MANAGER, PRODUCT QUALITY VIGILANCE - POST MARKET REPORTING

Janssen Pharmaceutical Companies, of the Johnson & Johnson family of companies, is currently recruiting for a Manager, Product Quality Vigilance - Post Market Reporting! This position will be located in Horsham, PA or Titusville, NJ.
Join our growing team! 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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Position Summary The position is responsible for the execution and oversight of PQV activities related to malfunction determination and reporting for Combination Products in conformance to current standards and procedures, using applicable system application tools.
Leads a staff of professionals who execute the process, ensuring all complaint and Medical Device Reports (MDR) timelines are met and critical issues are prioritized.
Participates, directly and indirectly, in regional and global department initiatives, and project teams, to develop, consolidate and/or improve PQV, reporting and related processes.
Represents process with internal auditors and external regulators.
This role will conduct regulatory impact assessments of global combination product regulations and implement f global post market surveillance processes for clinical and commercial combination products.
This role collaborates with peer Senior Managers and Managers in PQV Combo to ensure flawless process transitions and aligned decision making.
Responsibilities Assess new and updated combination product regulations from global health authorities for impact to commercial and clinical portfolio and implement processes for compliance Coordinates the timely determination of device malfunctions and the filing of device malfunction reports related to combination products.
Serves as a subject matter authority for risk management practices, malfunction determination and medical device reporting.
Collaboration with Global Medical Safety, Product Quality Management (PQM), manufacturing sites, and LOC/BQ for effective complaint handling/MDR assessments and adverse events with potential product quality issues.
Project management and process excellence knowledge to coordinate sophisticated projects, resolve and assign resources and individual tasks.
Able to develop and implement simple, yet effective quality systems and metrics.
Ability to allocate and balance resources across contending priorities; Identify leveraging opportunities and solutions, and mentor others to do the same.
Ability to provide mentorship, collaborate, negotiate, and effectively coach and lead teams and individuals to ensure processes are developed, understood, provide business value, and are adhered to.
Proven organizational change in a global virtual environment for customer engagement and effective change roll out.
Ability to negotiate, influence and lead without direct line authority.
Ability to engage others and lead an organization through continuous improvement and change.
Implementation of effective process improvements supporting quality, compliant, and efficient operations.
Development of procedures, training materials, and other documents vital to support operations.
Qualifications Education.
A minimum of a Bachelor's or equivalent university degree is required with a focus in technical, scientific, or engineering fields required.
Biomedical Engineer, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.
Required.
5 – 8 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related highly regulated industry Knowledge of medical safety environment and regulation Global mentality and proven ability for change initiatives, project management and develop positive relationships Solid understanding of and experience with one of more of the following regulatory requirements.
21 CFR Parts , ISO , ISO , ICH Q10, GDP, GMP, GVP, MEDEV 2.
, CMDR, Medical Device Directive /EEC, and EU .
Other.
This position has an estimated annual salary of USD.
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 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.