Sr Specialist, Clinical Risk Management

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 jnj.com

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:

Irvine, California, United States of America, Jacksonville, Florida, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Specialist, Clinical Quality Risk Management! This position can be located in Irvine, California or Jacksonville, FL

Position Summary:

The Sr. Specialist, Clinical Quality Risk Management works to support the Clinical Quality Risk Management (CQRM) objectives, overseeing 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 clinical trial risk assessments, Integrated Quality Plans (IQP), risk mitigations, inspections, and provide guidance to ensure compliance with Good Clinical Practices (GCP), external regulations/requirements, and internal J&J Vision procedures. The Manager is a subject matter expert and acts as a contact for Clinical Research & Development (R&D) functions to internal stakeholders and business partners.

Key Responsibilities:

The scope of responsibilities for the position will be applicable to the J&J Vision business, which includes J&J Vision Care and J&J Surgical Vision.
Clinical Portfolio Oversight

• Function as a subject matter authority for GCP for J&J Vision and be responsible for supporting, or leading as assigned, quality initiatives.
• Serve as a clinical quality point of contact for inspections, IQP and clinical study / program compliance concerns / escalation.
• Provide clinical quality oversight to clinical business partners to ensure compliance • with applicable GCP regulatory requirements, J&J Standards, and applicable J&J Vision SOPs.

Risk Management & Governance

• Establish routine presentation of compliance trends and metrics to business partners and help champion organizational performance and improvements measures.
• Develop and manage proactive risk management strategies in coordination with R&D leaders.
• Serve as a subject matter expert for Good Clinical Practice (GCP). Collaborate with Clinical R&D to ensure that investigational sites and external service providers supporting JNJ studies have appropriate support for the management of third-party inspections.

Quality Systems & Collaborations

• Oversee the Quality Management Systems (QMS) so that it fits in seamlessly with the MedTech strategies and policies and evolving industry and regulatory demands.
• Assist the Franchise Head with interdepartmental and cross-functional strategic planning and budget management.

Team Leadership, Cross-Functional Collaborations & Execution

• Report to and work in close collaboration with the Franchise Director(s) and Quality Assurance and other quality functions to develop and implement effective GCP quality programs across the Franchises.

Qualifications:

Education:

A minimum of a Bachelors or equivalent University degree is required with a focus degree in scientific discipline or business preferred.

Skills & Capabilities:

• Five to seven (5-7) 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, ISO14155:2020, ICH-GCP, 21CFR Part 11, 21 CFR
• 812 and other relevant standards and regulations for clinical research.