CAPA Manager - Home Based (East Coast)

As a CAPA Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing: 

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 (pe. GTLs, …) across therapeutic areas as the subject matter expert on CAPA development and follow up as it pertains to our business processes and SOPs.

Deliverables:

• Services rendered will adhere to client 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 (IO) 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 client 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 IO (Investigation Owner)

What you need to have: 

• A minimum of a bachelor’s degree in science (BSc) or Arts (BA) or 6-8 years relevant experience equivalent is required.
• A minimum of 6 years of previous 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
• To qualify, applicants must be legally authorized to work in the US and/or Canada, and should not require, now or in the future, sponsorship for employment visa status

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.