Manager, Quality Clinical Risk Management

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

Clinical Quality

Job Category:

Professional

All Job Posting Locations:

Horsham Pennsylvania United States of America Raritan New Jersey United States of America Spring House Pennsylvania United States of America Titusville New Jersey United States of America

Job Description:

Johnson & Johnson is currently seeking a Manager Quality Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in Spring House PA; Titusville NJ; Raritan NJ; Horsham PA: High Wycombe UK: Beerse Belgium; Basel Switzerland and Madrid Spain.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at 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):

US- Requisition Number: R-106260

UK - Requisition Number: R-106893

Belgium - Requisition Number: R-106896

Spain- Requisition Number: R-106903

Switzerland - Requisition Number: R-106912

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

This is a position in R&D Clinical Quality. This Manager role is an independent clinical quality-risk leadership position responsible for translating risk signals into proactive mitigation escalation inspection/submission readiness and quality decision support across trials and programs. The role combines hands-on risk ownership with significant cross-functional influence

With minimal direction from the RDQ Dir Clinical Risk Management:

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 CQP (Clinical 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 RDQ CRM 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 RDQ 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 Portfolio Review (QPR)

Leads the Cross-Functional Trial Team and other key contributors in QPR content

development & follow-up Activities

Coaches and mentors other team members on QPR for coordination and

management of activities

Inspection Readiness and Suppor t

Drives ongoing inspection readiness activities with trial teams to develop inspection

narratives identify and prepare sites of interest for inspection (including preinspection

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) / Integration:

• With the guidance from the CRM 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 activities:

• Participates in CRM cross-RDQ J&J 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

• Required Minimum Education: BA/BSc or equivalent (Scientific medical or related discipline)
• Required Years of Related Experience: A minimum of 8 years of experience working in the healthcare industry (pharmaceutical industry contract research organization and/or healthcare/hospital system) required

Required Knowledge Skills and Abilities:

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

Percentage Traveled:

Up to 10% (Primarily domestic travel with some international travel)

Preferred Related Industry Experience: Healthcare industry (pharmaceutical industry and/or

healthcare/hospital system)

Preferred Knowledge Skills and Abilities:

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

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)

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 internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$102000.00 - $177100.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys long-term incentive program.

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

For additional general information on Company benefits please go to: - Experience:

Manager