HireDiversity

North America

GLOBAL ORTHOPAEDICS CAPA MANAGER-CCDP112912

Description

DePuy Synthes, a Johnson & Johnson company is hiring a Global Orthopaedics CAPA Manager. This position can be located in any Johnson & Johnson site globally with a strong preference to the US, Ireland or Switzerland.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

The ideal candidate will provide ongoing strategic review and continuous improvement of the Global Orthopaedic CAPA process in line with Global Orthopaedic and Sector standardization initiatives utilizing robust project management methodologies. The CAPA Manager will ensure the continuous implementation/ improvement of Quality Systems efforts through the CAPA process. S/he will interface with all departments within Global Orthopaedics, J&J Franchise, Sector & Corporate Entities, Notified Bodies, FDA and International.

The Global Orthopaedics CAPA Manager will design, develop and implement standardized procedures, processes and systems for CAPA across Global Orthopaedics. Maintain overall management and effectiveness of the CAPA system including the process and application. Ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to CAPA. Develop and implement measures to monitor the effectiveness of the CAPA system. Ensure results of verification and monitoring of the effectiveness of CAPA and its compliance to applicable regulations and standards of monitoring process are routinely communicated to management. Facilitate Change Management activities resulting from the standardization of the CAPA process and associated systems across Global Orthopaedics. Form and Lead the CAPA Global Orthopaedics working group. Liaise with other management personnel in formulating and establishing Global Orthopaedics policies, procedures, and quality objectives. Liaise with the Global Orthopaedics Quality System Development team to align on system requirements to support the CAPA process. Standardize and leverage MD&D compliance policies, practices, metrics and resources across the sector in alignment with the enterprise standards. Identification and leadership of tactical continuous improvement opportunities. Identify opportunities for procedural harmonization and integration. Identify and establish best practices, ensuring J&J best practices are utilized throughout Global Orthopaedics. Establish Global initiative to develop and deliver best in class education and training for all CAPA users to deliver consistent CAPAs compliant with Global Orthopaedics standards and Medical Device Regulations. Ensure regulatory inspection readiness plans are in place across Global Orthopaedics in preparation for regulatory inspection (internal and external). Act as subject matter expert for CAPA processes to key stakeholders and for external regulatory inspections. Partner on the formulation of responses to regulatory agencies in order to address CAPA related observations. Collaborate in the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions. Provide leadership, oversight and strategic guidance for significant regulatory compliance issues across the operating companies in Global Orthopaedics. Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliation and industry meetings. Support Global Orthopaedics objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure. Carry out strategic planning and development process on a continuous basis, analysis, definition and PMO leadership. Carry out quality system due diligence and integration activities as required by the business. Ensure emerging regulatory requirements are addressed in a proactive and effective manner. Perform financial planning and overall budget management.

Qualifications


A minimum of a Bachelor's degree is required in science, engineering, or equivalent. Advanced degree is preferred. A minimum of 9 years of relevant industry experience is required. A minimum of 5 years management experience in the Quality and Regulatory Compliance in the medical device/ pharmaceutical industry is required. Strong knowledge of quality and compliance in a regulated manufacturing environment (GMPs) is required. Working knowledge of Quality System Regulations is required. Prior experience managing External Regulatory and/or Notified Body Inspections (e.g. FDA, BSi etc.) is preferred. A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement is highly preferred. Experience in auditing to FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards is highly preferred. Demonstrated knowledge of business impact of compliance issues and risk management is required. Demonstrated effective people management in multiple locations is required. Experience in preparing for & managing external third party audits in multiple locations is required. Process Excellence Black Belt Certification is preferred. Strong compliance management track record is required.

This position can be located in any Johnson & Johnson site globally with a strong preference to the US, Ireland or Switzerland. Up to 30% travel globally is required.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America
Other Locations:Europe/Middle East/Africa-Ireland, Europe/Middle East/Africa-Switzerland
Organization: Depuy (Ireland) Limited (7386)
Job Function: Quality (Eng)