GCP QA Subject Matter Expert (Contractor) Role Overview 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.

Core Responsibilities

• 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 lifecycles.
• Strategic Backup: Provide high-level support and coverage for the QA Lead, ensuring continuity of quality operations during peak workloads or absences.

Candidate Profile & Qualifications

• 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.