Csv Director
vor 2 Wochen
Hobson Prior are currently looking for a CSV Director to join a brilliant organisation on a permanent basis located in Bern with the ability to work remotely from home. Our client is focused on utilising their state-of-the-art manufacturing facilities meet global regulatory requirements and employ the latest disposable production technologies, allowing maximum flexibility and short turn-around times.
Please note that to be considered for this role you must have the right to work in this location.
**Key Responsibilities**:
- For this position, you will be guaranteeing program distribution of critical programs within the portfolio, organisational alignment on scope, schedule, quality, benefits, and execution, as well as supervise suitable controls to actively handle obstacles to finalisation by working with the GPO.
- To stay up to date of fluctuations in regulations that disturb obstructed processes as well as recognise innovative ways of operating and developing technologies in this area, you will contribute to and direct regulatory observation and benchmarking enterprises with external associates.
- To sustain such a program, you will support the development of a steady tactic and procedure for computer systems validation with the right roles and competences.
- You will direct cross-functional teams through indistinctness to a vibrant and actionable verdict.
- Uphold consciousness of Culture of Excellence across BMS.
- To guarantee general project success, you will classify and track progress against crucial project markers affiliating with pertinent business, quality and any other permitting functions and any external suppliers.
- Gather and document on CSV metrics using QRM principles - used by Quality Council network to supervise functionality.
- Analyse and trend towards suitable Quality Councils which involves the company's Tier 1 Quality Council.
- Any other assigned duties.
**Key Skills**:
- Proven revolution, flexibility, broad mindedness, and malleability to meet goals in a swiftly changing setting where priorities may fluctuate.
**Requirements**:
- Educated to a degree level in a science or health-related discipline.
- At least 10+ years of working experience within a pharmaceutical industry in specific specialities such as R&D, Operations, Validation, and/or Quality.
- Previous experience executing CSV international for operational purposes and national systems across GMP, GCP and/or GLP.
- Solid experience managing cross-functional programs with the capacity to handle multiple projects concurrently.
- Serve as a Subject Matter Expert in CSV, pertinent global regulations and direction.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.