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Manager, Clinical
3 months ago
Johnson & Johnson, Cardiovascular & Specialty Solutions (CSS) is recruiting for a **Manager, Clinical / Preclinical Quality Cardiovascular Specialties & Solutions (CSS). This is a remote position but travel to the site in either Santa Rosa, CA **or **Irvine, CA is required.**
Johnson & Johnson is seeking an experienced professional to lead clinical / preclinical quality oversight in support of the CSS MedTech business. The Manager, Clinical / Preclinical Quality Cardiovascular Specialties & Solutions (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 person will serve as the clinical / preclinical 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.
**Key Responsibilities**:
**Lead Remediation & Integration**
- The Manager, Clinical / Preclinical Quality Cardiovascular Specialties & Solutions (CSS) will plan and lead quality integration activities to ensure effective execution of new product development, lifecycle management, supplier management, while providing overall preclinical and clinical quality oversight. This leader is responsible for remediation and integration of quality system elements to relevant internal and external standards as required.
- The leader requires expertise in GLP, GCP regulations requirements (e.g., 21 CFR Part 58, ISO 14155:2020, 21 CFR Part 11, and 21 CFR 812).
- Partners with Clinical and Preclinical R&D and across other functions to define needs for standardization and to ensure compliance with standard operating procedures, applicable regulations, and standards. The leader supports new business development initiatives, including due diligences, post acquisition assessments/ audits as the need arises.
- Coordinates with Regulatory Compliance, Business Development, and the License & Acquisitions team to integrate newly acquired assets and companies into the base RDQ operating model.
- Owns CAPA/ Data Review Activities 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 Clinical Risk Management, including. Responsible for communicating business related issues or opportunities to management.
- Develop and lead proactive risk management strategies in coordination with Clinical and Preclinical 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 risk mitigation strategies including preventative actions, training, and communications.
- Ensure timely escalation of critical issues in compliance with internal requirements.
- As needed, forecasts headcount and resource needs.
- Support clinical and preclinical 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 the needed.
- 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**:
- As needed, 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 RDQ peers to provide guidance on Quality Issues, nonconformances (NC) and Corrective and Preventative Action Plans (CAPA). Develop NCs and/or CAPAs, as required. Ensure adequacy of failure investigation plans and track action plans / CAPAs to closure.
**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 clinical and / or preclinical scope. Acts as SME to support internal audits and inspections where clinical and / or preclinical support is needed (JJRC, ERC, etc.). Provide inspection readiness training to internal teams and clinical investigator site personnel as needed.
**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 in
