SR MANAGER, MQA Position Available In Wilson, Tennessee
Tallo's Job Summary: The SR MANAGER, MQA is responsible for overseeing Manufacturing Quality Assurance at the Wilson facility, ensuring timely delivery of results and compliance with cGMP and regulatory standards. This role involves managing the MQA program, interacting with various departments, and participating in regulatory inspections. The salary range for this position is $140,000 - $160,000, with comprehensive benefits including 401(k) contributions, paid time off, and health coverage. Fresenius Kabi is hiring for this position, seeking candidates with a BS in Science and 15 years of relevant experience.
Job Description
Job Description:
Job Summary
POSITION SUMMARY
Responsible for administration of Manufacturing Quality Assurance(MQA) to assure timely delivery of results to manage the companyobjectives and production as well as new product introduction ontime. Reviews procedures of quality systems, validation, changecontrol, manufacturing discrepancy investigations, cGMP/regulatorycompliance, and protocols. Participates in regulatory inspectionsof the Wilson facility. Assumes responsibility for major projectsor contract manufacturing as assigned by the Director of QualityAssurance. Works independently of direct supervision but interacts with alllevels within the site organization on a daily basis. Interactsregularly with Logistics, Operations and Quality Control. Routinelyinteracts with Regulatory Agencies including, but not limited to,FDA and DEA. This position directly manages the MQA program and associatedpersonnel for the Wilson facility.
Salary Range:
$140,000 – $160,000 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 thoughtfullycrafted to ensure our colleagues live healthy lives and havesupport when it matters most. Benefits offered include a 401(k)plan with company contributions, paid vacation, holiday andpersonal days, employee assistance program, and health benefits toinclude medical, prescription drug, dental and visioncoverage.
Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THEINCUMBENT
Administers, reviews, and approves master batch records andstandard operating procedures, validation documentation, andmanufacturing discrepancy reports. Provides cGMP guidance to alldepartments engaged in the production of pharmaceutical products. Assumes responsibilities for the daily functional activitiesand has authority to make decisions for the MQA department ininternal and external meetings. Assumes responsibilities for majorprojects, such as contract manufacturing, new products, or facilityrenovations, as assigned by the Director of QA. Activelyparticipates in and supports Continuous Improvement initiatives andteams. Develops personnel, administers department budget, and plansfor future resource needs about personnel, equipment, and facility. Department SME (Subject Matter Expert) regarding operationaland MQA systems. Assists in causal factor analysis for events andcustomer complaints as needed. Provides technical details asrequired in a manner consistent with the confidential andproprietary nature of the information. Participates in Regulatory/FDA inspections by providinginformation or expediting/obtaining information required by theinspectors. Schedules and conducts pre-inspection review ofoperations and follow-ups where corrective action is required. Promotes continual improvement taking quality controlaccountability for the effectiveness of
ISO 14001
EnvironmentalManagement System and
ISO 50001
Energy Management System withinOperations. Responsible for ensuring compliance to OccupationalHealth and Safety is met under
ISO 45001.
Responsible for ensuring Health, Safety and Environmentalrequirements are adhered to within Operations.
REQUIREMENTS B.S.
Science with a minimum of 15 years work related experienceincluding a minimum of five years as manager or above. Advanceddegree strongly preferred. Position requires advanced training or experience in cGMPs andGLPs Excellent verbal and written communication skills required Required to provide clear communication of investigationalcircumstances to supervisors so that proper risk managementdecisions can be facilitated by senior management A very strong working knowledge of regulatory requirements andISO requirements in the parenteral pharmaceutical industry as wellas other legal requirements for business operations. Expected to provide a motivated, technically competent,supportive work group for the facility and the company to supportvarious company agendas and is accountable for the continuous flowof accurate, complete validation, finished product, or in-processreports to facilitate continuous release of finishedgoods.
Additional InformationWe offer an excellent salary andbenefits package including medical, dental and vision coverage, aswell as life insurance, disability,401K with company contribution,andwellness program. Fresenius Kabi is an EqualOpportunity/Affirmative Action employer. All qualified applicantswill receive consideration for employment without regard to race,color, religion, sex, national origin, citizenship, immigrationstatus, disabilities, or protected veteran status.
