The Opportunity
PHALANX8 is building a dedicated Complaints, CAPA, and Remediation capability to support life sciences organizations facing elevated quality risk, enforcement pressure, and systemic remediation challenges. The Managing Director, Complaints, CAPA & Remediation will lead and scale this capability, helping clients stabilize quality systems, reduce regulatory exposure, and restore confidence in product and patient safety.
This role sits where quality failures become enterprise issues. You will shape how organizations investigate, remediate, and prevent recurrence at scale, while building a practice that delivers disciplined, defensible outcomes under regulatory scrutiny. The opportunity combines practice leadership, executive advisory work, and commercial ownership within a growing Quality & Compliance platform.
Responsibilities
Practice Strategy and Capability Development
Define and execute the strategic vision for Complaints, CAPA, and Remediation services. Build scalable offerings across complaint handling system design and optimization, CAPA program remediation and effectiveness, investigation excellence and root cause analysis, and enterprise remediation and quality transformation. Establish methodologies, tools, templates, and best practices that drive consistent, high-quality delivery.
Executive Client Advisory and Delivery Excellence
Serve as executive sponsor and senior advisor on complex, high-risk engagements. Lead client situations including FDA Form 483 and Warning Letter remediation tied to complaints and CAPA, consent decree and corporate integrity agreement support, and large-scale investigation backlogs and systemic remediation efforts. Provide expert interpretation of FDA and global regulatory expectations and advise executive teams on risk-based prioritization, sequencing, and resource deployment.
Business Development and Growth
Own revenue targets for the Complaints, CAPA, and Remediation portfolio. Originate, shape, and close new consulting opportunities. Build long-term relationships with senior quality, regulatory, and operations leaders. Partner with other practices to deliver integrated, cross-functional solutions.
People and Leadership
Recruit, develop, and retain top-tier quality and compliance consultants. Build leadership depth and succession across Directors, Principals, and senior team members. Provide mentorship that reinforces sound judgment, investigation discipline, and follow-through.
Thought Leadership and Market Presence
Establish the firm as a recognized leader in complaints, CAPA, and remediation. Publish thought leadership, speak at industry conferences, and monitor enforcement trends and emerging regulatory expectations. Translate these insights into new service offerings and perspectives.
You
You are a senior quality and compliance leader with deep experience operating in FDA-regulated life sciences environments. You have led large-scale complaints, CAPA, and remediation programs and understand how quality system breakdowns translate into regulatory risk and business disruption.
You bring strong technical depth in complaint handling, investigations, CAPA effectiveness, quality risk management, and QMS design, paired with executive presence and consulting judgment. You are comfortable advising senior leadership during enforcement actions, inspections, and enterprise remediation efforts, and you can translate complexity into clear, defensible decisions.
You have a proven track record in consulting or complex operating environments, are commercially effective, and can influence at the C-suite and board level with credibility and precision.
Compensation and Benefits
PHALANX8 offers a competitive executive compensation package aligned to role scope, experience, and impact. This includes base compensation and performance-based incentives tied to practice growth and client outcomes. Benefits include comprehensive health coverage, retirement plans, and flexibility appropriate for a senior leadership role.
The firm provides a professional environment where leaders have the autonomy to build capabilities the right way, contribute to firm-wide growth, and operate within a culture that values rigor, accountability, and sustained quality performance.
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.
