SR MANAGER, MQA

Job Summary

POSITION SUMMARY

Responsible for administration of Manufacturing Quality Assurance (MQA) to assure timely delivery of results to manage the company objectives and production as well as new product introduction on time. Reviews procedures of quality systems, validation, change control, manufacturing discrepancy investigations, cGMP / regulatory compliance, and protocols. Participates in regulatory inspections of the Wilson facility. Assumes responsibility for major projects or contract manufacturing as assigned by the Director of Quality Assurance.

Works independently of direct supervision but interacts with all levels within the site organization on a daily basis. Interacts regularly with Logistics, Operations and Quality Control. Routinely interacts with Regulatory Agencies including, but not limited to, FDA and DEA.

This position directly manages the MQA program and associated personnel for the Wilson facility.

Salary Range : $140,000 - $160,000

Position is eligible to participate in an annual bonus plan with a target of 14% of the base salary.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Administers, reviews, and approves master batch records and standard operating procedures, validation documentation, and manufacturing discrepancy reports. Provides cGMP guidance to all departments engaged in the production of pharmaceutical products.
• Assumes responsibilities for the daily functional activities and has authority to make decisions for the MQA department in internal and external meetings. Assumes responsibilities for major projects, such as contract manufacturing, new products, or facility renovations, as assigned by the Director of QA. Actively participates in and supports Continuous Improvement initiatives and teams.
• Develops personnel, administers department budget, and plans for future resource needs about personnel, equipment, and facility.
• Department SME (Subject Matter Expert) regarding operational and MQA systems. Assists in causal factor analysis for events and customer complaints as needed. Provides technical details as required in a manner consistent with the confidential and proprietary nature of the information.
• Participates in Regulatory / FDA inspections by providing information or expediting / obtaining information required by the inspectors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.
• Promotes continual improvement taking quality control accountability for the effectiveness of ISO 14001 Environmental Management System and ISO 50001 Energy Management System within Operations. Responsible for ensuring compliance to Occupational Health and Safety is met under ISO 45001.
• Responsible for ensuring Health, Safety and Environmental requirements are adhered to within Operations.

REQUIREMENTS

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.