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Johnson & Johnson is seeking a Manager, Clinical Quality Lead to provide Clinical quality oversight in support of the Laminar MedTech business. This position is based in Irvine, CA, or an alternative J&J site in the US. Monthly travel will be required for those not local to Irvine, CA.

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 https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.

The Manager, Clinical Quality Lead works to support the R&D Quality objective and strategy in leading all aspects of a robust GxP Quality Management System to enable a diverse portfolio of medical device products and services. This individual serves as the clinical quality point of contact to support Licensing & Acquisition activities, integration, risk assessment, mitigations, remediation, inspections, and provide guidance on compliance-related activities within the business unit in Good Clinical Practice(GCP, ISO 14155:2020), as well as other applicable external regulations/ requirements, and internal JNJ procedures.

The Manager, Clinical Quality Lead is a subject matter authority and acts as a key point of contact for Clinical Research & Development (R&D) functions, as well as other internal collaborators and business partners.

Key Responsibilities

Lead Remediation & Integration

• The Manager, Clinical Quality Lead will plan and lead clinical quality and integration activities to ensure effective execution of new product development, lifecycle management, supplier management, and provide overall clinical quality oversight. Remediation and integration of quality system elements to relevant internal and external standards is also required.

• This position requires expertise in GCP regulations and requirements (e.g., ICH GCP E6, ISO 14155:2020, 21 CFR Part 11, and 21 CFR 812) and experience with remediation and integration activities.

• Partners across multiple functions including Clinical R&D, Quality to define needs for standardization and ensures compliance with standard operating procedures, and applicable regulations and standards. Support new business development initiatives, including due diligences, Post Acquisition Assessments (PAA), etc.

• Coordinates with Regulatory Compliance, Business Development, and the License & Acquisitions teams to integrate newly acquired assets and companies into the base RDQ operating model, as assigned.

• Owns and drives Corrective and Preventative Action Plans, as applicable, related to remediation, integration, and overall clinical quality support.

Portfolio Oversight

• Develops and leads proactive risk management strategies in coordination with Clinical R&D business partners to address and lead the risk mitigation including preventative actions, training, and communications.

• Prepares and provides periodic updates on the state of the applicable QMS to R&D, R&D Quality, Franchise Quality, and Clinical Risk Management.

• Responsible for communicating business related issues or opportunities to management.

• Ensure timely escalation of critical issues in compliance with internal requirements.

• As needed, forecasts headcount and resource needs.

• Support Clinical R&D business partners to ensure compliance with purchasing controls requirements, including risk classification, group categorization, and quality assessments.

• Support development and finalization of supplier quality agreements as required.

• Attend and support Quality System, Clinical R&D management, and any relevant program/ study-level compliance reviews in support of CSS Business.

Compliance Assessments / Audits

• Ensure adequacy of failure investigation plans and supervises action plans / CAPAs to closure.

• May conduct Clinical audits of sponsor oversight, Clinical investigator sites, Clinical vendors, or Clinical processes.

Inspections

• Prepares the team and hosts regulatory inspections with Clinical scope.

• Partners with Regulatory Compliance to develop and align to inspection strategies, including preparation, execution, and resolution activities for Health Authority Inspections

• Acts as SME to support internal audits and inspections where Clinical support is needed (JJRC, ERC, TUV, BSI, FDA, etc.).

• Provide inspection readiness training to internal teams and clinical investigator site personnel as needed.

• Collaborates with external vendors supporting JNJ Studies to ensure appropriate support for third-party/ Health Authority Inspections.

Team Leadership, Cross-Functional Collaborations & Execution

• Collaborate with the Quality Head, Quality Assurance, and other quality functions to develop and implement an effective GCP quality program.

• Lead and/or participate in cross-functional, cross-segment and/or cross-business working groups to deliver key initiatives.

Qualifications

Education:

• University/Bachelors (BA/BS) or equivalent degree required; concentration in Scientific or Business field is beneficial.

Experience & Skills

Required:

• Six to eight (6-8) years of Clinical research or Clinical quality related experience

• Experience in a medium- to large scale, life sciences organization.

• Medical device/MedTech industry or equivalent healthcare industry experience

• Strong working knowledge of GCP, ISO 14155:2020, ICH-GCP, 21 CFR Part 11, 21 CFR 812, 814, 822, 820 and other relevant standards and regulations for clinical research.

• Ability to motivate colleagues and collaborators at all levels of the organization.

• Demonstrated experience establishing collaborative relationships and leading cross functional teams to deliver results.

• Innovative approach to build and maintain a competitive advantage.

• Conflict resolution, management, and negotiation skills.

• Ability to articulate complex concepts or issues to non-expert business partners or Leadership Teams.

• Outstanding written and verbal communications skills in English.

• Strong project management and execution skills.

• Ability to interpret data to develop action plans as part of risk mitigation and / or continuous improvements as part of risk mitigation and / or continuous improvements.

• Ability to prioritize tasks, lead several projects simultaneously, and operative effectively in a multi-disciplinary environment.

• Significant work experience to show a track record of working across functions and business units in a manner that is aligned with J&J Credo.

Preferred:

• Licensing, mergers/acquisitions experience.

• Experience in a customer/external facing role is strongly preferred.

• Health authority inspection experience is desirable.

Other:

• The candidate is expected to travel up to 25%, primarily domestic.

• Eligible to participate in the J&J Flex hybrid working model, working onsite at least three days per week.

• The anticipated base pay range for this position is $100,000 to $172,500.

• The anticipated base pay range for this position, in the Bay Area, is $114,000 to $197,800.

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.