Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:
This is a remote and/or hybrid role available in New Jersey and Pennsylvania. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from various locations to apply and encourage you to review where this opportunity is available:
- Horsham, PA
- Malvern, PA
- New Brunswick, NJ
- Raritan, NJ
- Titusville, NJ
We are searching for the best talent for a CAPA Manager.
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.
Key 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.
Principal Relationships:
Contacts inside the company include but are not limited to:
- Various roles across Delivery Units, GCO, R&D Quality and Strategic Partnerships.
Contacts outside the company:
- Strategic partners as applicable, including CROs and study site staff as needed.
- The CAPA Manager reports into the Functional Manager in the Delivery Unit.
Requirements:
Education
- 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.
Related Experience
- 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.
General 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
Other Skills and Abilities
- 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
Required Skills:
Preferred Skills:
Analytical Reasoning, Budgeting, Clinical Trial Management Systems (CTMS), Clinical Trials, Compliance Management, Contract Management, Execution Focus, Fact-Based Decision Making, Laboratory Operations, Mentorship, Process Improvements, Project Integration Management, Research and Development, Research Ethics, Standard Operating Procedure (SOP), Technical Credibility
The anticipated base pay range for this position is :
$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
