Manager, Clinical Quality Cardiovascular Specialties & Solutions (CSS) Lead - 2406199887W

Description

Johnson & Johnson is seeking a Manager, Clinical Quality Cardiovascular Specialties & Solutions (CSS) Lead to provide bioresearch quality oversight in support of the Cardiovascular Specialty Solutions (CSS) MedTech business. This position is based in Irvine, CA or Santa Rosa, CA. This position is eligible to participate in the J&J Flex hybrid working model, working both onsite and remotely.

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- CSS 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 GLP & GCP, ISO 14155:2020, as well as other applicable external regulations/ requirements, and internal JNJ procedures.

The Manager, Clinical Quality Lead-CSS is a subject matter authority and acts as a key point of contact for Pre-Clinical and 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 - CSS will plan and lead quality and integration activities to ensure effective execution of new product development, lifecycle management, supplier management, and provide overall preclinical and clinical quality oversight. Remediation and Integration of quality system elements to relevant internal and external standards is also required.

• This position requires expertise in GLP, GCP regulations and requirements (e.g., 21 CFR Part 58, ISO 14155:2020, 21 CFR Part 11, and 21 CFR 812) and experience with remediation and integration activities.

• Partners with Preclinical & Clinical R&D and across functions 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.

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

• Own CAPA/ DRA as applicable related to remediation / integration activities.

Portfolio Oversight

• Prepare and provide periodic updates on the state of the applicable QMS to R&D, R&D Quality, Franchise Quality, and CRM Management

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

• Develop and lead proactive risk management strategies in coordination with Preclinical and Clinical R&D business partners.

• Proactively assess clinical and preclinical risks to the business and work with management to devise and implement policies and procedures to address and lead the risk including preventative actions, training, and communications.

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

• Maintains dashboards and other reports of performance & project status as required.

• As needed, forecasts headcount and resource needs.

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

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

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

Compliance Assessments / Audits

• May conduct Preclinical and/ or Clinical audits of sponsor oversight, biocompatibility/ toxicology, clinical investigator sites, Preclinical & Clinical vendors, or Preclinical & Clinical processes.

• Consult with business partners and quality peers to provide guidance on Quality Issues, nonconformances (NC) and Corrective and Preventative Action Plans (CAPA). Develop NCs and/or CAPAs, as the need arises.

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

• Consult with business partners and RDQ peers to provide guidance on Quality Issues, nonconformances (NC) and Corrective and Preventative Action Plans (CAPA). Develop NCs and/or CAPAs, as required.

Inspections

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

• Prepares the team and hosts regulatory inspections with Preclinical / Clinical Scope.

• Acts as SME to support internal audits and inspections where Preclinical / Clinical support is needed (JJRC, ERC, 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 leading 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 GLP / 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 in Scientific field is required.

• Advanced degree or equivalent experience in Science or Business is preferred.

Experience & Skills

Required:

• Five to seven (5-7) years of related experience.

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

• Experience in a related area or GxP regulated field.

• Medical device/MedTech industry or equivalent healthcare industry experience

• Strong working knowledge of 21 CFR Part 58, ISO14155:2020, ICH-GCP, 21CFR Part 11, 21 CFR 812 and other relevant standards and regulations for preclinical and clinical research.

• Health authority inspection experience is desirable.

• Demonstrated experience engaging and establishing collaborator relationships.

• Innovative approach to build and maintain a competitive advantage.

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

• 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.

• Demonstrate leadership skills and experience leading cross functional teams to deliver results.

• 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, consulting experience is preferred.

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

Other:

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

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-California-Santa Rosa

Other Locations NA-US-California-Irvine

Organization Biosense Webster Inc. (6010)

Relocation Eligible: No

Travel Yes, 25 % of the Time

Job Function Quality Assurance

Req ID: 2406199887W