clinical Development Quality Management Lead join an innovative biopharmaceutical company at their site based in Lausanne on a contract basis for 6 months. This role can be offered on a 60 – 100% basis. This rolecan be offered fully remote, with the occasional visit to site required.
The main purpose of the role will be to:
- Develop a “risk-based” compound-specific compliance program contributing to document / data accuracy, resulting in “dossier acceptability” by respective out-licensing partners (emphasis on eCTD Module 5)
- Contribute to CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process to establish a pro-active quality approach, guaranteeing compliance with regulatory requirements
- Provide compliance support and contribute to “in process / ongoing” oversight through evaluation & follow-up on reported quality events
Further responsibilities will include:
- Applying the risk-based approach, identify the need to & conduct co-auditing activities / quality visits with DPI and / or CRO representatives
- Creating KQI to identify areas for improvement based on risk-based compliance activities and audit observations
- Ensure proper DPI set-up & oversight of outsourced CRO activities, with primary focus on critical data points (primary endpoints) and critical processes
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- University Degree in Sciences or relevant academic background
- Previous experience in Quality Management in the pharmaceutical industry, including at least 3 years within Clinical Quality Management System & Compliance
- Excellent knowledge of GCP. Current and strong working knowledge of GCP, CFR Title 21 and regulatory guidance’s including, ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 compliance
This is an excellent opportunity to join an exciting biopharmaceutical company.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 51919 in all correspondence.
