Director, Quality Assurance

This position is responsible for the operational aspects of the Quality Assurance group, which includes the In-process Inspections & Batch Records Review group, Label Control & In-coming Materials group. This responsibility includes, but is not limited to, the effective planning and organization of personnel and workflow utilization in order to support manufacturing activities and release of finished goods in accordance with all policies, procedures and regulations governing the manufacture of Pharmaceutical products. The individual is responsible for providing quality oversight for the manufacturing process by managing, coordinating and controlling the quality assessment of raw materials, packaging components, in-process and finished goods. Takes leadership role in directing the operational activities of the QA In-process Inspection group, In-coming Material Receipt and Label Control group and Finished Product Release group to ensure effective planning and organization of personnel and workflow utilization for efficient support of manufacturing operation. Maintains presence on the floor during manufacturing and provides guidance as to the resolution of issues potentially impacting the quality of the product.

•Establishes and maintains Quality Assurance programs, procedures and controls. Ensures the performance and quality of products conform to the established company and regulatory standards.
•Manages and directs the activities of the Label Control & In-coming Materials group.
•Manages and directs the activities of the In-process Inspections & Batch Records Review group.
•Reviews the departments SOPs and other procedures and initiates changes and/or improvements, where necessary, to keep up with current industry and regulatory standards.
•Perform QA review and approval of SOPs, protocols, task reports, change control and product masters as required.
•Competency in the core technical skills relating to Quality/Compliance functions in the Pharmaceutical Industry.
•Maintains presence on the floor during manufacturing and provides guidance relative to the resolution of issues potentially impacting the quality of the product.
•Assume leadership role for specific, defined responsibilities as deemed necessary by the department head.
•Interact with manufacturing, quality control and other manufacturing support departments to perform root cause analyses and identify corrective/preventive actions.
•Assists Senior Director, QA and Compliance with all regulatory inspectional activities.
•Carries out supervisory responsibilities in accordance with Cephalon’s policies and applicable laws. These responsibilities include interviewing, hiring, and training of employees; planning, assigning, and directing work; appraising performance, addressing complaints and resolving problems.

To perform this job successfully, this individual must be able to perform each primary responsibility satisfactorily. The requirements listed are representative of knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The individual must have a minimum of a Bachelor’s Degree in Science or Engineering with at least 10-15 years of QA experience in the Pharmaceutical or related industry, including 5 + years in a managerial capacity. Demonstrated ability to develop solutions to technical, relational and organizational issues to effectively gain agreement and support across functional groups. Experience with SAP, Track Wise and other Quality System tools. Good decision making skills and ability generate collaboration and teamwork. Strong written and verbal communication skills, organizational, leadership and mentoring skills are essential. A thorough understanding of the FDA/European GMP regulations and compliance is a must.

If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=499875-3-263