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Staff Augmentation
Senior QA, QC, and RA consultants who integrate directly with your team.
Add senior quality and regulatory capacity exactly when you need it.
Quality Confidential is a women-owned GxP consulting firm that helps pharmaceutical, biopharmaceutical, biotech, medical device, gene therapy, IVD, diagnostics, and cosmetic companies add senior quality and regulatory capacity exactly when they need it.
Our rigorously vetted global network of 200+ senior to executive-level QA, QC, and RA consultants integrates directly with client teams, from short-term project support and on-site Person-in-Plant oversight to long-term embedded roles. Each consultant is selected for technical depth, regional and regulatory alignment, and cultural fit with your organization.
Senior to executive-level QA, QC, and RA consultants in our global network
Women-Owned · Certified Diverse Supplier · Senior QA, QC & RA Talent
Staff Augmentation Services
From project-based QMS support to on-site Person-in-Plant oversight and CQV program leadership, our consultants handle the work that keeps quality moving: batch record review and disposition, investigations, complaints, health hazard analysis, and document control. Core engagement types include:
Project-Based QMS Support
Person-in-Plant (PIP) On-Site Oversight
Interim Quality Leadership & Business Continuity
Remediation Support & Role Back-Fill
Capital Project & Validation Program Leadership
Pharma & Biologics Program Leadership
Senior leaders who own the validation and quality programs behind capital projects, facility start-ups, expansions, and technology transfer, across API, biologics, gene therapy, and fill/finish manufacturing. They lead multidisciplinary teams of engineers, contractors, and SMEs, and report progress, KPIs, and risk directly to client leadership.
CQV Leadership
- Commissioning & Validation Master Plans
- FAT/SAT and IQ/OQ/PQ execution
- Facility, utility & equipment qualification
- W1/W2 walkdowns and punch list closure
- Vendor package review
- Critical path and schedule risk recovery
- Greenfield and expansion program leadership
Process Validation & PPQ
- Process Validation Master Plans
- PPQ master protocols & summary reports
- Statistical analysis plans
- Technology transfer and engineering runs
- Process characterization studies
- Cleaning, shipping & hold-time programs
- BLA/NDA Module 2/3 submission support
Quality Engineering
- Investigations, root cause analysis & CAPA
- Deviation management and change control
- Quality risk assessment (FMEA/pFMEA)
- Quality system remediation
- Facility readiness & product transfer quality
- SOPs, protocols & technical reports
- Audit and inspection readiness
Standards and systems. Programs run to ASTM E2500, ICH Q8/Q9/Q10, Annex 15, and ISPE guidance under risk-based (QRM) approaches, built inside client e-validation platforms such as Kneat, MasterControl, and TrackWise, with schedules managed in Primavera P6 or MS Project and analysis in JMP or Minitab.
Medical Device Program Leadership
The same leadership bench for device manufacturing: commissioning, qualification, and process validation for production start-ups, line transfers, and expansions. Our leads work across Design Engineering, Manufacturing Engineering, Automation, Quality, and Regulatory to carry deliverables through approval, execution, and closure.
CQV Leadership
- Commissioning & Qualification Master Plans
- IQ/OQ/PQ protocols and execution
- Automated assembly & inspection systems
- Test equipment qualification
- Cleanroom facility and utility qualification
- FAT/SAT and punch list closure
- Line transfers, start-ups & expansions
Process Validation
- Process Validation Master Plans & reports
- Molding, sterilization, packaging & sealing
- Automated assembly process validation
- Design Transfer from R&D to commercial
- DHF and DMR documentation support
- Gauge R&R and process capability studies
- 510(k)/PMA-supporting documentation
Quality Engineering
- Investigations, root cause analysis & CAPA
- Nonconformance & change control
- Design Controls support
- Risk management to ISO 14971
- Statistical process control (SPC)
- Quality system remediation & line readiness
- FDA and Notified Body inspection readiness
Standards and systems. Programs run to FDA 21 CFR 820 Quality System Regulation, ISO 13485, and ISO 14971 risk management, with statistical analysis in Minitab or JMP and schedules managed in MS Project or Primavera P6.
Flexible Engagement, Global Reach
Consultants sourced regionally and globally to align with your site, time zone, and regulatory context
On-site, hybrid, or fully remote support, structured around how your team actually works
Scale capacity up or down to match program demand, without adding permanent headcount
Experience across FDA, EMA, PMDA, and ISO frameworks in pharmaceutical, biopharmaceutical, biotech, medical device, gene therapy, IVD, diagnostics, and cosmetic organizations
Consultant Qualifications
Consultants are matched to each engagement based on education, certification, industry experience, knowledge of applicable regulations, and regional and language requirements. Levels range from Senior Compliance Consultants for focused project support to Principal Consultants and former regulatory authority investigators for leadership roles.
Former FDA and regulatory authority investigators
ASQ CQA and ISO 13485 certified lead auditors
Specialized subject matter experts across GxP disciplines
Women-Owned Business
Quality Confidential is a women-owned GxP consulting firm and a certified diverse supplier. Our global network of 200+ senior to executive-level QA, QC, and RA consultants supports pharmaceutical, biopharmaceutical, biotech, medical device, gene therapy, IVD, diagnostics, and cosmetic organizations.
Why Quality Confidential
Confidential by design
No client logos, no case studies. Every engagement is a protected relationship.
Senior-level only
Every engagement is led by senior professionals with decades of real-world industry and regulatory experience.
Integrity above profit
We recommend only what serves patients and your long-term compliance.
Have a role to cover?
Tell us what you need covered and we will match you with the right consultant, in complete confidence.
Request a Confidential Consultationinfo@qualityconfidential.com | 919-622-5826