Director, Development Quality Assurance (Operations)

Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of innovative therapies designed to treat cancer and immune-inflammatory related diseases in patients with limited treatment options.

This position is responsible for the direct oversight of all Quality GMP operational activities pertaining to the manufacture, packaging, labeling, distribution and release of Clinical Supplies in accordance with Celgene policies, procedures and GMPs. The incumbent will oversee all aspects of product quality produced by Contract Service Provider (CSPs) and will report to the Executive Director of Global Quality Assurance, Development. The incumbent’s leadership will provide an environment that promotes and maintains a collaborative culture. Working as a key member of the Development Quality Assurance team, the candidate will proactively recognize and address any policy issues associated with the product quality or suitability for its intended use.

* Responsible for the direct oversight of Vendor Quality Managers and a team of Batch Record Reviewers within the Development QA department. * Directly oversees release function of materials produced at contract manufacturing, packaging and distribution sites for investigational materials to ensure that Clinical Supplies are produced in accordance with all Celgene policies, procedures and GMPs. * Will be the Quality interface with the Investigational Material Supply Chain department ensuring alignment of strategic and operational plans. * Accountable for ensuring that the work performed by the Development Quality Operations team is accurate, timely, efficient and compliant with applicable regulations. * Charged with identifying strategic and operational issues, developing proposals, outlining solutions, and negotiating time commitments and resources in support of the Development Quality Operations unit. * Development of corporate infrastructure to allow for efficient execution of batch disposition. * Development and management of Quality Operations organization: * Hire and train team members to develop the second line of management. * Instill a proactive culture and “can-do” attitude for all employees and to challenge them to volunteer new ideas resulting in increased operational efficiencies. * Build trust and create a collaborative environment. * Motivating team member to be leaders.

**Skills/Knowledge Required:** * At least 14 years experience in pharmaceutical companies or related industry * At least 10 years experience in pharmaceutical operations including manufacturing, packaging and labeling. * A minimum of 5 years experience in Quality Assurance Operations functions. * Thorough knowledge of the Pharmaceutical Development Process. * Thorough understanding of the GMPs as related to Clinical Manufacturing. * Understanding of Health Authority expectations relative to CMC Development as well as Clinical Trial supplies. * Knowledge of required QP processes for Investigational Materials and expectations for International markets. * Good working knowledge of CMC Regulatory affairs. * Contract Service Provider Contract management experience * Ability to forge cross-functional partnerships and strategies. * Demonstrated skills in project management and handling multiple projects simultaneously * Demonstrated teamwork and collaboration skills **Education and Experience** * A minimum of a BS degree (advanced degree highly preferred) and 14 years of relevant experience covering functions such as manufacturing operations, clinical supply chain and Quality Assurance activities for development programs. Periods spent within the Quality organization at a Production Center would be considered an advantage.