Manager, Johnson & Johnson Enterprise Innovation (JJEI) Quality Risk Management - 2406160237W

　　Description

　　Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for a Manager, Johnson & Johnson Enterprise Innovation (JJEI) Quality Risk Management. This position will be based remotely within the United States , with the candidate located in New Jersey or Pennsylvania, preferably.

　　A pre-identified candidate for consideration has been identified. However, all applications will be considered.

　　At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com (file:///C:/Users/jamie yacco/AppData/Local/Microsoft/Windows/Temporary Internet Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

　　Key Responsibilities:

　　The Manager, JJEI Quality Risk Management (QRM) is responsible for ensuring continuous improvement and sustainability of the Research & Development Quality (RDQ) Compliance Program in accordance with applicable regulatory requirements, current Good Clinical Practices, Good Laboratory Practices and Good Pharmacovigilance Practices, Safety Vigilance and company policies and procedures. The Manager is responsible for assessing compliance risks and analyzing information in order to provide management with risk assessments based on current regulations and company standards. The Manager will ensure appropriate actions are taken regarding various issues, systemic or otherwise.

　　Actively participates in R&D and Post-Marketing study activities, contributing to the identification and assessment of key risks and advising team members on effective mitigation strategies.

　　Highlight new, potential, systemic risks to management.

　　Collaborates with business partners across departments, franchises, sectors and RDQ to advise, collaborate and solve on areas for improvement.

　　Facilitates the JJEI Quality Planning process to identify and monitor quality objectives and progress.

　　Provide the processes, tools, and support to enable JJEI to identify and communicate product quality complaints, adverse events, and other issues.

　　Facilitate the Escalation process for JJEI quality and regulatory issues and events.

　　Assist in the development of a Quality Audit Program to monitor the effectiveness of the quality system, monitor the quality system of applicable suppliers, and run external audits (including Health Authority / Regulatory Agency Inspections).

　　Collaborate with appropriate RDQ teams and/or sector business partners to:

　　Provide Documentation Management processes, tools, and support to enable JJEI management of procedural documents

　　Provide Purchasing Controls processes, tools, and support to enable the JJEI use of Qualified Suppliers

　　Facilitate the quality and compliance due diligence assessment of external opportunities

　　Assess and recommend the processes, tools, and support to enable the management of JJEI Nonconformance, Root Cause & Corrective Action and/or Preventative Action (CAPA).

　　Serve as the RDQ representative on JJEI solution development / clinical study teams.

　　Participate in the ongoing development, deployment and execution of an agile clinical trial oversight model for the JJEI organization to enable the development of an innovative portfolio for single and cross sector programs.

　　Support new asset and company integration as needed. Coordinate with the sector and JJEI to identify RDQ GxP quality risks in the post-acquisition phases and present integrated risk management solutions to senior leadership teams.

　　Function as an advisor concerning GCP, GLP, GVP, and Good Documentation Practices (GDP), providing appropriate compliance guidance to personnel performing human use activities. Contributes to implementation of processes and systems that lead to collection of data relevant to reporting quality metrics and continuous improvement.

　　Oversee quality system element responsible team(s) to ensure appropriate management and support of JJEI core QMS related activities (e.g., Audit Management, Inspection Management, Escalation, Qualification & Training, Document Controls, Purchasing Controls, NC/CAPA).In collaboration with partners in RDQ QA, advises on the GCP audit schedule (Consumer, JJEI), reviews audit results to detect trends and facilitates mitigation of such trends.

　　Participate in QRM, cross-RDQ, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions.

　　Trains or coach peers, business partners and new employees.

　　Exhibits excellent interpersonal, oral, and written communication skills.

　　Flexibility to respond to changing business needs.

　　Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures.

　　Qualifications

　　Education:

　　University/Bachelors or equivalent degree requiredExperience and Skills

　　Required:

　　A minimum of ten (10) years of experience working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) requiredPreferred:

　　Proficiency in Microsoft Office Applications

　　Proficiency in speaking and writing English

　　Excellent interpersonal, oral and written communication skills

　　GCP quality and/or clinical trials experience in pharmaceutical or other regulated product development

　　Experience collaborating in a cross-functional team environment

　　Flexibility to respond to changing business needs

　　Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures

　　Other:

　　Advanced degree in Scientific, Medical or related discipline preferred

　　Experience in Healthcare industry (Pharmaceutical industry and/or healthcare/hospital system)

　　The anticipated base pay range for this position is $99,000 to $170,200

　　The anticipated base pay range for this position, in the Bay Area, is $113,000 to $195,730

　　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.careers.jnj.com/employee-benefits

　　For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

　　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.

　　Primary Location NA-US-New Jersey-New Brunswick

　　Organization Janssen Research & Development, LLC (6084)

　　Relocation Eligible: No

　　Travel Yes, 10 % of the Time

　　Job Function Quality Assurance

　　Req ID: 2406160237W