This position is responsible for overseeing KBI Finished Products, supporting the Product Distribution Release, and managing the Product Returns process. The position also involves providing support for quality tasks related to KBI’s contract manufacturing organizations (CMOs) and contributing to KBI’s Quality Management system initiatives.

Product Distribution and Product Returns

• Manage and maintain the product distribution releases process

• Establish and maintain a Product Returns Program for assigned product lines, ensuring compliance with current laws and regulations.

• Perform oversite of 3 rd Party Logistic (3PL) quality management systems: facilities; processes and documents; repackaging/relabeling; complaint handling; recall management; returns management; counterfeit handling; and self-inspection to ensure compliance with internal policies, procedures and regulatory requirements

• Support and collaborate closely with Logistics and Quality staff to resolve GDP issues related to KBI distributed products.

• Manage and support quality events for distributed products

Quality Assurance

• Support management of the Quality system for the KBI Fort Lee site.

• Evaluate, contribute and approve change controls, risk assessments, quality events, CAPAs, and other investigations as they relate to Quality implementation plans

• Implement and oversee Quality Agreements

• Plan and lead audits at CMOs and 3PLs, ensuring CAPA implementation and effectiveness

• Support quality activities for KBI CMO products and KBI licensed products.

• Manage and support Global and ROW quality activities and tasks, as assigned

• Manage and support internal/external audits, and inspections as assigned.

• Manage internal procedures development and periodic reviews, in compliance with industry standards

• Establish and maintain the Product Complaints Program, in compliance with current laws and regulations.

• Provide Quality training and ensuring its ongoing effectiveness and alignment with job functions

• Perform other duties and special projects, as assigned

Contract manufacturers (CMO)

• Support day-to-day activities, as the Quality representative, with KBI CMOs

Artwork Management

• Manage and maintain labeling and artwork for assigned product lines.

• Ensure label content meets Regulatory, and FDA requirements.

• Work closely with graphics and print vendors.

• Interpret governmental regulations and have a basic understanding of the requirements for pharmaceutical product labeling

Requirements:

• Bachelor's Degree in Engineering, Biochemistry, Biology or equivalent discipline.

• Minimum 5 years relevant CGMP experience within pharmaceutical industry with quality auditing and pharmaceutical label control experience

• Hands-on experience with implementing GMP Quality Systems

• Strong knowledge of Master Control preferred

• Strong knowledge and experience in the manufacture and control of biologics, sterile product manufacturing

• Excellent verbal and written skills

• Demonstrated ability to work as a team member and to exercise independent decision making

• Ability to be proactive and demonstrated ability to implement continuous improvement initiatives.

• Project Management Experience: Demonstrated ability to work as a team member and to exercise independent decision-making.

• Continuous Improvement and Change Agent: Demonstrated ability to identify, initiate and manage change.

This position will require at least 2 days in office per week.

Kedrion Biopharma offers a number of benefits to qualifying employees, including:

- Medical, vision and dental insurance

- Life and AD&D insurance

- Paid holidays

- PTO accrual

- and much more!

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status. Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.