Senior Manager, Quality Assurance

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We are searching for the best talent for Senior Manager Quality Assurance to join our DePuy Synthes Quality organization located in Palm Beach Gardens FL.

Responsible for the overall management and effectiveness of the key Site Quality Management Systems (Training CAPA and NR) and risk management processes. At this level the position has a greater degree of impact on the business results and typically responsibility for managing a group of professionals.

Key Responsibilities

• Implements the continuous improvement of quality systems to facilitate business and quality objectives and compliance review and resolution processes.
• Alerts the organization to issues in time to resolve potential adverse effects on the customer company image or reputation of the business.
• Leads the Quality team to implement Engineering and Quality Systems and Regulatory Compliance strategies and objectives.
• Develops and leads a team of Quality Engineers to create effective quality engineering processes lead/support strategic projects and assure compliant and efficient execution of manufacturing processes.
• Ensures the Implementation of world-class quality engineering systems to support entire product life cycle with focus on business results including prevention and detection of defects at earliest phase.
• Works with multi-functional teams to establish operational plans and ensures uninterrupted support to manufacturing operations.
• Serves as a consultant in the quality related operations and quality systems applicable to the plant products and processes. Provides guidance and recommendation as needed.
• Provides support on activities documents and records requiring Quality Engineering review and/or approval.
• Leads or aids planning and execution of validation and verification activities.
• Conducts and/or participates in troubleshooting and/or deviation investigation efforts including NC CAPA and complaints.
• Executes Six Sigma / Process Excellence projects to characterize and optimize procedures equipment or processes.
• Collaborate with cross functional partners during the NPI design transfer activities in alignment with business needs.
• Ensures adequate resources with the appropriate proficiencies to execute the Quality System.
• Establishes and monitors metrics for the measurement of Quality Indicators and Financials. Ensures timely escalation and communication of product quality issues or customer concerns per applicable processes.
• Accountable for the development execution and delivery of quality strategies in alignment to the Power Tools and Robotics Value Streams supported by the PBG Site.
• Partner with Value Stream Leaders End to End Supply Chain partners R&D Quality Operations Regulatory & Marketing to assure all NPI quality results are met within cost quality and schedule targets.
• In partnership with other supply chain functions develop Quality capital budget plans and supervises its performance over time including long range planning and adherence to financial commitments.
• In collaboration with other functional partners ensures that programs and projects stay on plan by removing obstacles which may involve negotiations at a senior level.
• Collaborates with the Quality Centers of Excellence and assure execution of business processes at the site level.
• Ensures a customer centric approach and partners with Franchise Quality teams to deliver customer commitments.
• Responsible for the recruitment supervision training and development of Quality personnel.
• Leads/Host FDA/BSI and other foreign regulatory audits to the sites as required.
• Responsible for communicating business related issues or opportunities to next management level.
• For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable
• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures.
• Performs other duties assigned as needed.
  

Qualifications

• A minimum of a bachelors degree is required.
• A minimum of 8 years of experience in Supply Chain Quality and/or R&D within a GMP or ISO regulated industry
• A minimum of 3 years of direct people management experience
• A minimum of 3 years experience in Quality
• Experience hosting Notified Body/FDA audits.
• Experience leading/supporting strategic projects.
• Experience leading Validation/Verification activities including CSV and Test Method Validation
• Experience leading strategic projects within the Medical Device regulated environment.
• Strong knowledge of FDA EU and other Global regulations
• Strong collaboration influencing skills and experience working in a highly matrix environment.
• Strong skills with a proven track record in handling risk-based decision making.
• Proven record of employee engagement change management and ability to drive a strong Quality Culture
• Track record of talent development
• Other Advanced degree or a degree with a focus in Engineering Science Computer Science or Digital area.
• Experience bringing digital capabilities to a Supply Chain environment.
• Capital Equipment Management Electromechanical assembly and robotics/digital manufacturing processes.
• Medical Device experience
• Experience supporting Service and Repair centers for capital equipment.
• Process Excellence or Lean experience
  

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals.

Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via .Internal employees contact AskGS to be directed to your accommodation resource.

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