11 days old

Director, Medical Device, Quality Control Laboratories, North America/ Latin America Lead

Johnson & Johnson
Somerville, NJ 08876

The Johnson & Johnson Medical Devices Companies are currently hiring for a Director, Medical Device, Quality Control Laboratories, North America/ Latin America Lead to be located in Athens, GA, Cornelia, GA, Somerville, NJ, San Lorenzo, Puerto Rico, San Angelo TX, or Irving, TX.


The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.


The Director MD QC Laboratories is a regional hub leader for the North American and Latin American teams of Quality control laboratories. The Director MD QC Laboratories NA/LA Lead reports directly to the Senior Director MD QC Laboratories. This position acts as the single point of contact for laboratory leads and stakeholder interfaces in the region and is responsible for overall laboratory operations. In addition, this leader will manage capabilities within the regional hub (i.e., people, processes and technology) and assesses potential synergies and capacity optimization. May perform as a delegate to the Senior Director Quality Control Laboratories.


Responsibilities:

  • Strategic development and successful execution of QC testing and operating strategies for existing and new product portfolios.
  • Maximize the efficiency and effectiveness of the QC laboratory operation.
  • Implement new technologies and processes that take forward strategies to maximize productivity and reduce testing cycle time.
  • Partner effectively with R&D and MAKE to embed quality control in our supply chain processes, such as PAT (Process Analytical Technologies) and DTV (Design to Value)
  • Partners with local and regional site staff and stakeholders (R&D, Make, Source, BQ, QA, etc) and is accountable for the implementation and maintenance of key performance indicators/ metrics. Ensures that production and quality levels meet or exceed organization and customer expectations.
  • Ensures alignment of regional hub with MD QC laboratories Global Laboratory Capability Centers (GLCC) as required. Works with peers and other QC leaders to deploy and embed harmonized processes through the GLCC.
  • Develops and deploys cost competitiveness focus and ensures the culture of continuous improvement of business performance is strong
  • Working with GLCC, ensures scalable and flexible capacity utilization, utilizing both internal and external laboratory capabilities to address changes in demand
  • Manage escalation of issues or testing interruptions in conjunction with the local QC lead and site QA
  • Ensure strong budgetary CAPEX and OPEX management
  • Responsible for communicating business related issues or opportunities to next management level
  • Ensure a clear talent development strategy is implemented enabling career development, both technical and people leadership. Ensures building of new capabilities for the new product pipeline
  • People management of a globally-dispersed diverse staff and related stakeholders in quality activities to optimize favorable outcomes and ensure balanced decision-making. Fosters organizational development. Creates and drives a high level of commitment to customer service.
  • 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
  • Develops and manages budget, organizational structure and business requirements / metrics to accommodate business needs
  • Performs other duties assigned as needed

Qualifications
  • A Bachelor’s degree (or University equivalent) is required, preferably in a field of study includes life sciences. An advanced degree in life sciences or business preferred.
  • A minimum of 10 years relevant experience, including 5 years laboratory management experience is required
  • In-depth understanding of medical devices processes and manufacturing, and GMP requirements is preferred
  • Proven experience in dealing with internal & external stakeholders, both regulatory stakeholders as well as external business partners. Good knowledge of international regulatory requirements and agencies is preferred
  • Demonstrated knowledge of GxP regulations and proven cycle of success in implementing and maintaining GMP compliance required
  • Strong interpersonal partnering capabilities with a focus on customer service and delivering results with the ability to build and nurture strong and positive relationships with Therapeutic Areas, Commercial and R&D leadership. Ability to communicate across all levels of the organization is required
  • Demonstrated business skills, including financial acumen and business planning with previous experience with budget and capacity planning (OPEX, CAPEX, headcount) is required
  • Demonstrated experience in delivering business improvements projects is required
  • Ability to translate strategy to execution for local laboratories to ensure ability to achieve business results is preferred 
  • Ability to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile and rapidly changing environment is required
  • Knowledge of the business environment inside a quality organization across various roles is preferred
  • Certification in Lean/Six Sigma is preferred
  • This position will be located in Athens, GA, Cornelia, GA, Somerville, NJ, San Lorenzo, Puerto Rico, San Angelo TX, or Irving, TX and may require up to 25% domestic and international travel
 

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.



Primary Location
United States-New Jersey-Somerville-
Other Locations
North America-United States-Georgia-Athens, United States-Georgia-Cornelia, United States-Texas-Irving, United States-Texas-San Angelo, United States-Puerto Rico-San Lorenzo
Organization
Ethicon Inc. (6045)
Job Function
Quality Control
Requisition ID
9998181214
Posted: 2019-01-04 Expires: 2019-02-03

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Director, Medical Device, Quality Control Laboratories, North America/ Latin America Lead

Johnson & Johnson
Somerville, NJ 08876

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