Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Project Manager, Clinical QA to be located in Jacksonville, Florida.
VISTAKON®, a division of Johnson & Johnson Vision Care, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe / Middle East / Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, no other manufacturer has matched the aggressive expansion of our wide-ranging ACUVUE® family of products. Our associates around the world are committed to expanding the ACUVUE® brand, and fortifying our position as the worldwide leader in the contact lens industry.
- Ensures that clinical trials are conducted in compliance with all applicable GCP Regulations and Guidelines. Ensures that internal processes and procedures meet the requirements of GCP.
- Conducts, or directly manages the conduct of, 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.
- Conducts, or directly manages the conduct of, 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 Clinical Operations 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 create solutions to technical and tactical clinical issues. Establishes key operating practices for department/project and functional area, ensuring cross-functional synergy. 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. Manages relationships externally and internally for functional area. Builds cross-functional and cross-departmental support for innovative solutions. Fosters overall group effectiveness.
Organizational & People Development - Holds people accountable for measurable results. Provides coaching, useful feedback, and direction to teams. Fosters harmony within functional and other areas. Promotes the business value of diverse perspectives. Influences and persuades to bring about process and technical improvements
- Develops Quality Plans for studies and CRO’s. Ensures execution of the Quality Plans. Manages contract resources in the execution of the Quality Plans.
- Partners with Clinical Operations in the qualification of CRO’s.
- Performs audits of the internal clinic, clinical trial documents, test article reconciliation, etc.
- Supports the organization in preparation and management of third party inspections.
- Provides GCP guidance to Clinical Operations, Project Teams, and external service providers, as appropriate.
• A minimum of a Bachelors’ Degree is required¸ preferably in a Scientific or Technical Discipline.
• A minimum of 7- 8 years of experience in 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 Good Clinical Practice (GCP) is required.
• Strategic & tactical Clinical and Business knowledge to guide the organization in regulatory inspections is required. Strong communication, organizational and interpersonal skills.
• Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, etc.) is an asset. Ability to effectively negotiate and influence upper management, affiliates and Regulatory Agencies to ensure that regulatory and business needs are met. Ability to manage and influence external service providers.
• This position has 20-30% domestic travel with possibility for international travel and will be based in Jacksonville, Florida.
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Johnson & Johnson Vision Care, Inc. (6094)Job Function
Quality (Generalist)Requisition ID