PSC Biotech® Corporation · 23 hours ago
Quality Director
New York, NY, US
Full-time, Contract
Onsite
Director/Executive
$125K/yr - $155K/yr
10+ years expPSC Biotech® Corporation provides essential services to the life sciences industry, ensuring compliance with regulatory standards. They are seeking a highly experienced Quality Director to lead quality governance and compliance oversight across clinical development and research activities, ensuring alignment with global regulatory expectations.
BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental
No H1B
Responsibilities
Lead and execute the organization’s clinical and research quality strategy, ensuring alignment with GCP, GLP, internal standards, and global regulatory requirements
Serve as the senior authority for quality governance, compliance oversight, and inspection readiness across development programs
Establish, maintain, and continuously improve the Quality Management System, including SOP governance, training, deviation management, and CAPA processes
Design and oversee risk‑based audit programs and provide quality oversight of CROs, laboratories, and other external partners
Ensure regulatory inspection readiness through strong documentation practices, data integrity controls, and TMF oversight
Partner cross‑functionally to integrate quality into clinical development plans, protocols, and operational execution
Lead quality risk assessments, track key quality metrics, and communicate risks and trends to executive leadership
Build, mentor, and lead a high‑performing quality organization while fostering a culture of integrity and continuous improvement
Qualification
Required
Advanced degree in a related technical field
10–25 years of progressive experience in quality leadership within the pharmaceutical or biotechnology industry
Deep expertise in GCP and GLP regulations supporting clinical development and research
Demonstrated success leading quality systems, audit programs, and inspection readiness initiatives
Strong understanding of global regulatory frameworks (FDA, EMA, ICH, and related authorities)
Proven ability to influence senior stakeholders and operate effectively in a matrixed environment
Exposure to complex or specialized therapeutic areas
Background in quality support for strategic partnerships, licensing transactions, or acquisitions
Prior experience building or scaling quality organizations in growing or evolving companies
Must be authorized to work in the U.S
No C2C at this time
Benefits
Medical and sick time benefits
Fully benefited in accordance with company offerings
Company
PSC Biotech® Corporation
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
John Clapham
CEO
Recent News
2025-12-18
2025-10-20
Company data provided by crunchbase