Manager Quality Systems

Manager Quality Systems

The Manager of Quality Systems for North America will develop, establish and maintain efficient quality systems, ensuring that performance conform to established standards and agency guidelines and to drive alignment and continuous improvement across regional sites. Continuously stays current on changes to regulations and guidance as well as industry trends. Provide guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance and alignment across facilities. Establishes the framework for Quality Management Review. Manages the Data Integrity Program. Establish and ensure appropriate Quality Systems are maintained which allows sites to have ongoing data analysis of product and process outputs to ensure early detection and response to quality concerns, and prevention of quality issues. Manage and oversee aspects of the Quality Management System (QMS) including but not limited to investigations, CAPA, change control, internal audit, training, and stability program. The Manager of Quality Systems is responsible for ensuring accountability, transparency, and effective communication cross-functionally and within their team while ensuring information is timely, clear and accurate. By coaching and developing their team to High Performance, will foster a team ownership culture that ensures compliance with all Corporate and Local policies, procedures and regulations. In addition, the Manager of Quality Systems must supply the highest level of both internal and external customer service and collaborate with various functional groups. To effectively recognize and reward performance, the manager must measure and communicate the team's progress against individual, team and site goals and Key Performance Indicators (KPI's).

Bachelor Degree in or Life Science required. Advanced degree preferred. Twelve or more years of progressively increasing Quality pharma experience to include Quality Systems, with two or more years in a leadership role required; (preferably managing multiple sites or multi-shift). Radiopharmaceutical experience preferred. Expert knowledge of cGMP requirements, specific to Pharmaceutical and/or Chemical industry experience required. Expertise in the manufacture and control of finished sterile injectable products, analytical analysis techniques and statistical quality control. Strong working knowledge of US and international requirements and guidance documents. Thorough understanding of Quality systems. Ability to use relevant software packages to process and analyze data. Prior experience managing inspections performed by US and international Regulatory Authorities. High level of proficiency in Microsoft Windows and Office Suite (Word, Excel, Power Point and Access), advanced computer skills. Lean / Kaizen / Six Sigma experience preferred. Experience working with High Performance Teams preferred. Cross-functional experience preferred. Experience with developing/documenting procedures preferred.