🔍 Case Study: Precision Hiring for Regulatory Compliance in Life Sciences

Client Industry: Life Science (Contract Research Organization – CRO)

Role: GLP & GMP Quality Assurance Auditors (2 Placements)

Location: UK (Remote)

Timeframe: 6 weeks

The Challenge

A UK-based CRO faced urgent staffing gaps after winning a major tender and struggling to fulfill audit schedules for global pharmaceutical clients. Despite partnering with another agency, they failed to secure candidates who met the non-negotiable regulatory expertise:

• GMP Auditors: Required experience with EU Annex 1 (sterile manufacturing), MHRA/FDA inspections, and audit leadership in pharmaceutical production.

• GLP Auditors: Needed proficiency in OECD principles, preclinical study audits, and familiarity with UKAS/EMA standards.

Existing candidates lacked hands-on experience with lead auditor responsibilities and cross-border regulatory frameworks, forcing the client to rely on costly third-party auditors.

Our Approach

Qualitas deployed a data-driven, compliance-focused strategy:

1. Audit Matrix Development:

   • Collaborated with the client to define “must-have” vs. “trainable” skills. Critical requirements included:

     • Minimum 3+ years leading GLP/GMP audits.

     • Experience with ≥2 regulatory agencies (e.g., FDA, EMA, MHRA).

     • Proven track record in audit documentation and CAPA management.

   • Created a proprietary Audit Experience Matrix to quantify candidates’ expertise across:

     • Audit Types: Supplier, process, data integrity, facility.

     • Regions: EU, US, APAC.

     • Systems: SAP QM, TrackWise, Veeva.

2. Hyper-Targeted Sourcing:

   • Mined niche platforms (e.g., RAPS, ASQ networks) and LinkedIn for auditors with CRO/biopharma backgrounds.

   • Prioritised passive candidates open to remote roles but overlooked by generalist agencies.

3. Rigorous Screening:

   • Conducted 12 structured interviews, focusing on real-world audit scenarios (e.g., handling FDA 483 observations).

   • Submitted 4 pre-vetted GMP candidates and 3 GLP candidates, each mapped to the matrix.

4. Candidate Advocacy:

   • Prepared candidates for client interviews with insights into the CRO’s compliance priorities.

   • Facilitated feedback loops to streamline hiring manager decisions.

The Result

• Placements: Secured 2 auditors within 6 weeks:

  • GMP Auditor: 8 years’ experience, including MHRA-led sterile facility audits.

  • GLP Auditor: Former UKAS assessor with 20+ preclinical study audits.

• Impact:

  • Cost Savings: Eliminated £15k/month in external auditor fees.

  • Client Growth: Enabled the CRO to fulfill 100% of its Q3 audit schedule, securing repeat business from the tender client.

Ready to Solve Your Toughest Compliance Hiring Challenges?

Qualitas specialises in precision recruitment for life sciences. Let us turn your regulatory talent gaps into competitive advantages.

Contact us today to build teams that pass the audit test.