HireDiversity

Zuchwil, CH

Europe CAPA Manager-000008XL

Description

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.

JOB PURPOSE:

Support the DePuy Synthes WW CAPA Manager providing ongoing strategic review and continuous improvement of the CAPA process in line with DePuy Synthes and Sector standardization initiatives utilizing robust project management methodologies. The EU CAPA Manager will ensure the continuous implementation/ improvement of Quality Systems efforts through the CAPA process.

• Support the design, development and implementation of the standardized procedures, processes and systems for CAPA across Global Orthopaedics.
• Maintain overall management and effectiveness of the CAPA system including the process and application for the EU region.
• Ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to CAPA.
• 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, within EU region, resulting from the standardisation of the CAPA process and associated systems across Global Orthopaedics
• Liaise with WW CAPA Manager in establishing and implementing DePuy Synthes policies, procedures, and quality objectives.
• Liaise with the WW CAPA Manager 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.
• Deliver best in class education and training for all CAPA users to deliver consistent CAPAs compliant with DePuy Synthes standards and Medical Device Regulations
• Ensure regulatory inspection readiness plans are in place across Europe 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.
• Support DePuy Synthes objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure.
• 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 all other work related duties
• Represent Quality as required on quality and business teams throughout Global Orthopaedics, MD&D and J&J Enterprise.

Qualifications


KEY COMPETENCIES REQUIRED:

• Demonstrated leadership ability
• Excellent communication skills, to quickly build credibility within the Quality and Compliance community, executive management, external regulators, and industry - Both verbal and written
• Strong collaboration and influencing skills to partner effectively with Sector functions and across Operating Units - Both Internally and Externally
• Team building and development capabilities
• System design and management skills - Organizational and Quality Systems
• Expert knowledge of the US Quality System Regulations and ISO 13485
• Demonstrated track record of delivering best in class results in the Quality Systems area

QUALIFICATIONS & EXPERIENCE

ESSENTIAL:

• A minimum of a Bachelors degree is required in science, engineering, or equivalent is strongly preferred.
• A minimum of 5 years of relevant industry experience in the Quality and Regulatory Compliance in the medical device/ pharmaceutical industry.
• A minimum of 5 years management experience.
• Strong knowledge of quality and compliance in a regulated manufacturing environment (GMPs).
• Working knowledge of Quality System Regulations.
• 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
• 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
• Demonstrated knowledge of business impact of compliance issues and risk management
• Demonstrated effective people management in multiple locations
• Experience in preparing for & managing external third party audits in multiple locations
• Proven ability to build partnerships both internally and externally

DESIRABLE:

• Post Graduate Qualification in Quality / Regulatory preferred
• Process Excellence Black Belt Certification
• Strong compliance management track record

AD CODE: J2W: JOBSCH

Primary Location:Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil
Organization: Medos Sarl (8575)
Job Function: Quality Systems