Regional Quality Director

Want to expand your career‑development potential, help donors and patients, and gain professional opportunities?

We're growing fast at Octapharma Plasma. Our strong growth creates learning and career development opportunities across our company, especially our donation centers. If you love learning, enjoy people, and have a heart to help, we encourage you to join us as a Regional Quality Director.

The Regional Quality Director directs and manages quality management teams across multiple plasma centers, developing and implementing regional quality strategies aligned with company goals and regulatory requirements. The role ensures high performance, quality, and donor safety through continuous improvement, CAPA management, and collaboration with cross‑functional teams.

• Direct and manage quality management teams across multiple plasma centers, providing guidance, support, and direction.
• Develop and implement regional quality strategies and objectives aligned with company goals and regulatory requirements.
• Lead, monitor, and drive continuous improvement of site and regional Quality KPIs, collaborating with Operations leadership to mitigate risks, ensure product quality, and protect donor safety.
• Oversee quality assurance activities, including deviation management, Corrective and Preventive Actions (CAPA) processes, change control, and documentation management.
• Review and approve critical quality documents, including SOPs, work instructions, and validation protocols.
• Collect, analyze, and report quality data from plasma centers, using insights to identify trends, risks, and opportunities for improvement.
• Prepare and present regular quality performance reports to senior management, highlighting trends, risks, and recommended actions.
• Drive continuous improvement initiatives by collaborating with cross‑functional teams, facilitating root cause analyses, and implementing CAPAs that improve quality and efficiency.
• Collaborate with regional leadership, corporate quality leadership, and operational teams to ensure consistent alignment of quality practices and policies.
• Communicate effectively with all levels of the organization, providing clear and concise updates on quality performance, issues, and initiatives.
• Partner with Learning and Development to implement training programs, ensure staff competency, and maintain accurate training records; mentor and develop quality management staff for professional growth.
• Perform other duties as assigned.

• High school diploma or equivalent.
• Bachelor’s degree in life sciences or related field preferred.
• Three (3) years of job‑related experience in biologics, drug manufacturing, medical device facility, or FDA‑regulated environment.
• Three (3) years of experience leading people; remote management experience preferred.
• Knowledge of FDA regulations (21 CFR Part 640 Subpart G Source Plasma).
• Strategic thinker with demonstrated experience in the development and management of quality systems, exception identification and resolution, CAPA programs, and continuous improvement initiatives.
• Strong organizational skills and attention to detail.
• Excellent verbal, written, and interpersonal communication skills.
• Ability to make sound decisions and exercise good judgment.
  
  Ability to analyze data effectively.

• Formal training
• Medical, dental, and vision insurance
• Health savings account (HSA)
• Flexible spending account (FSA)
• Tuition reimbursement
  
  Employee assistance program (EAP)
• Wellness program
• 401(k) retirement plan
• Paid time off
• Company paid holidays
• Personal time