Perspective Therapeutics

Senior Manager, GCP Quality Oversight

Remote
Full Time
Quality
Manager/Supervisor
Objective

The Senior Manager, GCP Quality Oversight is responsible for providing independent, risk-based oversight of GCP compliance across the clinical development organization for radiopharmaceutical programs. This role sits within the Quality organization and partners closely with Clinical Operations, Clinical Development, Regulatory Affairs, Data Management, and external vendors to ensure clinical trials are conducted in compliance with ICH-GCP, applicable global regulations, and company SOPs.

This individual does not execute clinical trials, but ensures the systems, processes, and behaviors supporting trial execution are compliant, inspection-ready, and fit for the unique operational and regulatory complexities of radiopharmaceutical development.

Essential Functions

GCP Oversight & Compliance
 
  • Provide independent GCP quality oversight of clinical trials across all phases, with a focus on radiopharmaceutical-specific risks (e.g., IMP handling, imaging endpoints, site capabilities).
  • Serve as the primary Quality partner to the Clinical organization, ensuring clear separation of execution and oversight.
  • Interpret and operationalize ICH-GCP (R2/R3), FDA, EMA, and other global regulatory requirements as they apply to radiopharmaceutical clinical development.
  • Identify, assess, and escalate GCP compliance risks using a risk-based quality management (RBQM) approach.

Inspection Readiness & Regulatory Support
 
  • Lead GCP inspection readiness activities for clinical programs, including:
    • Mock inspections
    • TMF readiness assessments
    • Process and system gap analyses
  • Support health authority inspections and sponsor audits, including preparation, conduct, response development, and CAPA oversight.
  • Partner with Regulatory Affairs during submissions to ensure clinical quality considerations are addressed.

Quality Systems & Processes
  • Oversee the application of Quality Management System (QMS) elements relevant to clinical trials, including:
    • SOPs and work instructions
    • Deviation and CAPA management
    • Change control impacting clinical processes
  • Review and approve clinical SOPs, vendor SOPs, and trial-level quality plans as appropriate.
  • Ensure quality by design principles are embedded into clinical trial planning and execution.

Vendor & CRO Oversight
  • Provide quality oversight of CROs, imaging vendors, central labs, and radiopharmaceutical suppliers involved in clinical trials.
  • Participate in vendor qualification, audits, and performance reviews from a GCP quality perspective.
  • Ensure vendor oversight models meet regulatory expectations for sponsor accountability.

Cross-Functional Partnership
  • Act as a trusted advisor to Clinical Operations and Clinical Development leadership on GCP and inspection-readiness matters.
  • Collaborate with Medical and operational Leadership, CMC/Technical Operations, and other stakeholders on cross-cutting quality risks.
  • Deliver targeted GCP training and coaching to clinical teams as needed.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience

  • Bachelor’s degree required; advanced degree (MS, PharmD, PhD, MD) preferred.
  • 8+ years of experience in GCP, Clinical Quality, QA, or Clinical Operations with demonstrated quality oversight responsibilities.
  • Hands-on experience supporting clinical trials in oncology and/or radiopharmaceuticals strongly preferred.
  • Deep working knowledge of:
  • ICH-GCP
  • FDA and EMA GCP regulations
  • Inspection readiness and audit management
  • Experience interacting with health authorities or supporting regulatory inspections.
  • Strong understanding of CRO and vendor oversight models.
 

Knowledge / Skill / Ability

Comfortable operating in ambiguity and building processes from scratch
  • Pragmatic, risk-based mindset (knows when to push and when to enable)
  • Strong influencer who can partner effectively without direct authority
  • Clear, concise communicator with good judgment
  • High integrity and independence consistent with a Quality role Willingness to travel up to 10%.

Work Environment


The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable   individuals with disabilities to perform the essential functions.
 
  • May be required to sit or stand for long periods of 8+ hours a day while performing duties. 
Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.
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