Complaint Quality Approver

Johnson & Johnson • Titusville, PA

3d • Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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.

Requirements

• 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.
• 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.

Nice To Haves

• 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)

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.

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