The Opportunity
PHALANX8 is expanding its inspection-readiness and regulatory-response capabilities for life sciences organizations facing heightened scrutiny. The Senior Consultant (Former FDA) brings prior FDA field perspective to help clients prepare for inspections, respond with discipline during active agency engagement, and address compliance gaps through practical remediation.
This role sits where regulatory expectations meet operating reality. You will advise quality, regulatory, and operations leaders across pre-approval, routine surveillance, and for-cause situations, translating inspection signals into clear actions and defensible outcomes.
The opportunity combines client-facing advisory work, on-the-ground inspection support, and hands-on quality system improvement within a platform built for rigor, accountability, and sustained control.
Responsibilities
Inspection Readiness and Inspection Support
Lead inspection readiness assessments and mock inspections across GMP, GCP, GLP, and medical device quality system expectations. Support client teams through inspection preparation, inspection conduct, and response strategy, including executive coaching and issue triage under time pressure.
Compliance and Remediation
Assess quality system performance and identify gaps that drive regulatory exposure. Support remediation planning for Form 483 observations and Warning Letters, including root cause development, CAPA strategy, and evidence packages that demonstrate closure and control.
Regulatory Strategy and Risk Posture
Advise leadership on regulatory risk posture across lifecycle stages, from pre-approval through post-market. Interpret guidance, inspection trends, and enforcement patterns to help teams prioritize readiness investments and focus on the issues most likely to be tested.
Quality Systems and Sustained Control
Evaluate and strengthen SOPs, governance, data integrity controls, documentation practices, and manufacturing oversight. Help teams build mechanisms that prevent recurrence, improve oversight discipline, and reduce reliance on heroics during inspections.
Thought Leadership and Client Development
Support pursuits as a subject matter resource and contribute to market-facing perspectives on inspection readiness, enforcement response, and quality system performance. Represent PHALANX8 in industry settings where credibility and judgment matter.
You
You are a former FDA investigator or inspector with direct field inspection experience and the ability to translate inspection expectations into practical execution. You operate calmly in high-pressure situations and can coach executives and operational teams on inspection conduct, responses, and escalation choices.
You understand how quality system weaknesses become enterprise risks. You can connect regulatory language to root causes in operations, documentation, governance, and data integrity, then drive a remediation path that is complete, coherent, and usable when it matters.
You communicate with precision and maintain strict professional boundaries. You do not represent FDA, and you are transparent that your role is independent advisory support based on prior experience.
Compensation and Benefits
PHALANX8 offers a competitive compensation package that matches your role, experience, and impact. This includes base compensation and performance-based incentives tied to role contribution and client outcomes. Benefits include comprehensive health coverage, retirement plans, and flexibility appropriate for a client-facing senior role.
Your Leadership, Our Platform
PHALANX8 is building senior capability across regulatory strategy, quality, and compliance. The platform is designed for professionals who want to apply sound judgment in high-stakes moments, work alongside client leaders, and deliver outcomes that hold up under scrutiny.
If this role matches how you operate and what you want to build, apply now.
Equal Opportunity Employer
PHALANX8 is an Equal Opportunity Employer. We make employment decisions based on business needs, role requirements, and individual qualifications. We do not discriminate based on race, color, religion, creed, sex (including pregnancy, childbirth, or related conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, or any other status protected by applicable law.
PHALANX8 is committed to a workplace where respect and professionalism are expected, and where different perspectives strengthen how we think and deliver.
