Traveling Quality Manager

KEDPLASMA; Fort Lee (NJ); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health & Wellness

Financial Security

Work-Life Balance

Career Growth

Extra Perks

Job summary

Kedrion Biopharma Inc. is seeking a Traveling Quality Assurance Manager to safeguard product quality, donor safety, and regulatory compliance across assigned donor centers. The role involves traveling up to 80% and mentoring QA teams to drive continuous improvement.

You will work with regional leadership to ensure adherence to cGMP, SOPs, and company standards while leading audits, investigations, and corrective actions across multiple locations.

Qualifications

• Bachelor’s degree required with a minimum of three years of experience in the plasma industry, or four to five years of commensurate experience in a related regulated industry.
• Ability to travel up to 80% by plane and/or car to donor centers.
• Strong written and verbal communication skills, including the ability to conduct oral presentations.
• Proven ability to work effectively with diverse teams and stakeholders.
• Ability to speak, read, and write in English.
• Professional appearance and demeanor.
• Strong technical aptitude, including experience with donor management systems and Microsoft Office applications.

Responsibilities

• Ensure assigned donor centers maintain compliance with cGMP, SOPs, company standards, and applicable FDA, EMEA, customer, and other regulatory requirements.
• Promote understanding and consistent application of state and federal regulations, industry expectations, and corporate policies across the assigned region.
• Partner with Regional and Center Management to support product quality, donor safety, and employee safety initiatives.
• Monitor quality performance and facilitate required QA activities to maintain continuous inspection readiness.
• Lead, train, coach, and mentor Quality Assurance Managers and Quality Assurance Specialists to strengthen performance and regulatory knowledge.
• Identify potential, serious, or recurring quality and compliance issues and evaluate contributing factors such as procedures, training, facilities, and equipment.
• Participate in the review, development, and updating of SOPs and validation processes at both the center and corporate level.
• Ensure timely, accurate, and compliant implementation of new or revised SOPs across donor centers.
• Support donor center operations with investigations and documentation related to Non-Conformance Reports, Post Donation Reports, error and accident reports, and complaints.
• Develop, implement, and track corrective and preventive actions, ensuring timely completion and proper closure.
• Assist with the review and qualification of equipment calibration and maintenance activities and verify documentation completeness.
• Track and verify donor center compliance using the Donor Management System.
• Actively encourage and participate in continuous quality improvement initiatives.
• Review epidemiological data submissions and support centers on Viral Marker Alert by identifying root causes and implementing corrective actions.
• Provide support for special traveling quality projects, including warehouse inventory reconciliation and release activities.
• Provide temporary coverage and on-site quality support as directed by Regional Quality Management.
• Support donor centers in preparation for and during regulatory and customer audits.

Skills

Travel readiness

Communication skills

Team collaboration

English proficiency

Technical aptitude

Education

Bachelor's degree

Tools

Donor management systems

Microsoft Office

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 the network—on the ground, on the move, and at the center of compliance.

As a Traveling Quality Assurance Manager, you will play a critical role in safeguarding product quality, donor and employee safety, and regulatory compliance across assigned donor centers. Working closely with regional and center leadership, you will ensure adherence to cGMP, SOPs, and company standards while mentoring quality teams and driving continuous improvement. This is a highly visible, travel-intensive role that offers exposure to audits, corrective actions, training, and special quality initiatives across multiple locations.

What you'll do

• Ensure assigned donor centers maintain compliance with cGMP, SOPs, company standards, and applicable FDA, EMEA, customer, and other regulatory requirements
• Promote understanding and consistent application of state and federal regulations, industry expectations, and corporate policies across the assigned region
• Partner with Regional and Center Management to support product quality, donor safety, and employee safety initiatives
• Monitor quality performance and facilitate required QA activities to maintain continuous inspection readiness
• Lead, train, coach, and mentor Quality Assurance Managers and Quality Assurance Specialists to strengthen performance and regulatory knowledge
• Identify potential, serious, or recurring quality and compliance issues and evaluate contributing factors such as procedures, training, facilities, and equipment
• Participate in the review, development, and updating of SOPs and validation processes at both the center and corporate level
• Ensure timely, accurate, and compliant implementation of new or revised SOPs across donor centers
• Support donor center operations with investigations and documentation related to Non-Conformance Reports, Post Donation Reports, error and accident reports, and complaints
• Develop, implement, and track corrective and preventive actions, ensuring timely completion and proper closure
• Assist with the review and qualification of equipment calibration and maintenance activities and verify documentation completeness
• Track and verify donor center compliance using the Donor Management System
• Actively encourage and participate in continuous quality improvement initiatives
• Review epidemiological data submissions and support centers on Viral Marker Alert by identifying root causes and implementing corrective actions
• Provide support for special traveling quality projects, including warehouse inventory reconciliation and release activities
• Provide temporary coverage and on-site quality support as directed by Regional Quality Management
• Support donor centers in preparation for and during regulatory and customer audits

Qualifications And Need-to-know

• Bachelor’s degree required with a minimum of three years of experience in the plasma industry, or four to five years of commensurate experience in a related regulated industry
• Ability to travel up to 80% by plane and/or car to donor centers
• Strong written and verbal communication skills, including the ability to conduct oral presentations
• Proven ability to work effectively with diverse teams and stakeholders
• Ability to speak, read, and write in English
• Professional appearance and demeanor
• Strong technical aptitude, including experience with donor management systems and Microsoft Office applications

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

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 at [e-mail].

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!

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.