Regional Quality Manager

Kedrion Biopharma GmbH; Fort Lee (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

Kedrion Biopharma Inc. is seeking a Regional Quality Manager to lead quality across a regulated plasma collection network. You will ensure regulatory compliance, oversee QA activities, and partner with center leadership to safeguard product integrity and donor safety.

This role requires directing QA teams, implementing SOPs, and driving continuous improvement. The position emphasizes risk management, cross-site leadership, and travel up to 90% to support multiple centers.

Qualifications

• Bachelor’s degree (BS/BA) or equivalent.
• 5+ years of experience in the plasma or a related regulated industry.
• Experience with FDA/EMA regulatory requirements.
• Experience with cGMP, quality systems in biological manufacturing or blood/plasma collection.
• Experience managing remote or multi-site teams.
• Ability to travel up to 90% of working time.

Responsibilities

• Ensure compliance with cGMP, SOPs, and regulatory requirements across the region.
• Oversee QA activities across plasma collection centers.
• Supervise QA staff and ensure quality systems are followed.
• Act as QA subject matter expert to leadership and QA teams.
• Identify and mitigate quality/compliance risks related to SOPs, training, equipment, and processes.
• Authorize production/product release stoppages when issues arise.
• Develop and implement SOPs, validation, and CAPA processes.
• Support investigations and documentation of non-conformances and incidents.
• Monitor compliance using the Donor Management System (DMS).
• Collaborate cross-functionally on continuous improvement initiatives.
• Manage remote/direct reports including hiring, training, performance, and workforce planning.
• Set performance standards and drive employee engagement.

Skills

Quality management

Regulatory compliance

cGMP

Cross-site leadership

Risk management

Education

Bachelor’s degree (BS/BA)

Tools

DMS

Job description

KEDPLASMA is a subsidiary of Kedrion Biopharma Inc. KEDPLASMA specializes in the collection and procurement of high-quality plasma that is processed into plasma-based therapies. Kedrion Biopharma Inc. is an international company specializing in the collection and fractionation of blood plasma to produce and distribute plasma-derived therapeutic products. Our therapies help treat and prevent serious diseases, including Hemophilia, Primary Immune System Deficiencies, and Rh-Sensitization.

Job Summary

Lead quality across a highly regulated, mission-driven environment where safety, compliance, and continuous improvement come first.
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
• Supervise and support Quality department employees, ensuring consistent execution of quality systems and expectations
• Serve as a quality and compliance subject matter expert to center leadership and QA staff
• Identify, evaluate, and elevate quality or compliance risks related to SOPs, training, equipment, and processes
• Authorize production or product release stoppage when quality or compliance issues are identified
• Participate in the development, review, and implementation of SOPs and validation processes, ensuring timely and accurate adoption
• 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
• Monitor and verify 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 will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

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 are determined based on relevant experience, education, and certifications.
If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team [e-mail].

Employee Benefits:At Kedrion Biopharma Inc., we believe in taking care of our people. Our benefits package is designed to support your health, happiness, and future, including:

• 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!

For specific inquiries please reach out to us

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.