Quality Director

Overview

Greater New York City, United States | Posted on 02/02/2026

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

We are hiring a highly experienced Quality Director to join our team. The Director of Quality provides enterprise‑level leadership for quality governance, compliance oversight, and risk management across clinical development and research activities. This role is accountable for ensuring that clinical programs, laboratory operations, and external partners operate in alignment with global regulatory expectations and internal quality standards. As a senior leader, the Director of Quality partners closely with executive and functional leadership to embed quality by design, maintain inspection readiness, and support company-wide development programs.

• 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.

• 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.

Equal Opportunity Employment Statement

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs.

Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.