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 entireCAPA process

Develop and maintain proficiency in the TrackWise ETS QEM system

Work with the organization to identify resources to support RCA investigations and resultingactions

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 BoardRaise 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 skillsAbility to independently plan, organize, coordinate, manage and execute assigned tasks

Experience of the key customers business processes and practices

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $75,500.00 – $125,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled