Clinical Supplier Quality Manager

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

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Johnson & Johnson MedTech Research & Development Quality (RDQ) is recruiting for Clinical Supplier Quality Manager. The preferred locations are: Raritan NJ Titusville NJ Bridgewater NJ West Chester PA Bridgewater MA Spring House PA; Warsaw IN Raynham MA; Jacksonville FL or Irvine CA. However the role can be performed at any location in the US.

Remote work options may be considered on a case-by-case basis and if approved by the company.

About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at Manager Clinical Supplier Quality is responsible for ensuring robust procedures and processes are in place to support quality risk management activities of clinical suppliers across MT business units integrated into J&J MedTech QMS. The Manager works to support the objectives of the functional group enabling robust GxP Quality Management System of a diverse portfolio of drug and medical device health products and services. This individual serves as the clinical supplier quality point of contact to ensure quality of the GxP system compliance with regulatory requirements and SOPs and to ensure a continued state of inspection readiness. May lead targeted activities as directed by management including risk assessments mitigations conduct qualification audits and provide guidance to ensure compliance with Good Clinical Practices (GCP) external regulations/ requirements and internal JNJ procedures. The role also serves as a subject matter expert and liaison for Clinical Business Units and R&D functions ensuring quality and regulatory compliance within the organization.

Key Responsibilities:

• Collaborate with quality leads to establish and oversee clinical supplier quality procedures aligned with J&J MedTech QMS.
• Monitor the clinical supplier portfolio to ensure effective risk management and compliance.
• Support inspection readiness and serve as the primary contact for audits and compliance issues.
• Ensures that clinical suppliers are managed in compliance with all applicable GCP Regulations and Guidelines. Ensures that internal processes and procedures meet the requirements of GCP.
• Assist the Clinical QA Team Lead with interdepartmental and cross-functional strategic planning and inputs for budget management.
• Collaborate with cross-functional leadership (e.g. Procurement Clinical Operations Franchise Quality R&D etc.) to identify risk mitigation activities to manage systemic risks identified through execution of clinical supplier quality lead activities as assigned
• Tracks clinical supplier portfolio data to ensure effective clinical risk management coverage of portfolio
• Develop and implement SOPs for supplier management aligning with regulatory and organizational standards.
• Drive inputs for the Quality Management Systems (QMS) so that it fits in seamlessly with the MedTech segments strategies and policies and evolving industry and regulatory demands.
• Partners with Clinical in the identification selection monitoring and qualification of clinical suppliers as applicable.
• Provide inputs for the J&J Approved Supplier List (ASL) including addition of newly qualified Bioresearch suppliers maintenance of active suppliers and disengagement of inactive suppliers
• Facilitate periodic functional review of Approved Supplier List to confirm all GxP impacting suppliers are included
• Lead and mentor cross-functional teams fostering collaboration and supporting program development.
• Support initiatives for automation data management and integration post-acquisition or licensing improving overall quality processes.
• Contribute to establishing routine presentation of compliance trends and metrics to business partners and help champion organizational performance and improvements measures.
• Lead/support supplier qualification activities and supplier audits as assigned
• May support the development and implement Corrective and Preventative Action Plans (Self-Identified Inspection).
• Play a key role in implementing supporting and reporting out (compliance trends metrics)
• Manage relationships externally and internally for functional area. Builds cross-functional and cross-departmental support for innovative solutions. Fosters overall group effectiveness

Qualifications

Education:

• Bachelor of Science (BS/BSc) Bachelor of Arts (BA) or equivalent degree is required.

Experience and Skills:

Required:

• A minimum of 6 years of experience in a medium- to large-scale matrix organization that includes applicable compliance-related field and/or equivalent time and experience in a related medical device R&D area
• Good understanding and application of principles concepts and practices of clinical research procedures and Good Clinical Practice (GCP)
• Strong solid understanding of the overall medical device combination products or pharmaceutical product development process and health authority/country-specific regulations and guidelines related to clinical development and experience with regulatory submissions (NDA IDE 510k PMA BLA etc.)
• Must have strong personal leadership skills with proven competency collaborating with all levels of the organization including senior leadership
• Experience in R&D process requirements to successfully drive Q&C productivity strategy optimization process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analyses.
• Computer literacy & Analytics - Experience using standard applications/systems & data analytics tools is required. Strong proficiency in English
• Ability to interpret data into strategic and executable plans
• Strong communication data analysis organizational and interpersonal skills
• Ability to independently plan organize coordinate manage and execute assigned tasks with little supervision
• Ability to manage and influence External Service providers

Preferred:

• Ability to effectively negotiate and influence upper management affiliates and Regulatory Agencies to ensure that regulatory and business needs are met
• Inspection leading/hosting experience (FDA EMA and other inspectorates)
• Broad based technical knowledge and skills in diverse areas of business (e.g. R&D Operations QA laboratories etc.)
• Knowledge of the device development process sound research and development practices scientific and quality terminology company quality assurance procedures and policies and quality evaluation techniques.
• Strong auditing experience preferably in IT or Supplier quality

Other:

• Travel up to 30% domestic and/or international is required
• Exceptional written and verbal communications skills is required
• Excellent communicator and presenter with exceptional interpersonal skills and diplomacy
• Knowledge of the corporate structure and culture is preferred
• Proactive strategic thinker and problem solver
• Highly committed to quality

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 and 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 please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :