Manager of Quality Operations
Cambridge, MA | Contract
Under the guidance of the Sr. Manager, this individual will manage the Contract Manufacturing Organizations (CMOs) involved in production of drug product on-behalf of the client, to supply early stage clinical trials. In this role, the person will be responsible for ensuring product quality at drug product contract manufacturing operations while developing and maintaining relationships. Leading by influence, the individual must be well organized and have excellent oral and written communication skills to effectively interact with external manufacturers to ensure quality compliance needs are met in a timely manner. This includes collaborative interactions such as due diligence, establishing and maintaining quality agreements, review of change controls, deviations, batch review and disposition and metrics as well as providing support to build effective quality systems at the vendor and supporting continuous improvement activities. This individual will work closely with the CMOs, manufacturing, Quality Control, regulatory, quality systems, product quality owners, and the clinical and commercial supply chain operations teams to maintain drug product supply.
-Maintaining relationships with partner CMO's, developing and maintaining quality metrics.
-Support technology transfers, analytical method transfers, and process validation at CMOs in a quality role
-Review of event documentation such as Batch records, Deviation investigations, Change Controls, and on-site coverage of CMO activities as needed
-Review vendor protocols and reports
-Attend routine business meetings as the quality representative
-Supporting audits and inspections
-Perform functions and makes decision consistent with cGMPs, GDPs and quality governance
-Minimum of 8 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment
-Good understanding of FDA and EMA regulations and guidelines
-Good understanding of CMO mediated Supply Chain activities
-Excellent organizational, communication, and interpersonal skills.
Education: Minimum, a BS degree in life sciences, engineering