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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:

Project/Program Management Group

Job Sub** **Function:

Project/Program Management

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine .

We are searching for the best talent for Operations Support Lead to be onsite in Athens, Georgia! An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Are you interested in joining a team that is helping improve patient care and drive innovation? At Johnson & Johnson, we blend heart, science, and ingenuity to profoundly change the trajectory of health for humanity. Apply today for this exciting opening to support us at our pharmaceutical plant!

The Operations Support Lead plays a vital role overseeing the Johnson & Johnson Innovative Medicine (JJIM) Operations Investigation program under the guidance of the Operations Support Manager. The Lead is responsible for ensuring the implementation of operational processes and providing technical expertise to facilitate investigations, corrections, and corrective and preventive actions (CAPAs) in compliance with cGMP requirements and FDA regulations. They lead and coordinate the Operations Investigation team’s activities, providing support, guidance, and continuous monitoring/feedback. The Lead will collaborate closely with the Quality Unit to ensure investigations meet regulatory requirements and internal standards. They will continuously monitor and provide feedback to drive process improvements to ensure site metrics are met. They complete investigations, root-cause analyses (RCAs), and determine appropriate corrections and/or CAPAs for non-conformances (NCs) and associated documents in the quality management system (QMS). They will also lead the capability building for complex problem solving for the site. Through their leadership and technical acumen, the Ops Support Lead will help maintain a compliant, efficient manufacturing environment and support ongoing site-wide operational and quality excellence.

KEY RESPONSIBILITIES:

+ Provide leadership and guidance to the Operations Investigation team to ensure that robust in-depth investigations are performed, causes of non-conformances are identified and understood, and that effective corrective/preventive actions are implemented.

+ Monitor the investigation team activities to ensure resources have been adequately assigned to meet site metrics.

+ Perform investigations and document in the QMS.

+ Analyze data, determine trends, and implement actions for process, equipment and system improvements.

+ Review the effectiveness of previously implemented actions to determine if additional actions are needed.

+ As necessary, write procedures, protocols, and any other documentation needed for the enhancement of processes and systems.

+ Participate, lead, and/or assist in cross-functional investigations and Root Cause Problem Solving (RCPS).

+ Provide training and education to the team on complex problem solving, analytical trouble shooting, and statistical concept application.

+ Communicate investigation related issues, trends, or opportunities to site management.

+ Establish an effective follow-up mechanism or system to monitor that investigation activities are adequately and consistently addressed, and reports are issued and completed timely.

+ Communicate periodically with functional areas to review and inform the result of the monitoring and trending evaluations to provide feedback on the effectiveness of the appropriate actions or demand commitments/accountability to further prevent recurrence.

QUALIFICATIONS:

EDUCATION:

+ Minimum of a High School or equivalent diploma is required; Bachelor's or equivalent degree and/or focused degree strongly preferred

EXPERIENCE AND SKILLS:

Required:

+ Minimum 4 years of relevant work experience

+ Work experience in a chemical, pharmaceutical, biotechnology, medical device, or cGMP or similarly regulated manufacturing industry

+ Experience with complex problem solving, investigations, and data analysis

+ Ability to lead and influence teams without direct authority

+ Ability to learn and operate quality management and training systems

+ Ability to respond to sensitive inquiries and present information to Site Management, regulatory agencies and members of the business community

+ Ability to define problems, collect relevant data and information, establish facts, and draw valid conclusions as required

+ Manage and coordinate multiple project priorities as required

+ Ability to work independently on routine and non-routine tasks

+ Solid understanding of Word, Power Point, and Excel

Preferred:

+ Experience with Minitab, JMP, or other statistical software

OTHER:

+ Requires proficiency in English (to read, write, and understand) to effectively interpret documents such as safety rules, operating and maintenance instructions, government regulations, and procedure manuals

+ Requires ability and willingness to move around the manufacturing plant to perform on-site investigations

+ Requires ability to perform and adhere to gowning procedures to work in manufacturing core

+ Requires ability to work onsite primarily during day shift hoursand work alternate/off-shift /on-call depending on business needs or emergency basis

+ May require up to 10% domestic and/or international travel

+ Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position

_\#LI-Onsite_

_Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act._

_Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via_ _https://www.jnj.com/contact-us/careers_ _, internal employees contact AskGS to be directed to your accommodation resource._

Required Skills:

Preferred Skills:

Agility Jumps, Analytics Insights, Business Alignment, Coaching, Communication, Cost-Benefit Analysis (CBA), Cross-Functional Collaboration, Monitoring, Evaluation, and Learning (MEL), Persistence and Tenacity, Problem Solving, Process Oriented, Project Management Methodology (PMM), Project Management Office (PMO), Project Management Tools, Project Reporting, Statement of Work (SOW)