Do you have a strong knowledge in Medical safety and are experienced in clinical Quality and more specifically in SOP writing and performing gap analysis? Do you want to share and extend your knowledge in a dynamic, growing Biotech company? Don't hesitate and apply now!
Job description
As a Medical Safety GCP Quality Lead you will be performing a procedural gap assessment and mitigation plan, including writing medical safety development SOPs.
Responsibilities:
Actively participate to the initial Gap Assessment phase (process mapping, process prioritization by criticality, SOP framework comparison and action plan definition) of the SOP harmonization initiativ
- Bring hands on medical safety expertise to the team effort specifically regarding regulations inputs
- Support process criticality definition
- Ensure proper mapping and comparison between mapped processes and SOP framework
- Ensure that identified gap remediation is articulated into a relevant action plan
Act as SOP technical writer and support medical safety partners in SOP writing and implementation
- Write the procedural documents based on the outcome of the gap assessment and action plan definition, and based on the input from the operational teams
- Coach the medical safety partners in the implementation and training of the revised and/or new procedures
- Coach the partners in SOP maintenance
Requirements:
- Education: Masters degree in a scientific discipline or equivalent by education and experience
- Experience: More than 10 years experience in the Pharmaceutical or Biotechnology industry with a minimum of 2 years in a Quality Management environment
- Current and strong knowledge of Clinical Development processes according to Good Clinical Practices (GCP) and regulatory requirements.
- Notions of other GxP requirements
- The ability to present complex issues in a way that is understandable cross functionally and at all levels of the organization
- Excellent problem solving and analytical skills, including knowledge of root cause analysis tools / methodologies.
- Strong interpersonal skills resulting in an effective (intra- and cross-departmental) team player.
- A strong personality, a high degree of flexibility, assertiveness and excellent communication skills are essential to success. In addition, well-developed problem solving, decision-making and analytical thinking skills are highly desirable.
- Good communication / interpersonal skills and diplomacy are essential to be successful in the Quality Management role.
- English proficient knowledge is required
- Existing right to work in Europe is required.
Benefits
- Fulltime position until the end of the year (freelance or employee)
- A balanced salary package based on your capabilities and experience, including extra legal benefits (employee)
Vacancy number: 24967
