GCP QA SME

GCP QA Subject Matter Expert (Contractor)

Workload: 60% – 100% Duration: 6 months

We are seeking a highly experienced GCP QA Subject Matter Expert to support a leading Biopharma client during a period of rapid clinical portfolio expansion and integration activities. This is a high‑impact, hands‑on role requiring a technical expert to ensure the highest standards of compliance, participant safety, and data integrity.

The successful candidate will act as an extension of the GCP QA Lead, managing a high volume of procedural deviations and audit oversight with total autonomy.

• Deviation Oversight: Conduct technical reviews and oversight of procedural deviations. Critically assess impacts on Good Clinical Practice (GCP) compliance, study data reliability, and the safety/rights/well‑being of trial participants.
• Audit Lifecycle Management: Lead the oversight of GCP audits, including the critical review of audit agendas and reports. Conduct professional debrief meetings with external consultants.
• CAPA Strategy: Drive the closure of Corrective and Preventive Actions (CAPAs). Partner directly with action owners to ensure remediation is robust, timely, and addresses root causes.
• Systems Management: Utilize Veeva Vault as the primary platform for documenting and managing the deviation and audit life cycles.
• Strategic Backup: Provide high‑level support and coverage for the QA Lead, ensuring continuity of quality operations during peak workloads or absences.

• Education: University degree in Life Sciences (e.g., Biology, Chemistry, Pharmacy, or related field) is required.
• Industry
  
  Experience:
  
  Proven track record working within the Pharmaceutical or Biopharma industry
  . Experience in a Sponsor environment is highly preferred.
• Clinical Foundation: Experience in Clinical processes in a QA setting.
• Veeva Proficiency: Hands‑on experience with Veeva Vault ecosystem for managing deviations and audits.
• Immediate Autonomy: This role is for an established expert. We are not seeking candidates requiring training or clinical candidates looking to transition into QA.
• Language
  
  Skills:
  
  Fluency in English is mandatory. Proficiency in German, Italian, or French is a significant advantage.