Quality Director

PSC Biotech • Greater New York City, NY

4d • $125,000 - $155,000

About The Position

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.

Requirements

• 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.

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.

Benefits

• W2 temp roles include our Medical and sick time benefits.
• Adhering to the requirements of New York's law on salary transparency, the salary bracket for this role is set between $125,000 - $155,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

What This Job Offers

• Job Type: Full-time
• Career Level: Director