Beschreibung
Quality Site Manager
Randstad Professionals is looking for a Senior Quality Site Manager for our client in Basel. This role is 80% wherein you will be 2 days in Basel & 2 days in Berne. This is a 12 months contract and the candidate should be able to travel 25% of the time within Europe.
Key Areas and responsibilities:
- Single point of contact (SPoC) for Quality and Compliance Issues between CMO and the client
- Negotiate and maintain Quality Agreements between the client and CMO
- Maintain inspection & Audit readiness
- Participate in CMO regulatory inspections and the client Compliance audits, if needed
- Support site selection activities
- Lead GMP Commissioning efforts in line with the CMO life cycle
- Technical transfers/Quality Lead
- Manage CMO with regard to compliance and product quality
- Participate in Decommissioning efforts
- Represent Quality in Governance Committee meetings
- Support product complaint investigations
- Perform quality risk assessments, develop mitigation plan and follow-up on implementation
- Lead quality/process improvements with the CMO
- Ensure timely follow-up on CAPA at the CMO
- Monitor and report quality performance of the CMO
- Quality support of new development and design projects as applicable
- Provide on-site support during production and issue resolution by fostering effective interdepartmental and cross functional partnership
- Communicate new and updated regulatory and applicable client Standards to CMO, evaluate systems in place
- Escalate gaps of audit responsiveness, CAPA implementation, deviation reporting and management, investigation closure, HSE issues and change implementation with regard to quality and time
- Review of quality and compliance related documents such as but not limited to Master Batch Records, Deviation Reports
- Initiate/approve analytical transfer protocols/reports, process validation protocol/reports and change requests
- Create, review and evaluate CMO-related sections of the APR/PQR coordinate stability studies and sampling plans for release/stability with external and internal partners
- Coordinate and facilitate CMC variations and dossier updates as applicable between the client's technical regulatory and CMO
- Coordinate and manage CMO related changes
- Provide input to personal performance goals and departmental objectives
- The incumbent is responsible for personal training and continuing professional development.
Required Skills:
- Minimum BS degree. MS, PhD in chemistry, biology, pharmacy, engineering or other life science preferred.
- Experience in execution of quality operations and processes in the pharmaceutical industry required
- Experience in drug product manufacturing is preferred
- Strong analytical and creative problem solving skills to address a broad range of complex problems to support quality decisions; track record of problem solving in product quality
- Strong quality orientation with knowledge of cGMPs (FDA; EMA, Swiss Medic, Anvisa, JP)
- Regulatory guidelines and validation practices; track record of successful regulatory inspection preparation
- Effective communicator at all levels; excellent written, oral and interpersonal communication and presentation skills (English must, German or French beneficial)
- Ability to travel ca. 25% of the time, mainly in Europe
Good to know you!
Please note that only candidates who are a close match will be contacted regarding this role; non EU/EFTA Citizens cannot be considered.