Product Quality Vigilance, E2E Supervisor

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

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Product Quality Vigilance (PQV) E2E Supervisor! This position can be located in Horsham, PA, Titusville, NJ, Beerse Belgium, Cork Ireland or Latina, Italy.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
North America- Requisition #R-073909
EMEA– Requisition# R-076329

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Position Summary:

The Product Quality Vigilance (PQV) (Combo or Non-Combo) Supervisor is responsible for the execution and oversight of activities in conformance to current standards and procedures, using applicable system application tools (e.g., PQMS, Tableau). The Supervisor will oversee a staff of analysts who execute the product quality vigilance process, ensuring timelines are adhered to, manage priorities and escalate risk when necessary to management.  This role participates, directly or indirectly, in regional and global product quality vigilance initiatives, and project teams, to develop, consolidate and/or improve Product Quality Vigilance and related/interfacing processes, and supports (PQV) management with internal auditors and external Regulatory Inspections.

 The Supervisor oversees coordination and prioritization of the activities of the team members responsible for PQV process execution including the management of product quality intake, triage, investigations, issue escalation/management, improvement programs, trending and reporting. The role is responsible for the evaluation of data and preparation of reports for management and business partners. Collaboration on local, regional and global levels with Call Centers, LOC’s, Medical Safety, Quality (External and Internal sites) and other business partners as required.  The Supervisor ensures compliance with corporate policies and procedures, internal requirements and regulatory agency requirements as they relate to Product Quality Vigilance.

 This role reports to the Manager, Sr. Manager, Associate Director or Director PQV.

Key Responsibilities:

• Perform end-to-end complaint handling activities, including but not limited to intake, triaging, recovery of field samples for evaluation follow up and outreach with complainant / LOC / Call center trend analysis, defect coding, risk criticality assessment, ensuring accurate/holistic investigation, and review and closure.  
• Demonstrated knowledge and expertise with other quality systems such as; quality Investigations, change control, quality policy standards.  Ability to evaluate quality system elements and recommend improvements to meet regulatory requirements.
• Manage initiatives and lead efforts to oversee complex projects, determine and assign resources and individual tasks.  Ability to develop and implement simple, yet effective quality systems and metrics.
• Demonstrated understanding of basic manufacturing processes, product knowledge and associated GMP compliance requirements. Able to apply this knowledge in combination with quality system requirements to lead and develop quality system processes and applications for global patient and healthcare provider needs.
• Support management to allocate and balance resources across competing priorities. Identify leveraging opportunities and solutions, and mentor others to do the same. Ability to provide guidance, collaborate, negotiate, and effectively coach and direct teams and individuals to ensure processes are developed, understood, provide business value, and are adhered to.
• Lead and coach team supporting product quality complaint handling/vigilance, ensuring each member has clearly established goals and objectives, monitors staff performance and having development plans aligned to divisional/Corporate requirements.  
• Demonstrated change management in a global virtual environment for stakeholder engagement and effective change roll out.
• Ability to engage and align with other diverse and dispersed organizations and functions. Ability to negotiate, influence and lead without direct line authority. Ability to engage others and lead an organization through continuous improvement and change.
• Identify and Implementation of effective process improvements supporting quality, compliant, and efficient operations.
• Development of procedures, training materials, and other documents necessary to support operations.
• Assessment of severity and impact of a product quality complaint through analysis and interpretation of data, documents, and trends.  Data may be gathered from a variety of sources including but not limited to: batch records, certificate of analysis, specifications, lab analyses, packaging, packaging labels, trending reports, investigation reports, complaint threshold reports, and the returned product.
• Determination and implementation of effective CAPAs in addressing complaints.
• Advanced computer skills specifically in Microsoft Word, Excel and PowerPoint.
• Strong technical writing, verbal communication and interpersonal skills.
• Strong problem-solving skills.

Qualifications:

Education

Bachelor’s degree required; degree in Science, Engineering, Pharmacy, or related discipline preferred.

Biomedical Engineer, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.

Skills & Experience:

• 6-8 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceuticals, biologics and/or Medical Device or other related highly regulated industry.
• Knowledge of medical safety environment and regulations for pharmaceuticals, devices and/or biologics.   
• Global mindset and demonstrated ability for change initiatives, project management and develop strong relationships.
• Working knowledge of, and experience with, the more than one of the following regulatory requirements: 21 CFR parts 4, 820, 803, 806, 210, 211, 314, ISO1 3485:2003, ISO 14971:2007/2012, ICH Q10, GDP, GMP, GVP, MEDEV 2.12, CMDR and the Medical Device Directive 93/42/EEC  

Other:

This position may require up to 10% domestic & international travel.

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:

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year