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Sr. Manager, Quality Systems

Company: Beacon Hill Staffing Group - Pharma
Location: Lowell
Posted on: October 16, 2020

Job Description:

Sr. Manager will be responsible for the deployment, administration, and management of quality systems. Sr. Manager with ensure that quality systems are compliant with regulatory requirements and company policies and business needs. Additional responsibilities include, but are not limited to authoring, reviewing and approving Policies, Standard Operating Procedure, and other related GXP documents in support of the Quality Systems Manual (QMS). The incumbent will work directly with the Director, Quality Assurance to ensure that company goals and objectives are met and that compliance risks are identified, mitigated, and communicated to senior management. Such activities may include, but are not limited to oversight of Contract Manufacturing Organizations (CMOs) in the transfer and manufacture of Clinical Trial Material (CTM) for programs. CMO audits and selection, review and approval of master production documents (Batch Records, Specifications, etc.) disposition of product, analytical qualifications, etc. Lead initiatives for the development, deployment, and management of Voyager Quality System (Document Management, Investigations, Corrective and Preventative Actions, Change Control, Technology Transfer, etc. Develop, review, contribute and approve Policies and SOPs in support of the Quality Systems Manual and other functional areas. Development and implementation of Quality Metrics related to Quality Systems Develop and maintain tracking logs and files for Quality Systems. Develop, conduct and maintain New Employee Quality Orientation and Quality Refresher Training. Development Technical Quality Agreements for CMOs and CROs. Conduct GMP audits of CMOs, CROs and suppliers as directed. Conduct internal compliance audits. Participate in the development of Regulatory Authority inspection strategies. Represent Quality in cross-functional Program Teams. Effectively communicate progress and issue resolution to the Director, Quality Assurance and key stakeholder of the Program Teams. Additional Responsibilities include, but are not limited to: o Review and approval of CMO Master Batch Records (MBRs) o Review and approval of executed batch records, and disposition product with input from the Director of Quality Assurance. o Participate with Manufacturing Sciences in investigations of deviations ensuring the development of Corrective Actions and Preventative Actions (CAPA) and approve investigation and deviation reports. o Review and approve Technical Transfer Documents, CMO Protocols & Reports inclusive of analytical qualification. o Participate in the preparation, review and audit of Chemistry and Manufacturing Control (CMC) sections. Qualifications and Experience: A minimum of a Bachelor's degree in Chemistry, Pharmacy, Biochemistry or related discipline is required A minimum of 15 years of QA GMP experience in biotech/pharmaceutical environment working with various quality systems and CMOs is required GCP and GLP experience is preferred Demonstrated success managing quality systems such as, deviations, change controls, etc. Ability to work independently and conduct of GMP compliance audits of CMOs and/or suppliers in the production of Biological Drug Substance and Drug Product Demonstrated knowledge and understanding of quality compliance principals with specific focus on GMPs (CRO compliance knowledge a plus)

Keywords: Beacon Hill Staffing Group - Pharma, Lowell , Sr. Manager, Quality Systems, Executive , Lowell, Massachusetts

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