Manager, Compliance

Stryker is an exceptional company with exceptional people who deliver exceptional results. We have differentiated ourselves by advancing meaningful innovations, creating cost-effective solutions for and improving the lives of our global customers and patients. As a winner of the 2007 and 2008 Gallup Great Workplace Award, we have demonstrated that Stryker has one of the most productive and engaged workforces in the world. Our exceptional results fuel ongoing opportunities for Stryker employees to build outstanding careers and to develop and grow both personally and professionally. Our work environment attracts many different kinds of talented and driven people who love to win and serve others. We always put quality first. We hold ourselves accountable to reach or exceed our goals and continually improve everything we do. These attributes are shared by the employees that make up Stryker. They are the things that bring us together and serve as the foundation of all we do. And they are the enablers of both our past and future success.

Stryker is one of the world’s leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at: http://www.stryker.com

The Manager, Compliance is responsible for the systematic review and auditing of the division s Quality System to meet the needs of the company s Quality Policy and objectives as well as compliance with national and international regulations. This position has responsibility for performing both Internal and Vendor Audits. In addition, the position supports the monitoring of vendor performance and analysis and activities related to the Vendor Surveillance Program.1. Help create and maintain GLP and GCP compliant processes, including qualification of CROs, investigator site audits, GLP phase audits and report review2. Perform internal Quality audits per the established schedule and report results to management, especially focused on Sales and distribution processes. 3. Perform vendor Quality audits per the established schedule and report results to management, where needed. 4. Assist in the ongoing evaluation and analysis of all vendors from a Quality perspective.5. Maintain up-to-date working knowledge of national and international standards and guidelines as these relate to GCP and GLP.6. Other duties as assigned.Bachelor s degree in a scientific discipline, plus minimum of 7-10 years of quality assurance experience in a (bio)pharmaceutical company. Working knowledge of CFR (and equivalent EU) requirements as these apply to GLP, QSR, GCP and GMP, as well as ISO 13485:2003 and ICH E6 (for GCP). Knowledge / audit experience in GMP a plus. Excellent communication skills, both oral and written including the ability to negotiate and influence others. Must have extensive auditing experiences (esp. GCP and GLP), with certification (e.g. Lead Auditor, CQA) highly desirable. The ideal candidate is self-motivated with the ability to initiate and follow through on assignments with minimal supervision.See QualificationsStryker is an equal employment opportunity/affirmative action employer committed to hiring a diverse workforce.To read more about Stryker, please visit our website at www.stryker.com