Traveling QA Lead, Plasma Quality & Compliance

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

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.