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.

About the Role

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 role acts as a subject matter expert and contact for Clinical Research & Development (R&D) functions to internal stakeholders and business partners.

This position can be located in Irvine, California or Jacksonville, Florida.

Responsibilities

• 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.
• 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 investigational sites and external service providers supporting JNJ studies have appropriate support for the management of third-party inspections.
• Oversee the Quality Management Systems (QMS) so that it fits 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.
• 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.

Requirements

• A minimum of a Bachelor’s or equivalent University degree is required, with a focus degree in a scientific discipline or business preferred.
• 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, 21 CFR Part 11, 21 CFR 812, and other relevant standards and regulations for clinical research.
• Health authority inspection experience is desirable.
• 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.
• Requires a minimum of 5 years of work experience within clinical research or clinical quality-related function.
• Experience working in the Medical Device industry is required.
• A thorough understanding and experience with the application of Good Clinical Practice (GCP) and Quality System Regulation is required.
• Regulatory/Health Authority inspection experience.
• Experience engaging with and establishing stakeholder relationships.
• Decision-making, prioritization, and ability to lead cross-functional teams.
• Interpersonal skills and demonstrated ability to effectively negotiate and influence.
• Experience and proficiency with basic office software tools (e.g., Microsoft Word, PowerPoint, Excel, Outlook) and internet browsers (e.g., Internet Explorer, Chrome).
• Excellent verbal and written communication skills, including presentation skills.
• Project management savvy, problem-solving, business/financial acumen, and process excellence understanding of methodologies.

Benefits

• Retirement plan (pension) and savings plan (401(k)).
• Vacation – 120 hours per calendar year.
• Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents).
• Holiday pay, including Floating Holidays – 13 days per calendar year.
• Work, Personal, and Family Time – up to 40 hours per calendar year.
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.
• Bereavement Leave – 240 hours for an immediate family member, 40 hours for an extended family member per calendar year.
• Caregiver Leave – 80 hours in a 52-week rolling period.
• Volunteer Leave – 32 hours per calendar year.
• Military Spouse Time-Off – 80 hours per calendar year.

Pay

The anticipated base pay range for this position is $94,000.00 - $151,800.00.