Sr Analyst Quality Assurance

Johnson & Johnson Innovative Medicine•Raritan, NJ

1d•$94,000 - $151,800

About The Position

The Sr. Quality Specialist leads the robustness of investigations and approvals, ensuring timely triage, thorough root-cause analysis, and effective corrective and preventive actions. In this Quality Approver role, the specialist monitors progress, provides feedback to investigation owners, resolves stakeholder conflicts, and escalates issues to senior management when required. The position supports the Investigation Quality System Investigation Process by reviewing and approving investigation records, coaching issue owners, facilitating investigation progress, monitoring action effectiveness, analyzing trends, and providing status and metrics updates. It collaborates with stakeholders, site owners, governance bodies, and senior management; supports audits and regulatory inspections as needed; and helps sustain processes and enhance platforms. The role requires independent work across functional areas in a matrixed environment, sound risk-based judgment, data analysis, clear professional communication, and the ability to coordinate stakeholders and reach agreement on compliant investigation outcomes.

Requirements

Bachelor’s degree or equivalent.
Minimum of 6 years’ experience in a regulated field and/or equivalent experience or training in an investigations capacity.
Demonstrated experience in an investigation-related function.
Knowledge and experience with regulations and regulatory compliance issues.
Excellent communication and writing skills, including the ability to develop clear, concise professional correspondence and prepare executive summaries and reports.
Critical analytical and problem-solving skills; ability to analyze data and think strategically.
Strong organization, prioritization, and time-management skills.
Adaptability, attention to detail, and ability to build and maintain relationships and partnerships across the organization.
Ability to work independently and coordinate across functional areas in a matrixed environment.
Ability to build consensus, influence, negotiate, and collaborate with stakeholders at varying management levels.
Knowledge of Quality Management, Project Management, and/or Process Excellence concepts and practices.
Experience with CAPA systems, investigative techniques, and data-driven quality improvement.

Nice To Haves

Degree in Life Science or a related discipline.
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

Review evidence and approve closure of investigation records as a quality reviewer and approver.
Review investigation records for documentation completeness, robust root-cause analysis, and compliance with procedures.
Coach investigation owners and provide actionable feedback on best practices, system usage, and investigation execution.
Facilitate investigations and related actions, monitor progress and approvals, and address delays.
Collaborate with stakeholders to support the end-to-end investigation process.
Monitor action effectiveness and confirm that root causes are eliminated or reduced to an acceptable level.
Use data analytics and trending to identify failure modes, measure action effectiveness, and inform continuous improvement priorities.
Compile investigation and action status updates, metric reports, and trending analyses.
Work with stakeholders, site owners, governance bodies, and senior management to resolve issues and align on corrective actions; escalate risks or compliance issues as needed.
Partner with site investigation business process owners to sustain processes and support platform enhancement requests.
Participate in or support internal audits and regulatory inspections as needed.
Attend, participate in, or facilitate investigation review meetings as needed.
Perform other duties as necessary.

Benefits

Company consolidated retirement plan (pension), subject to plan terms.
Company savings plan (401(k)), subject to plan terms.
Eligibility to participate in the long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different amounts specified for Colorado and Washington residents.
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, or foster care of a child.
Bereavement Leave: 240 hours for an immediate family member and 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.