We are looking for a Quality Operations Manager, working in the Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States.
Manages the Contract Manufacturing Organizations (CMOs) involved in production of drug product on-behalf of the company, to supply early stage clinical trials.
Ensures product quality at drug product contract manufacturing operations while developing and maintaining relationships.
Leads 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.
Works 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.
The pay we are offering is 52 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
BS degree in life sciences, engineering or related field
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
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.