Senior Manager, Laboratory Operations

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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

People Leader

All Job Posting Locations:

Cornelia, Georgia, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Manager, Laboratory Operations! This position will be located in Cornelia, GA. Re-location funding is available for this role.

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 https://www.jnj.com/.

JOB SUMMARY:

Responsible for leading and coordinating the activities of the laboratory professional staff, scientists, and technicians engaged in testing and inspecting products and raw materials in order to ensure compliance and production schedules.  At this level, the position has a greater degree of impact on business results and responsibility for leading a diverse group of associates.

DUTIES & RESPONSIBILITIES

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

Plans, coordinates, and advises laboratory actions crafted to ensure continuous flow of testing while meeting safety, quality, delivery, and cost requirements. Ensures compliance to all applicable internal and external regulatory requirements Administers available resources to achieve a reliable, efficient and productive operation.

Using a thorough familiarity with the requirements of US regulations for the manufacture of medical devices, the ISO standard (ISO 13485), and the EC Medical Device Directive, provide compliance education for the facility in support of overall educational strategies.

Ensures all laboratory equipment is properly qualified, calibrated, and preventative maintenance programs established.

Develops and handles implementation of methods and procedures for inspection, testing and evaluation. 

Assures that there are adequate resources, instruments, and supplies to meet business needs.

Assures that instruments used in the test methods are calibrated, maintained and operating properly. 

Evaluates new and existing documentation and test methods. 

Responsible for validating, transferring, and recommending changes to test methods as required.  Reviews and approves laboratory investigations, collaborating with others as needed.  This may include developing investigative protocols and evaluating and documenting results.

Makes recommendations regarding ways to improve laboratory processes and increase product quality and delivery while reducing operating costs. Mentors, coaches, trains and develops the laboratory staff. Evaluates performance, formalizes development plans, and provides opportunities for growth. Communicates department objectives and metrics and measures results. Participates in planning and implementing changes in laboratory methods, instruments and equipment, space allocations, workforce utilization, testing schedules, lines and other factors required to maintain or improve compliance with quality standards of existing products.

Develops and implements detailed and effective processes to investigate and resolve laboratory performance issues. Leads the development and implementation of metrics and systems to measure and guide improvements to product and system quality and customer satisfaction.

Prepares quality control reports, requirements and other information in response to requests for proposals, quotes and other business opportunities. Prepares, handles, and administers budget. Approves OT, timecards, etc. Develops and drives cost control initiatives. Monitors good housekeeping practices, employee