Sr Manager, Mqa

Fresenius Kabi•Wilson, NC

41d•$140,000 - $160,000

About The Position

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.

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.

Responsibilities

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.