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Quality Manager - Pharmaceutical

Company: Michael Page
Location: Raleigh
Posted on: January 12, 2021

Job Description:

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.SummaryThe Manager, Quality Assurance is responsible for managing QMS activities at Raleigh, NC sites, Managing Contract Manufacturing Operations/Vendor management activities. This position also contributes to the completion of routine technical tasks and any additional quality task identified.Client DetailsLarge Pharmaceutical Manufacturing CompanyDescription* Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site* Maintain quality system controls to ensure no critical and major market complaints* Ensure that all statutory and regulatory compliance are regularly monitored and are in a state of compliance as applicable* Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency* Preparation, review and updating of Standard Operating Procedures for all the supporting departments and ensuring compliance to written procedures* Handling all internal Deviations, NCRs, CAPA and Change controls and ensuring proper investigation and CAPA implementation/closure as applicable* Tracking and trending of quality events.* Handling of employee Trainings* Handling Regulatory/Customer inspections* Performing both internal and external vendor audits including testing labs* Tracking and monitoring of PQC and DQRS communications* Handling of FAR and Recall activities* Handling of SAP related activities pertains to Quality* Management of Quality Agreements* Due diligence, Qualification, monitoring of Vendors/CMOs and ensure compliance towards batches received from CMOs and In Licensed Vendors* Management of Approved Vendor List* Overseeing of Canada Quality Management System in coordination with Canada Operations* Vendor management* Compliance towards timely batch releases and Product launches in Canada* Tracking and monitoring of PQC* Ensure all required Manufacturing Site, External Testing and Health Canada required documentation is current and ready for any inspection* Provide support for reviewing any required technical documents for Canada Operations* Coordinating method transfer activities* Coordinating for receipt of GMP documents and ensure their availability in Canada Share drive* Support during Health Canada Inspections and self-inspections* Coordinating with all department personnel for execution of QMS procedures* Establishes good working relation with Contract Manufacturers and Vendors* Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols* Managing activities regarding audits of suppliers and contract labs in support of vendor certification program and CMO qualificationsProfile* Bachelors / Master's degree in Life Sciences or Technical/Engineering field, or closely related scientific disciplineExperience:* Minimum of 8 years' experience in Manufacturing QA, Analytical, and Sterile Manufacturing experience required* Understanding of cGMPs, FDA, DEA regulations, and industry guidelines, as well as international regulatory guidelines* Strong technical writing skills requiredJob OfferVery competitive pay and benefits.

Keywords: Michael Page, Raleigh , Quality Manager - Pharmaceutical, Executive , Raleigh, North Carolina

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