\\n DePuy Sythes is recruiting for a Senior Manager, Quality Systems, located in Zuchwil, Switzerland. Other DePuy Synthes (DPS) locations will be considered.

You will lead the DePuy Synthes Quality System processes and organization by:

• Ensuring the DPS processes are effectively maintained achieving a state of compliance across all DPS sites.
• Providing management with timely and comprehensive quality data that supports analysis and product and process improvement decisions.

Key Responsibilities:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:

• Leads the business execution of Quality System processes in DPS including (but not limited to): NC, CAPA, QPR, QSMR, Audit support, ICQA, and Quality Certificates.
• Coordinates the appropriate governance activities to assure adequate analyses, risk assessment and corrective/preventive actions are taken to mitigate product and process risk.
• Provides active link and partnership with J&J Sector, Enterprise, and QS/DS COE partners, as well as the manufacturing sites and franchise locations.
• Monitors related DPS business metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness.
• Provides coaching on Quality Management System processes to DPS sites as necessary.
• Ensures the appropriate level of qualification in the Quality Management System processes by business partners to support driving actions and timely metrics.
• Supports in the initiation, investigation, evaluation, implementation of actions and approvals of nonconformances and corrective/preventive actions.
• Leads all aspects of DPS Review Boards and Quality System Management Reviews, including preparing, hosting and tracking action items, to ensure appropriate and consistent actions are being taken in response to Quality System triggers.
• Assures Quality Management System processes are in compliance with regulatory requirements. Supports audits and acts as a subject matter authority as needed and supports the adjustment of the processes in response to compliance trends or actions.
• This individual has the necessary independence, authority and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product.
• Responsible for communicating business related issues or opportunities to next level management.

Experience and Skills:

Required:

Eight (8) years of experience in the Pharmaceutical, Medical Device or Biologics industry with managerial experience required; or an equivalent combination of education and experience. Expert knowledge of the US Quality System Regulations and ISO 13485 is required. Solid understanding of ISO 14971 and the Quality System Regulations is required. Strong knowledge of CAPA, quality and compliance in a regulated manufacturing environment (GMP/ISO) is required.
Preferred:

• Experience owning & driving Quality system processes strongly preferred
• Working knowledge of related functions such as Product Development, Operations, Supplier Management and Procurement is preferred
• Demonstrated experience in successfully collaborating across functions and delivering business results
• Strong documentation skills and technical writing capability.
• Experience in supporting health authority and or Notified Body inspections.

Other:

20% potential travel for domestic, international, or both.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .]\\n \\n \\n \\n \\n \\n

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