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A biotech company in Spain is seeking a Senior Clinical Quality / QMS Consultant to build and implement a clinical Quality Management System (QMS) from the ground up. The organization currently lacks a formal clinical QMS and SOP framework, and needs a scalable, compliant infrastructure to support ongoing and future programs across vaccines, oncology, and other therapeutic areas.
The consultant will play a critical role in supporting a late-stage clinical program as it approaches interim analysis and eventual regulatory submission. This role will focus on establishing a strong clinical quality foundation, ensuring audit readiness, and unifying clinical and safety data across studies and phases.
Responsibilities
- Design and implement a clinical QMS framework aligned with GCP and GVP requirements
- Develop and standardize clinical SOPs, policies, and procedures
- Create and maintain audit-ready documentation and quality systems
- Ensure traceability and integrity of clinical and safety data across studies and phases
- Support regulatory submission readiness and inspection preparedness
- Consolidate and harmonize clinical and pharmacovigilance data from multiple programs
- Collaborate with external partners and oversee quality in an outsourced CRO model
- Implement and optimize Veeva-based systems and workflows
- Train and upskill internal teams to ensure long-term QMS sustainability
- Establish scalable processes to support future clinical programs
Qualifications
- Deep experience in clinical QMS development and implementation, including building systems from scratch
- Industry background in biotech and/or pharmaceutical companies (required)
- Hands-on experience with Veeva (required); Veeva certification is a plus
- Strong expertise in GCP and GVP regulations
- Proven experience in:
- SOP development
- Audit and inspection readiness
- Regulatory submission support
- Clinical and safety data traceability
- Experience consolidating clinical safety data across multiple studies/phases
- Experience working within outsourced CRO environments
- Strong preference for vaccine experience; oncology experience highly valued; broader therapeutics exposure is a plus
Start: ASAP
Duration: ~4 months, with potential extension
Time commitment: 5 days per week
Location: Hybrid, with visits to client site in Spain once a month for 1-2 weeks
Project ID#: 8726
*This is a contract role that does not offer health benefits
