Supplier and CDMO audits led personally by Roberto L. Rivera — 45 years of cGMP experience, former Pfizer Senior Audit Manager. Independent qualification and surveillance audits across global supply chains — whether you're qualifying a new vendor or extending an audit schedule your team can't cover alone.
When the FDA inspects you, your suppliers' failures become your findings. An unqualified API source, an excipient vendor with a weak quality system, a CDMO cutting corners on the floor — each one is a gap in your own compliance posture, whether or not your team has the capacity to see it.
Meanwhile, the audit schedule keeps growing. New suppliers to qualify, approved ones due for surveillance, for-cause audits that jump the queue — and an internal team that can only be in one place at a time. Audits slip, and unqualified risk accumulates quietly in the supply chain.
An experienced independent auditor closes both gaps: qualifying vendors rigorously, and giving your program the capacity to stay on schedule.
"We're short of auditing resources to meet our supplier, contractor, and facility audit goals. I need someone who has done it all to help us stay on schedule."
This is one of the most common reasons clients call. Roberto audits as an independent Lead Auditor on your behalf — using your program or his — so the schedule gets met and the qualifications hold up under inspection.
From a single for-cause audit to a full outsourced audit program. Roberto is your Lead Auditor, not a project manager.
Qualification and requalification of active ingredient, excipient, and raw-material suppliers against ICH Q7, 21 CFR 211, and applicable regional standards.
Full qualification of contract development and manufacturing organizations, including complex biologics and sterile operations, domestic and international.
GMP and ISO/IEC 17025 assessment of contract testing labs — analytical chemistry, microbiology, and specialized methods.
Scheduled requalification that keeps approved suppliers in a qualified state and your program continuously inspection-ready.
Independent Lead Auditor capacity to meet your annual supplier, contractor, and facility audit schedule when your internal team is stretched.
Design of vendor approval programs, technical requirements, qualification criteria, and audit checklists — built at Pfizer and Wyeth scale.
Roberto reviews the supplier, the materials or services involved, and your qualification requirements, then builds a targeted audit plan and agenda. A mutual NDA can be executed first.
The audit is conducted against your program or his — systems, facilities, documentation, and the floor — with real-time observations and a daily debrief so there are no surprises.
A written report with prioritized findings mapped to the applicable regulations, plus a clear qualification recommendation your quality system can act on.
Review and approval of the supplier's corrective action responses, confirming the gaps are genuinely closed before qualification is granted.
A requalification cadence is set so approved suppliers stay qualified and your audit program stays ahead of the schedule rather than behind it.
You work directly with Roberto L. Rivera — not a rotating team of junior associates. A former Pfizer Senior Audit Manager who led the Manufacturing and Supplier Quality Assessments Group across biotech, pharmaceutical, nutritional, medical device, consumer healthcare, and veterinary suppliers on five continents. Bilingual in English and Spanish, with deep experience qualifying complex biologics and CDMOs internationally.
API manufacturers, excipient and raw-material suppliers, CMOs and CDMOs, contract laboratories, packaging and component suppliers, and specialized biologics and sterile manufacturers. Roberto has audited across all of these categories on five continents.
Yes. Many clients engage Roberto specifically to meet a supplier, contractor, and facility audit schedule their internal team cannot cover alone. He performs audits as an independent Lead Auditor on your behalf — using your program and templates or his — and delivers findings your quality system can act on directly.
Yes. Roberto has performed supplier and CMO qualification audits across the US, Canada, Europe, Asia, and Latin America, and is bilingual in English and Spanish — especially experienced with complex biologics and CDMO qualification across international supply chains.
A written audit report with prioritized findings mapped to the applicable regulations, a clear qualification recommendation, and review and approval of the supplier's CAPA responses. Ongoing surveillance audits can be scheduled to keep approved suppliers qualified.