CFSP Quality Specialist; CAPA Management

Overview:

The services include primarily supporting the function and the function personnel in all aspects of Corrective Action Preventative Action (CAPA) development as a direct result of internal and/or external audits, health authority inspections and self-identified issues that lead to a CAPA owned by the function personnel for both in-house and outsourced trials, and in working with all types of strategic partners and vendors. The person performing these services will support the function personnel across therapeutic areas as the subject matter expert on CAPA development and follow up as it pertains to J&J business processes and SOPs.

Deliverables:

• Services rendered will adhere to applicable Johnson & Johnson SOPs, Wis, policies, local regulatory requirements, ICH-GCP, etc.
• Main responsibilities will include, but are not limited to:
• Act as process and system SME for the nonconformance and CAPA process and business/system requirements
• Assist the Investigation Owner (10) in the application of structured problem-solving methodologies in Root Cause Analysis (RCA) investigations (Fishbone, 5 Whys, etc) independently or in support of the Root Cause Investigation team
• Coach the Investigation Owner in understanding their end-to-end accountability of the entire
  CAPA process
• Develop and maintain proficiency in the TrackWise ETS QEM system
• Work with the organization to identify resources to support RCA investigations and resulting
  actions
• Provide assistance to the record owner to ensure process requirements are met
• Monitor nonconformance and CAPA deliverables / timelines for functional area by running reports, communicating upcoming deadlines to record owners and escalating concerns to management as appropriate to actively drive compliance
• Act as a liaison between the record owner and the quality leader; the record owner and the Root Cause Analysis group; the record owner and the TrackWise central entry team.
• Escalate any issues, as needed, to the BRQC Janssen CAPA Review Board
  Raise any process or system questions or concerns to the CAPA Champions Community of Practice
• Manage requests for assistance from the TrackWise central data entry team on behalf of the 10

Education and Experience:

• Bachelor’s Degree or experience in lieu of a degree.
• Pharmaceutical Industry experience is required, with at least 3-4 years of GXP experience within clinical research and development and/or quality assurance.
• Experience in Quality Control and Compliance, Quality Assurance, CAPA process and/or Root Cause Analysis.
• Knowledge of the overall drug development process
• Well-developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
• Ability to translate data into information and strategies into executable action plans improving the business
• Ability to motivate professional colleagues and stakeholders
• Conflict resolution/management and negotiation skills
  Ability to independently plan, organize, coordinate, manage and execute assigned tasks
• Experience of the key customers' business processes and practices