Senior Manager, Quality Assurance

Johnson & Johnson Innovative Medicine•Palm Beach Gardens, FL

1d•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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.

Requirements

A minimum of a bachelor’s 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

Nice To Haves

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

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.