World Wide Clinical Quality Assurance Manager
DePuy Products, a member of the Johnson Johnson family of companies is looking for a World Wide Clinical Quality Assurance Manager for the Raynham, MA facility.
The DePuy Family of Companies has a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care. These companies are unified under one vision - Never Stop Moving - to express their commitment to bring meaningful innovation, shared knowledge and quality care to patients throughout the world. DePuy Orthopaedics, Inc., DePuy Spine, Inc., DePuy Mitek, Inc., and Codman Shurtleff, Inc. develop and market products for reconstructing damaged or diseased joints; repairing and reconstructing traumatic skeletal injuries; facilitating the treatment of spinal disorders and deformity; repairing soft tissue in the shoulder, knee and other joints through minimally invasive means; and surgically treating neurological and central nervous system disorders. DePuy has three main locations: Warsaw, Indiana and Raynham, Massachusetts in the U.S. and Leeds in the UK.
The World Wide Clinical Quality Assurance Manager will be responsible for maintaining a Clinical Quality Assurance program for the DePuy Franchise (DePuy Spine, DePuy Mitek, DePuy Orthopeadics and Codman Shurtleff). This position will manage the activities required to assure compliance with applicable local government regulations and industry accepted standards that govern clinical studies. The ideal candidate will provide oversight in all activities leading to or potentially leading to a regulatory filing, Biologic License Application, New Drug Application, FDA-mandated post market studies, CE-marking. S/he is responsible throughout the clinical development process, from design of the protocol to the final clinical study report to insure compliance with applicable governmental regulations as well as company policies and procedures.
Responsibilities include all aspects of Clinical Compliance for the DePuy Franchise including but not limited to: Conducting QA inspections/audits/reviews of clinical trials to assure adherence to corporate policies, internal standards/requirements and compliance with regulatory requirements; Auditing sponsor and investigator sites for essential documents required by regulations; Auditing contract research organizations (CRO's), central laboratories, and other specialist facilities; Providing leadership in the alignment of the clinical departments with the clinical quality strategic plan and program priorities; Contributing to the on-going development of the clinical quality program for the franchise, including consistent performance targets and metrics, setting a standard of compliance, measuring and improving clinical compliance internally and externally with our clinical sites and disseminating best practices; Review of study protocols and related study documentation (e.g., CRFs and informed consent forms); Preparation for and hosting regulatory authority inspections.
Additionally, the World Wide Clinical Quality Assurance Manager will also be responsible for working with consultants and executive leaders to identify key industry compliance trends affecting clinical studies and developing recommendations to address those trends. Developing strong working relationships with all Clinical departments across the franchise to ensure effective implementation of the program is key. Developing and implementing communication strategies that inform, link and bond franchise Clinical management with CQA to facilitate information exchange. S/he will also lead development and implementation of a standard set of training requirements for Clinical associates.
Qualifications
A BA/BS in a technical or scientific discipline is required. Minimum of 10 years progressive experience in Clinical, Regulatory Affairs or Quality within the Medical Device, pharmaceutical or other FDA regulated industry is required. Previous experience managing projects is required. Knowledge of FDA Code of Federal Regulations, ICH GCP guidelines and the Clinical Research process preferred.
Previous experience with health authority inspections required. Excellent verbal and written communication skills are required. Organizational skills and the ability to multi-task in a fast-paced environment are required. S/he must have a demonstrated track record in fostering collaboration and building consensus to achieve collective objectives. This position is based in Raynham, MA and requires up to 30% domestic and international travel.
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