We are always interested in hearing from experienced quality, compliance, and validation consultants. The work is project-based or interim, at pharmaceutical, biotech, and medical device companies and CDMOs.
If you have spent your career in GxP quality, compliance, or validation, we would like to hear from you. Our consultants work on projects and interim roles at pharma, biotech, device, and CDMO companies. Tell us what you have done and what you want to do next.
Before we talk to you about any opportunity, we want to know what you have actually done. Which systems you have validated, which inspections you have been through, and what kind of work you want next.
The first call is about you. Your experience, the sectors you have worked in, and how you like to work.
We never send your profile to a client until we have talked about the specific role and company and you have said yes.
We will only bring you roles that make sense for your background. If you have spent ten years validating SAP at pharma sites, we will not call you about a device design controls job.
You will always know where things stand. If we do not have anything that fits right now, we will say so, and we will call you when we do.
These are the kinds of contract roles we fill most often. What is open changes week to week, so get in touch to find out what is current.
Owns validation for SAP or Oracle at a pharma or biotech cGMP site. IQ/OQ/PQ, change control, and keeping the system ready for inspection.
Computer System Validation and Computer Software Assurance under GAMP 5, Part 11, Annex 11, and FDA's CSA guidance.
Runs the QMS at an FDA-regulated pharma or biotech company: CAPA, change control, document control, and deviations.
Internal audits, supplier audits, and mock inspections in GMP and GLP settings, with follow-up on the CAPAs that come out of them.
Quality system work under the QMSR and ISO 13485, including design controls, complaint handling, CAPA, and audit preparation.
SAP S/4HANA and SAP QM validation at pharma and biotech sites. IQ/OQ/PQ, audit trails and GRC, and upgrades under change control.
Runs validation programs, including ERP implementations, at pharma, biotech, and CDMO sites. Keeps QA and IT working from the same schedule and on track for regulatory dates.
Change control and remediation work at companies dealing with a Form 483, a warning letter, or an upcoming pre-approval inspection.
Contract consultants are paid through an employer of record. Our EOR partner handles payroll, tax withholding, and benefits. You work on-site or remotely with the client.
Engagements range from a short remediation project to a validation program that runs several years. We will talk through rate, structure, and timing with you before your name goes to any client.
Send us your background. When we have an engagement that fits, we will call you to go over the scope.