Quality Director
About The Position
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. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role 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
- Depending on the candidate’s experience, qualifications, and evolving business needs, this role may be structured as either a temporary or full-time position. Temporary roles include our medical and sick time benefits. Full-time positions are fully benefited in accordance with company offerings.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
51-100 employees
