SR MANAGER, MQA

at  Fresenius Kabi

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.
Responsibilities

REQUIREMENTS

• B.S. Science with a minimum of 15 years work related experience including a minimum of five years as manager or above. Advanced degree strongly preferred.
• Position requires advanced training or experience in cGMPs and GLPs
• Excellent verbal and written communication skills required
• Required to provide clear communication of investigational circumstances to supervisors so that proper risk management decisions can be facilitated by senior management
• A very strong working knowledge of regulatory requirements and ISO requirements in the parenteral pharmaceutical industry as well as other legal requirements for business operations.
• Expected to provide a motivated, technically competent, supportive work group for the facility and the company to support various company agendas and is accountable for the continuous flow of accurate, complete validation, finished product, or in-process reports to facilitate continuous release of finished goods.
  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 match, and wellness 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

Please refer the Job description for details