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SR MANAGER, MQA (Wilson)

SR MANAGER, MQA (Wilson)

Fresenius Kabi USA, LLCWilson, NC, US
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Job Summary

Responsible for the administration of Manufacturing Quality Assurance (MQA) to ensure the timely delivery of results, supporting company objectives, production, and new product introductions. Reviews procedures related to quality systems, validation, change control, manufacturing discrepancy investigations, cGMP / regulatory compliance, and protocols. Participates in regulatory inspections of the Wilson facility. Manages major projects or contract manufacturing as assigned by the Director of Quality Assurance.

This position operates independently without direct supervision but interacts daily with all levels within the site organization, including Logistics, Operations, and Quality Control. Regular interactions with Regulatory Agencies such as the FDA and DEA are also required.

The role directly manages the MQA program and personnel at the Wilson facility.

Salary Range : $140,000 - $160,000. Final pay depends on experience, education, knowledge, skills, and abilities.

Our benefits include a 401(k) plan with company contributions, paid vacation, holidays, personal days, an employee assistance program, and comprehensive health coverage including medical, dental, vision, and prescriptions.

Responsibilities

Principal Activities

  • Administers, reviews, and approves master batch records, SOPs, validation documents, and discrepancy reports. Provides cGMP guidance across departments involved in pharmaceutical production.
  • Leads daily functional activities and decision-making for the MQA department. Oversees major projects such as contract manufacturing, new products, or facility renovations. Supports Continuous Improvement initiatives.
  • Develops personnel, manages department budget, and plans resource needs for personnel, equipment, and facilities.
  • Serves as SME for operational and MQA systems. Assists in causal analysis for events and customer complaints, maintaining confidentiality.
  • Participates in regulatory inspections, providing necessary information and conducting pre-inspection reviews.
  • Promotes continual improvement and ensures compliance with ISO 14001, ISO 50001, and ISO 45001 standards for environmental, energy, health, and safety management.
  • Ensures adherence to Health, Safety, and Environmental requirements within Operations.

Requirements

  • B.S. in Science with at least 15 years of related experience, including five years in a managerial role. An advanced degree is strongly preferred.
  • Extensive training or experience in cGMPs and GLPs.
  • Excellent verbal and written communication skills.
  • Ability to clearly communicate investigation findings for risk management.
  • Strong knowledge of regulatory and ISO requirements in the parenteral pharmaceutical industry and legal business operations.
  • Motivated, technically competent, and supportive leadership to ensure continuous quality and compliance.

    • Additional Information

    We offer a competitive salary and benefits package, including medical, dental, vision, life insurance, disability, 401(k) with company contribution, and wellness programs.

    Fresenius Kabi is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or veteran status.

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    Manager • Wilson, NC, US