CAPA Manager

Johnson & Johnson • New Brunswick, PA

6d • Remote

About The Position

The CAPA Manager will support Delivery Units, and its Investigation Owners (IO) in the Corrective Action Preventive Action (CAPA) development and implementation process as a direct result of audits, inspections, and self-identified issues for both in-house and outsourced trials with a regional/global scope. He/she will oversee the Nonconformance/CAPA process and serve as the CAPA process expert for investigation owners through nonconformance identification, investigation, execution, and resolution.

Requirements

• A minimum of a Bachelor s Degree in Science (BSc) or Arts (BA) and a minimum of 7-8 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.
• 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.
• Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development.
• Strong personal leadership skills with demonstrated competency interfacing with all levels of the organization including senior leaders; Strong networking and relationship building skills; Ability to create an open and inviting environment; Embraces generational differences.
• Demonstrated project leadership skills.
• Problem solver
• Excellent organization skills
• Excellent written and verbal communication skills
• Excellent independent time management skills
• Proven ability to plan and track deliverables and timelines
• Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business
• Problem solver
• Strategic thinker
• Leader and collaborator
• Highly committed to quality
• Flexible and persistent
• Good conflict handling/negotiation skills
• Able to create win-win situations with internal and external partners.
• Knowledge of the corporate structure and culture
• Requires limited supervision and functions with autonomy.
• May directly or indirectly lead or supervise other employees for small projects/teams.
• Possess excellent written, oral communication, interpersonal skills, diplomacy, and presentation skills and outstanding customer service.
• Excellent knowledge of English is required.
• Proficient in Microsoft Office applications

Nice To Haves

• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset.

Responsibilities

• Act as CAPA Champion when regional/global roles in DUs are assigned as Investigator Owners of a nonconformance.
• Act as process and system SME for the nonconformance and CAPA process and business/system requirements.
• Assist the Investigation Owner 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 COMET.
• Work with the organization to identify resources to support RCA investigations and resulting actions.
• Provide assistance to the Investigation 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 IO and the quality leader; the IO and the Root Cause Analysis group; the IO and the Central Data Entry team.
• Escalate any issues, as needed, to the R&D Quality CAPA Review Board and attend the meetings if required.
• Raise any process or system questions or concerns to the CAPA Champions Community of Practice.
• Collaborate with other CAPA Managers/Champions in the management of complex CAPAs and process related activities.
• Manage requests for assistance from the Central Data Entry team on behalf of the IO.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level