Regional Quality Director

Job Summary

Want to Expand
your career-development potential,
your ability to help donors and patients,
and your access to professional opportunities?

We’re growing fast.
[You can, too!]

There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you’re someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a: Regional Quality Director

This is What You’ll Do

• Direct and manage quality management teams across multiple plasma centers, providing guidance, support, and direction to ensure high performance.
• 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, ensuring proper investigation, resolution, and inspection readiness.
• Review and approve critical quality documents, including SOPs, work instructions, and validation protocols.
• Oversee the collection, analysis, and reporting of 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 and staff for professional growth.
• Perform other duties as assigned.

This is What it Takes

• 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.

Do Satisfying Work. Earn Real Rewards and Benefits

We’re widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel.

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