The Opportunity
This role sits at the center of PHALANX8’s mission to deliver inspection-credible speed across life sciences. The Managing Director, FDA Compliance & Inspection Readiness, will build, lead, and scale a flagship capability focused on regulatory trust, inspection performance, and sustained quality integrity.
You will shape how organizations prepare for, experience, and emerge from regulatory scrutiny. This includes defining the firm’s approach to inspection readiness, remediation, and quality transformation while serving as a senior advisor in the moments that matter most: FDA inspections, enforcement actions, and enterprise-wide compliance inflection points.
The opportunity combines practice leadership, executive advisory work, and commercial ownership. It is a role for a leader who can translate regulatory rigor into decisive action, align teams under pressure, and grow a business without compromising standards.
Responsibilities
You will set the strategic direction for PHALANX8’s FDA Compliance & Inspection Readiness practice, building scalable offerings across inspection readiness, remediation, quality transformation, and regulatory intelligence. This includes establishing delivery methodologies, tools, and quality standards that withstand regulatory scrutiny and client expectations alike.
On the client front, you will act as executive sponsor and senior advisor on complex engagements, including FDA inspections and PAIs, 483 and Warning Letter remediation, consent decree support, and global quality system remediation. You will engage directly with executive leadership and, when required, boards, providing clear judgment where guidance is incomplete and stakes are high.
You will own revenue growth for the practice, originating and closing new engagements, building long-term executive relationships, and partnering across PHALANX8 practices to drive integrated solutions.
As a people leader, you will recruit, develop, and retain senior talent, build a strong leadership bench, and mentor Directors, Principals, and future successors. You will also represent the firm externally through thought leadership, conference participation, and ongoing translation of regulatory trends into practical, defensible service offerings.
You
You bring 15–20+ years of experience operating in FDA-regulated environments, with deep exposure to quality, compliance, regulatory, and manufacturing contexts. You have led or supported multiple FDA inspections and understand both the letter of the law and the lived reality of regulatory expectations.
You combine technical depth in FDA regulations, GxP, QMS, inspection readiness, and remediation with executive presence and commercial judgment. You are comfortable advising C-suite leaders, making defensible calls under pressure, and standing behind decisions when scrutiny intensifies.
You likely hold a bachelor’s degree in life sciences, engineering, or a related discipline, with an advanced degree preferred. Prior consulting leadership experience is strongly valued, but what matters most is credibility, judgment, and the ability to lead complex work without noise or drama.
You operate with calm authority, evidence-first thinking, and a bias toward closure. You build trust by being precise, direct, and accountable, especially when outcomes matter more than explanations.
Compensation and Benefits
PHALANX8 offers competitive executive-level compensation aligned to responsibility, impact, and performance. This includes a base salary, performance-based incentives tied to practice growth and delivery outcomes, and participation in broader firm success.
Beyond compensation, the firm offers a leadership environment defined by clarity, autonomy, and professional respect. You will have the latitude to build a practice the right way, work alongside experienced peers, and operate in a culture that values judgment, integrity, and sustained excellence over volume or theatrics.
Your Leadership, Our Platform
PHALANX8 is building senior capability across regulatory strategy, quality, and compliance. The platform is designed for leaders who want to shape scalable offerings, advise executives in high-stakes moments, and build teams that deliver work with rigor and consistency.
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 on the basis of 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.
