MANAGER, ESCALATIONS & FIELD ACTIONS

Johnson & Johnson Vision a member of Johnson & Johnson Family of Companies is currently recruiting for a Manager for Escalations and Field Actions.
This position can be located at either of our Johnson & Johnson Vision Sites in Irvine, CA or Jacksonville, FL! 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.
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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
This role is responsible for establishing and maintaining effective Escalation and Field Action Processes and Applications/Platforms that are in compliance with local, national and international regulations and standards as well as with all franchise policies and processes and J&J Corporate requirements.
You will facilitate and prepare for Issue Escalation RMB and Quality Review Board Meetings by managing the process oversight with investigators for gathering of required information from all sites/required groups, performing dry runs, preparing minutes, following up on action items and maintaining records as well as coordinate, follow-up for RMB and QRB meetings and maintain related files.
Manage field corrective actions, any associated regulatory actions and follow-ups including support to field action coordinators globally; assist in product problem resolution as part of follow-up from QRB and CAPA.
Track all activities associated with the escalation process to assure compliance with all applicable policies and procedures, including.
Responsible for the coordination of field action activities including preparing documentation for recordable and reportable field actions.
Track customer communications for effectiveness verification.
Complete interim status reports to the FDA at the required intervals.
Prepare and maintain electronic and hard copy recall files.
Prepare or assist leadership with monthly reports.
Lead or participate in process improvement projects.
Responsible to identify and execute strategic programs and projects to elevate systems and foster innovation.
This role monitors the performance and health of the associated Quality Management Systems elements through metrics and analytics to drive enhancement and proactive compliance.
Supports departmental and business unit objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
Key Responsibilities.
Accountable for maintaining department compliance with regulations such as, but not limited to, FDA Quality system Regulation 21 CFR Parts 820; ISO , FDA Combo Regulation 21 CFR Parts 4; Current Good Manufacturing Practice (CGMP) regulation 21 CFR , and international regulatory requirements (Japanese MHLW, Brazilian ANVISA).
Provide ownership and leadership of processes and platforms across JJV.
Accountable to establish and maintain effective processes to assure that personnel within assigned business are equipped with the knowledge, understanding and training to successfully execute their responsibilities to the highest of standards.
Actively engages and drives collaboration across JJV, MedTech and Enterprise.
Monitor and identify trends and take corrective action as appropriate to maintain a high level of compliance.
Develop initiatives are focused and aligned with the organizational goals & objectives.
Acts as subject matter expert, identifying areas of improvement and making recommendations that positively impact the QMS.
Qualifications Education.
A minimum of a Bachelor’s or equivalent University degree is required, with a focus in Science, Engineering or Business preferred.
Experience and Skills.
Required.
Minimum six (6) years related experience in Quality, Regulatory, Supplier Quality, or a regulated industry.
Thorough knowledge of 21 CFR 820 and ISO at a minimum.
Working knowledge of international medical device quality system requirements.
Demonstrated ability to handle multiple projects and discern major quality issues.
Knowledgeable of a broad set of regulations and standards (e.
., 21 CFR ; ISO ; etc.).
Skills.
Detail oriented, people leader, quick learner, team player.
Abilities.
Critical thinking, strong communication and negotiation skills, ability to lead others.
Preferred.
Proven track record and strong leadership capabilities.
Ability to effectively manage people (both directly and indirectly) and manage projects that include cross-functional teams representing diversified areas.
Demonstrated success in leadership development.
Direct supervisory responsibilities for a department or function.
Other.
This position will be located in either Irvine, CA or Jacksonville, FL and may require up to 10% domestic or international travel.
The anticipated base pay range for this position is $ to $.
– The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs.
medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits.
– Vacation – up to 120 hours per calendar year – Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year – Holiday pay, including Floating Holidays – up to 13 days per calendar year – Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to.
https://www.
areers.
nj.
om/employee-benefits This job posting is anticipated to close on August .
The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om to accept additional applications.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
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