Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

We are searching for the best talent for Complaint Quality Approver to join our External Quality team located in Horsham, PA; Titusville, NJ; or Raritan, NJ.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Brazil - Requisition Number: R-095747

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

The Complaint Quality Approver reports to the Manager, External Quality Operations and is responsible for independent, objective review and approval of complaint records to ensure investigations are complete, scientifically justified, and compliant with applicable procedures and regulations. The role confirms that risk is assessed, root cause and actions are adequately supported by evidence, required stakeholders are involved, and the complaint record can be closed with a clear and consistent outcome.

This role is applicable to the approver of complaint records owned by the virtual External Quality site, including complaints received from other company affiliates for products manufactured at the site, and ensures alignment on investigation strategy and outcome across functions and sites as applicable.

The Complaint Record Approver provides independent Quality oversight throughout the complaint investigation lifecycle and grants final approval prior to record closure. The role ensures that investigation strategies, Root Cause Analysis (RCA), and associated methodologies are appropriate, evidence-based, and involve the necessary stakeholders, including consideration of end-to-end supply chain impacts where applicable.

The approver supports investigation execution through ongoing review of progress, challenging assumptions when needed, and ensuring that new information, follow-up activities, risks, and required actions are accurately documented and addressed. Prior to approval, the approver verifies data integrity, confirms that conclusions and RCA are supported by objective evidence, and ensures trending, recurrence, and cross-site or affiliate alignment have been adequately considered.

Key Responsibilities

• Provide independent Quality review and final approval of complaint records.
• Ensure investigation strategies, RCA, and supporting evidence are robust and appropriate.
• Verify involvement of relevant stakeholders and consideration of supply chain impacts.
• Review investigation progress, address gaps, and ensure accurate documentation of new information and actions.
• Confirm risks are identified, managed, and escalated as required.
• Validate data integrity and evidence-based conclusions.
• Ensure trending, recurrence assessments, and cross-site alignment are completed.
• Coach investigation owners on CAPA best practices, system usage, and investigation quality.
• Verify all required actions and NCs are assigned, owned, and tracked before closure.

Key Interfaces

• Must be able to effectively operate in a matrixed environment and interact with cross functional local and global leaders on a regular basis.
• Complaint investigation owner(s) and cross-functional contributors (e.g., Manufacturing, QC, Engineering, Supply Chain, Packaging, MSAT).
• Other sites and affiliates (as applicable) to align investigation strategy, evidence, and outcome for site-manufactured product complaints.

Required Knowledge & Skills

• Knowledge of complaint handling, investigations, and corrective and preventive action concepts in a regulated environment.
• Understanding of cGMP, Good Documentation Practices, and applicable regulations; familiarity with U.S. and international GMP expectations for pharmaceuticals/medical products (as applicable to the site).
• Strong ability to review technical data and documents (e.g., batch records, test results, protocols, procedures) and identify gaps or inconsistencies.
• Clear written communication skills to provide precise approval rationale and actionable feedback.
• Analytical skills, including ability to interpret trends and performance metrics.
• Ability to work independently and in teams; strong organization skills to meet deadlines and manage multiple records.

Qualifications

• Bachelor's degree in Life Science or related discipline (or equivalent experience) is required.
• Minimum of 2-4 years of experience performing and/or reviewing quality investigations (complaints, deviations, nonconformances, or similar quality events).
• Experience working within quality systems and with applicable regulatory and compliance requirements.
• Demonstrated ability to write clear, concise documentation and provide professional, actionable feedback.
• Proven critical thinking, problem-solving, and decision-making skills.
• Strong organization, prioritization, and time management skills.

If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check.

#LI-Hybrid

Required Skills:

Preferred Skills:
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

The anticipated base pay range for this position is :
$94,000.00 - $151,800.00

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)).

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