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Biogen CMO Quality Lead in Cambridge, Massachusetts

About This Role * The main purpose of this job is to remotely provide Quality oversight to activities at external manufacturing and testing organizations (i.e. CMO). As such the position holder is the Relationship Manager for all Quality matters related to that CMO with focus on assembly, labelling and packaging activities of parenteral as well as pharmaceutical products. Therefore, it is expected that this CMO Quality Lead manages compliant and un-interrupted supply of commercial products to patients while working within a cross-functional team. This position is opened in the Global External Quality department and reports to the Head Quality Packaging in Baar, Switzerland. *What You’ll Do * * Accountable for management of Quality operations activities with key/critical CMOs * Prepare and manage Quality management Review, Annual Product Review performance and Quality agreement * Ensure that the CMOs maintain quality systems that are in the state of compliance and aligned with Biogen expectations * Ensure appropriate corrective and preventive actions are defined, implemented and that their effectiveness is assessed. * Participate to technology transfer, scale-up or improvements projects through validation and on-site presence * Identify and timely communicate to the management any supply risk or risk of batch rejection * Solves technical and operational problems in field of expertise based on existing policies, procedures and solutions. * Identify any compliance gap in Biogen processes and identify appropriate stakeholder to fix the issue * Identify and drive opportunities of improvement/standardization in the purpose of continuous improvement of the system/process used * Support as active member of the commercial FG QA compliant and timely progression of changes associated with Launches and routine artwork, safety update etc. *Who You Are * Being a seasoned quality assurance representative you strive for process improvement and change status quo. You are an excellent communicator and are passionate to work in a cross-functional team with focus on compliance and patients. * Minimum, a BS degree in life sciences, engineering or related field preferred. * A minimum of 5 years of experience in pharmaceutical or biotechnology industries * Relevant experience in one or several of the following fields: manufacturing, packaging, development, vendor management, quality or regulatory; * Strong understanding of cGXPs, quality systems and regulations (FDA and EU and subsequent applications to pharmaceutical drug product manufacturing and medical device development. * Knowledge of medical device regulations and unit operations for manufacturing of either Parenterals or Pharmaceuticals, is a plus. * Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams. * Good understanding of CMO mediated Supply Chain activities including process, technology transfer, and routine operations * Strong communication skills * Strong quality mind-set * At ease picking up new IT solutions swiftly *Preferred Skills * MS degree * Ability to work in an international matrix environment. * Negotiation skills * Ability to clearly articulate complex situation into resolution by providing path forward to the upper management * Knowledge of Japanese or other geographies’ regulations *Why Biogen? * Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

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