Senior Quality Operations Manager

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.

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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America, Cornelia, Georgia, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Quality Operations Manager! This position can be located in Cornelia or Athens, Georgia.

Position Summary:

Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates. At this level, the position has a greater degree of impact on the business results and typically, responsibility for managing a group of professionals.

Implement and lead the quality operations organization for the Ethicon Cornelia, Georgia site by:

• Planning, coordinating, and directing quality assurance programs designed to ensure continuous production of products consistent with established standards
• Serving as the Quality Operations Site Lead and overseeing day-to-day quality operations
• Verifying that the Quality System in in place and maintained at the required compliance level
• Driving Quality System efficient execution and reduced risk of non-conforming product

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:
• Establishes and maintains quality assurance programs, procedures, and controls.
• Ensures that performance and quality of products conform to established company and regulatory standards.
• Analyzes data sources significant quality trends and recommends actions as needed.
• Reviews and approves non-conformances, CAPA, Audit Observations, Change Controls, Validations and Completion Reports, and other quality system documents or records as required.
• Manages the qualification and validation for all products and processes and quality control support activities.
• Supports investigation, evaluation, and implementation of actions to eliminate root causes of non-conformances
• The individual has the necessary independence, authority, and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality issues, initiate, recommend, provide and verify so9ltions.
• Ensures effective risk management process is implemented to prevent unanticipated failure.
• Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems.
• Formulates and maintains quality control objectives and coordinates objectives with preproduction and production procedures in cooperation with other manufacturing managers to maximize product reliability and minimize costs.
• Ensures all such products meet and/or exceed company and local government standards.
• Participates in auditing of production areas and systems.
• Reviews reports findings and makes recommendations for corrective action.
• Submits and administers budget schedules and performance standards.
• Supports and manages cost improvement projects.
• Acts as back up to QA Director for signature authority and meeting representation.
• Responsible for Succession Planning, Goals and Objectives, and Salary planning for direct