Regional Quality Manager

Job Summary

The Regional Quality Manager is responsible for ensuring quality, regulatory compliance, and operational excellence across an assigned region. This role leads and supports Quality teams while partnering closely with center leadership to maintain compliance with cGMP, SOPs, and global regulatory requirements. The position plays a critical role in safeguarding product integrity, donor safety, and company standards across plasma collection operations.

What you'll do

• Ensure compliance within the assigned region with cGMP, SOPs, company standards, and applicable FDA, EMA, customer, and other regulatory requirements
• Oversee, monitor, and facilitate all Quality Assurance activities across assigned plasma collection centers
• Serve as a quality and compliance subject matter expert to center leadership and QA staff
• Identify, evaluate, and escalate quality or compliance risks related to SOPs, training, equipment, and processes
• Authorize production or product release stoppage when quality or compliance issues are identified
• Support investigations and documentation related to non-conformance reports, post-donation reports, errors, accidents, and complaints
• Develop, implement, and track corrective and preventive actions, ensuring timely initiation, completion, and closure
• Maintain compliance using the Donor Management System (DMS)
• Review epidemiological data and support PPTA monitoring requirements
• Assist centers responding to Viral Marker Alerts, including evaluation of contributing factors and implementation of corrective actions
• Support equipment qualification, calibration, and maintenance documentation reviews for completeness and compliance
• Collaborate cross-functionally to support continuous improvement initiatives and company objectives
• Manage direct reports, including hiring, training, coaching, performance management, and workforce planning
• Establish performance standards, conduct evaluations, and promote employee engagement and retention
• Address employee concerns and grievances in partnership with leadership and Human Resources

Qualifications and need-to-know

• Bachelor’s degree (BS or BA) or equivalent combination of education and experience
• Minimum of five years of experience in the plasma industry or a related regulated industry
• Working knowledge of FDA and EMA regulatory requirements
• Experience with cGMP, quality systems, and compliance in biological manufacturing or blood/plasma collection environments
• Experience managing remote or multi-site teams
• Ability to travel up to 90% of working time, including overnight travel

Employment eligibility verification

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. Commitment

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Salary ranges

Salary ranges are determined based on relevant experience, education, and certifications.

Employee Benefits

• Health & Wellness – Full medical, dental, and vision coverage
• Financial Security – Life insurance, AD&D, and retirement savings plans
• Work-Life Balance – Paid time off, sick leave, and paid holidays
• Career Growth – Training programs and development opportunities
• Extra Perks – Employee discounts, wellness initiatives, and more!