Director, GxP Quality Assurance

Director, GxP Quality Assurance New Jersey, United States (San Francisco, CA location also considered)
Temp-to-Perm

About Our Client

Our client is a well-funded, late-stage biopharmaceutical company focused on developing targeted treatments for a serious and underserved disease area in cardiovascular medicine. With multiple programs in simultaneous late-stage development, they are building toward data readouts and potential regulatory milestones in the near term.

The company operates with a strong values-driven culture — patient-first, collaborative, and mission-oriented. They move with urgency and are committed to scientific innovation at the highest level.

Position Title: Director, GxP Quality Assurance Department: Quality & Compliance Reports To: Head of Clinical Quality Assurance

Role Overview

The Director, GxP Quality Assurance will play a central role in driving a culture of quality and ensuring compliance is embedded throughout the R&D process. This individual will manage GxP Quality Assurance functions and provide expert consultation on the interpretation of GxP regulations (GCP, GLP, GVP), guidelines, policies, and procedures — engaging and collaborating with cross-functional internal and external teams to evaluate processes and activities for adherence to relevant industry standards and company SOPs.

Essential Responsibilities

• Partners with Clinical Development and Clinical Operations; actively participates in clinical study teams to ensure GCP compliance and reviews all study-related documents and plans
• Supports and maintains the internal audit program, audit schedule, and approved vendor list
• Performs internal and external audits to ensure compliance with GxP regulations; communicates results to stakeholders and authors audit reports
• Supports QMS processes including CAPAs, deviation management, risk management, change control, and quality complaint handling
• Monitors, tracks, and trends GxP non-conformances, deviations, and CAPAs
• Leads or supports audit and inspection activities including vendor assessments and regulatory inspections
• Leads or supports backroom activities during regulatory authority inspections; assists with inspection readiness
• Interprets global legislation, regulations, and guidance to develop or update policies and standards; identifies gaps and redundancies
• Builds and maintains cross-functional relationships to promote GxP compliance awareness across the R&D organization
• Supports training initiatives on processes, new regulations, and systems
• Contributes to compliance metrics and management review

Qualifications

• Bachelor's degree in a scientific discipline
• Substantial pharmaceutical or biotechnology industry experience with in-depth QMS knowledge, typically 10+ years
• Meaningful tenure in a QMS environment spanning discovery, non-clinical, and clinical development
• Direct experience with internal and external clinical systems and process audits
• Experience auditing Clinical Investigator sites and clinical vendors
• SOP development experience
• Strong GCP background required; GLP and/or GVP experience a plus
• Strong interpersonal, negotiation, and leadership skills — collaborative, partner mentality essential
• Excellent written and verbal communication skills; experience in global, cross-functional team environments
• Expertise in Root Cause Analysis, CAPA development, and Risk Management methodology
• Decisive, proactive, and solutions-oriented
• Proficiency in MS Office suite and virtual collaboration tools
• Ability to travel as needed
• Ability to be on-site regularly in the New Jersey office (specific requirements discussed during the process)
  
  
• Compensation: Hourly Pay Range: $100– $130 per hour
  The hourly rate offered will be commensurate with experience, skills, qualifications, and other relevant factors.
  
  
• Benefits Overview: For contractors engaged through Summit Strategic Search, eligibility for benefits is determined by the specific terms of the contract and may include:
  
  • Medical, Dental, and Vision insurance options.
    
  • Paid Sick Leave (consistent with applicable state law).
    
  • Paid Time Off (PTO) and/or holiday pay.
  
  
• About the Search: This search is being managed by Summit Strategic Search on behalf of our client. This is a contract-based assignment where we the recruitment and employment administration. While you will be engaged through our firm, the end client retains final authority over the selection of personnel for their project team. All offers of engagement are contingent upon the end clients approval, project requirements, and successful completion of the onboarding process.
  
• Equal Opportunity Commitment: We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity or expression, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law.
  
• Accommodations & Support: We are committed to providing reasonable accommodations for qualified individuals with disabilities during the application and interview process. If you require assistance, please contact us at admin@summitstrategicsearch.com. We maintain a zero-tolerance policy for harassment and provide all contractors with dedicated reporting channels to ensure a safe, professional work environment.
  
• Onboarding Requirements: Due to the regulated nature of our clients industry and the requirement for on-site presence in [Location of Job], all candidates must successfully complete the end clients onboarding protocols. This typically includes a background check, drug screening, and adherence to site-specific security and health policies.