Traveling QA Leader - Donor Center Compliance

KEDPLASMA; Fort Lee (NJ); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health & Wellness – Full medical, and…

Financial Security – Life insurance, A

Work-Life Balance – Paid time off

Career Growth – Training programs

Extra Perks – Employee discounts

Job summary

Kedrion Biopharma Inc. is seeking a Traveling Quality Assurance Manager to safeguard product quality, donor and employee safety, and regulatory compliance across assigned donor centers. This travel-intensive role involves audits, training, CAPAs, and continuous improvement across multiple locations.

The position requires a Bachelor’s degree with 3–5 years in plasma or related regulated industries, and up to 80% travel. Strong communication and Microsoft Office skills are essential.

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 regulatory requirements
• Promote understanding and consistent application of regulations and policies across the region
• Partner with management to support product quality, donor safety, and employee safety initiatives
• Monitor quality performance and facilitate QA activities to maintain inspection readiness
• Lead, train, coach, and mentor QA staff to strengthen performance and regulatory knowledge
• Identify quality/compliance issues and evaluate contributing factors
• Review and update SOPs and validation processes at center and corporate level
• Ensure timely implementation of new or revised SOPs across donor centers
• Support donor center operations with investigations and documentation related to non-conformances and other reports
• Develop and track corrective and preventive actions
• Review equipment calibration and maintenance documentation
• Track donor center compliance using the Donor Management System
• Encourage continuous quality improvement initiatives
• Review epidemiological data submissions and identify root causes for corrective actions
• Provide support for traveling quality projects and on-site quality coverage
• Support donor centers for audits by regulators and customers

Skills

cGMP knowledge

Regulatory compliance

QA leadership

Donor safety

English proficiency

Education

Bachelor’s degree in a relevant field

Tools

Donor Management System

Microsoft Office

Job description

Kedrion Biopharma Inc. is seeking a Traveling Quality Assurance Manager to safeguard product quality, donor and employee safety, and regulatory compliance across assigned donor centers. This travel-intensive role involves audits, training, CAPAs, and continuous improvement across multiple locations.

The position requires a Bachelor’s degree with 3–5 years in plasma or related regulated industries, and up to 80% travel. Strong communication and Microsoft Office skills are essential.