Johnson & Johnson Careers
Project Manager, Clinical Quality Assurance
Requisition ID: 1228190404
Johnson& Johnson Vision is recruiting for a Project Manager, Clinical Quality Assurance, located in Jacksonville, FL.
At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.
- Ensures that clinical trials are conducted in compliance with all applicable Good Clinical Practice (GCP) Regulations and Guidelines. Ensures that internal processes and procedures meet the requirements of GCP.
- Conducts audits of investigational sites or Clinical Research Organizations (CRO’s). Develops associated QA Plans.
- Partners with Clinical Operations in the identification, selection and qualification of CRO’s or other external service providers.
- Conducts audits of internal clinic, clinical quality systems, clinical trial documents and reports.
- Interprets GCP, and in general serves as the GCP Subject Matter Expert, for Clinical Project Teams.
- Collaborates with business partners to ensure that Investigational Sites, CRO’s, and internal organizations are ready for regulatory inspections
Masters Complexity - Defines complex issues & develops strategies to address these issues; manages departmental/projects day-to-day operations within area of responsibility, and interrelationship between functions. Spokesperson & technical expert for functional area; makes the complex clear and compelling; conceptual knowledge of all responsible functions and business areas. Represents the department/project in providing solutions to difficult technical issues.
Innovation – Gathers the resources needed to build solutions to technical and tactical clinical issues. Establishes key operating practices for department/project and functional area, ensuring cross-functional alignment. Drives innovation within functional area.
Customer Focus - Develops and implements functional area initiatives to speed the delivery of new products/technologies to the customer.
Interdependent Partnering - Mentors and facilitates successful team behavior within and across functional area. Maintains relationships externally and internally for functional area. Builds cross-functional and cross-departmental support for innovative solutions. Furthers overall group effectiveness.
Organizational & People Development - Holds people accountable for measurable results. Provides useful feedback and direction to teams. Cultivates harmony within functional and other areas. Promotes the business value of different perspectives. Influences and persuades to bring about process and technical improvements
Quality Management System Oversight:
- Provide Quality Assurance Oversight of Clinical and Pre-Clinical R&D Quality Systems
- Work in Close Collaboration with MD BRQC Leadership and Business Partners to Develop and implement Effective GCP and GLP Quality Programs Across Medical Devices.
Audit Planning, Executing and Reporting:
- Internal: Clinical R&D, Pre-Clinical R&D Sponsor Oversight
- External: Clinical Investigational Sites, External Service Providers/Vendors/Contract Research Organizations and Institutional Review Boards.
- Assess, Communicate and Report Audit Findings to MD BRQC Management and Business Partners.
- Review and Monitor Required Corrective Actions; Conduct Follow-up Activities
- Identify and Communicate Noted Compliance Trends to Business Partners
Subject Matter Expertise:
- Serve as internal GCP Expert to R&D Business Partners
- Work in collaboration with business partners to self-identify potential/actual compliance risks
- Collaborate with business partners in developing and implementing mitigation strategies
Inspection Readiness and Management:
- Plan for and support the readiness, management and reporting of third-party inspections
- Audits and other support for pre-/post acquisition
- Special Investigations, including misconduct and fraud
- A minimum of a Bachelors’ Degree is required. A degree in a Scientific or Technical Discipline is preferred
- A minimum of 8 years of experience in Clinical Quality and/or Quality Assurance in the Medical Device Regulated industry is required
- A minimum of 3 years in the R&D/Clinical Trials environment is required
- Complete understanding and application of principles, concepts and practices of clinical research procedures and GCP is required
- Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, etc.) is required
- Ability to effectively negotiate and influence to meet regulatory and business needs is required
- Ability to manage and influence external service providers is required
- This position will be located in Jacksonville, FL and may require up to 25% domestic and/or international travel
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.
Johnson & Johnson Vision Care, Inc. (6094)