Manager 1, Quality

Manager 1, Quality - 2306111332WDescriptionJanssen Research & Development, LLC., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Manager . This position will be based in Spring House, Pennsylvania. Considerations may be given for remote work options.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.The MANAGER (TA Risk Management) works with the trial teams and/or Program teams to coordinate the identification, assessment, and mitigation of quality risks that could impact on trial data integrity, patient safety, well – being, or rights.Throughout the duration of the trial/program, this MANAGER executes data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.Duties & ResponsibilitiesRisk Management with minimal direction from the Associate Director/Director, Therapeutic Area (TA) Risk Management:

Actively participates all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies.

Leads regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned).

Maintains IQP (Integrated Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews

Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews

Communicates and facilitates risk updates to R&D Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).

Highlight new potential systemic risk to BRQC QP&S management.

Issue Consultation, Issue Escalation, and Compliance Assessment:

Develops and ensures a consistent interpretation of issues that require quality investigations

Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management.

Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities

In collaboration with partners in BRQC, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit)

Submission Support: Pre-submission Quality Stage Gate Review (SGR)

Leads the Cross-Functional Trial Team and other key contributors in SGR content development & follow-up Activities

Coaches and mentors other team members on SGR for coordination and management of activities

Inspection Readiness and Support

Drives ongoing inspection readiness activities with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.

Provides front and back room support for Sponsor-Monitor inspections at J&J Sites, including post inspection support. Provide inspection support per contractual agreement for third party inspections (vendors, co-development partners, and contract research organizations.

Provides remote support for investigational site inspections including post inspection support.

Provides supervision and/or coaching for others on inspection support and readiness.

Consultancy

Provides independent advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.

Post-licensing and Acquisition (L&A) / IntegrationWith the guidance from the QP&S L&A Team and Therapeutic Area Head or Delegate:

Support the coordination of the quality integration of the acquiring asset or company/partner and deliver robust documentation within the program/trial integration plans (90-day plan) and execute assigned responsibilities per plan.

Provide general guidance to stakeholders

As required, provide input into Quality Agreements with (Co-)development Partners and execute responsibilities per agreement.

Supports and facilitates asset divestment

Other Duties

Participates in QP&S, cross-BRQC Janssen, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions (as a team member or workstream/project lead).

Works with limited supervision, independently making decisions for compounds and studies

Provides training and coaching to peers and new employees, as needed

QualificationsRequired:

BA/BS or equivalent (Scientific, medical, or related discipline)

A minimum of 8 years of experience working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) required

Proficiency in Microsoft Office Applications

Proficiency in speaking and writing English

Excellent interpersonal, oral, and written communication skills

Proven strong GCP quality and/or clinical trials experience

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

Travel up to 10%, primarily domestic travel with some international travel

Preferred:

Advanced degree preferred in Scientific, medical, or related discipline

Healthcare industry (pharmaceutical industry and/or healthcare/hospital system) experience

Knowledge of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)

Specific Therapeutic Area experience may be required depending on the position.

Experience with fundamentals of clinical trial risk management

Global clinical trial experience

Experience working in a Quality function (Quality Management, Quality Assurance/Control and/or Compliance)

Experience working to ICH guidelines

Health Authority Inspection experience (FDA, EMA, and other inspectorates)

Strong Project Planning/Management skills

Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related)

Proven ability to analyze & interpret collective data to provide insights to drive decision-making

Experience in managing escalations and CAPA support/advisement

Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)

Other:

The anticipated base pay range for this position is $112,000 to $168,500.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits .

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work.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.careers.jnj.com.Primary Location NA-US-Pennsylvania-Spring HouseOther Locations NA-United States, Asia PacificOrganization Janssen Research & Development, LLC (6084)Job Function Quality (Generalist)Req ID: 2306111332W