RX2 Solutions ยท 3 weeks ago
Quality Site Head
Apex, NC
Full-time
Onsite
Director/Executive
10+ years expRX2 Solutions is launching a new FDA-registered 503B outsourcing facility in Apex, North Carolina, and they are seeking a Quality Site Head. This role involves leading all site quality functions, ensuring regulatory compliance, and maintaining inspection readiness while fostering a culture of accountability and quality within the organization.
ConsultingRecruitingStaffing Agency
Responsibilities
Lead FDA and Board of Pharmacy inspections and maintain continuous inspection readiness
Communicate clearly and confidently with regulators, grounded in strong 503B knowledge
Own SOP governance in MasterControl, ensuring procedures align with daily operations
Partner with Compliance Insight while retaining internal ownership of quality decisions
Lead all site quality functions including QA, QC, Microbiology, Validation, Environmental Monitoring, Calibration, and Document Control
Direct investigations, CAPAs, OOS/OOTs, change control, batch release, and risk assessments with sound scientific judgment
Provide quality oversight for lab build-out, equipment placement, and GMP workflow design
Partner cross-functionally to embed quality-first decisions into site operations
Own site training programs and MasterControl tracking for competency and compliance
Ensure all employees remain qualified with no gaps impacting quality or patient safety
Serve as the on-site extension of the Head of Quality with credibility and clarity
Build a culture of accountability, practical problem solving, and consistent execution
Qualification
Required
Bachelor's degree in Chemistry preferred. Biology or related scientific disciplines are considered
Ten plus years of Quality leadership in pharmaceutical manufacturing with strong sterile or aseptic experience
Proven ability to lead regulatory inspections and maintain inspection readiness
Deep understanding of 503B outsourcing facility requirements and modern GMP expectations
Experience managing external consultants while ensuring internal ownership of all quality decisions
Preferred
Advanced scientific degree
Experience supporting lab setup, equipment qualification, and workflow development
Background in growth-stage or rapidly scaling pharmaceutical operations
Company
RX2 Solutions
RX2 Solutions is a consulting firm that offers customized staff augmentation and talent acquisition solutions.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Robert Graham
Managing Partner & Co-Founder
Ross Rosner
Managing Partner & Co-Founder
Company data provided by crunchbase