Posting Start Date: 8/13/26
State/Province: New Jersey
Job Location: Fort Lee
Place of Employment:
Contract Duration: Permanent
Hiring Pay Range Min: 87000
Hiring Pay Range Max: 120000
Regional Quality Manager
Job SummaryLead 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 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
- 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
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 at
[email protected].
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
