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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 hygiene, and employee safety.

Ensures quality agreements have been established with external contract laboratories. May serve as point of contact. Supports internal and external audits as necessary. Ensures timely resolution of any audit observations.

Responsible for communicating business related issues or opportunities to next management level For those who supervise or lead 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.

Qualifications:

Education:

A Minimum of Bachelor’s degree is required with a focus in a Technical / Science field, such as Chemistry, Engineering, Materials Science, etc preferred.

Required Skills:

+ 10 to 15 years’ related experience in laboratory operations in the pharmaceutical or medical device industry.

+ Experience in managing budgets.

+ Minimum 5 years’ experience leading professional and technical level associates.

+ Knowledge and experience with chemical and physical testing equipment, such as GC, HPLC, AA, Instron, viscometers etc.

+ Familiarity with basic industrial microbiological techniques.

+ Statistical and analytical problem-solving experience required.

+ Excellent oral and written communication skills.

+ Ability to organize and follow up on multiple priorities.

+ Ability to make decisions which effectively support the business and company policies.

Preferred:

+ Experience with combination and/or pharmaceutical products.

+ Certified Green. Belt or Black Belt.

+ Knowledge of lean laboratory processes.

+ Familiarity with polymer processing and characterization.

**REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS** _._

Interpretation and application of the following standards and regulations: 21CFR 820, 21 CFR 4, 21 CFR 11, ISO 13485, ISO 14971, SOR/98-282, 93/42/EEC, RDC16/2013. FDA, ICH, and other regulatory requirements for applicable good laboratory practices

ADDITIONAL POSITION REQUIREMENTS:

Work in a team environment behaving in a CREDO based manner. Stay in sync with all federally regulated programs. Adheres to J&J environmental and safety policies and guidelines. Follow all job specific safety procedures and use PPE when vital. Follow quality system requirements as defined within procedures and instructions. Use applicable software systems as needed for the job (e.g. ComplianceWire, ADAPTIV, LIMS, etc.) Consistently meet required work performance targets (RE’s), if applicable Support LEAN, Six Sigma, and other business excellence Initiatives. Accurately complete records as defined within the job procedures (e.g. manual and/or electronic documentation). Perform other work-related duties as assigned by supervisor. Consistently meet required Training due date targets.

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.