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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

POSITION SUMMARY:

The Sr. Quality Specialist leads robustness of investigations and approvals, ensuring timely triage, thorough root-cause analysis, and effective corrective/preventive actions. This skilled and competent Quality Approver role will support monitoring progress, provide feedback to investigation owners, resolve stakeholder conflicts, and escalate issues to senior management when required.

Investigation Quality System Investigation Process

• Execute quality reviewer/approver duties, review evidence, and approve closure of investigation records.

• Conduct investigation record quality reviews for documentation completeness, robust root-cause analysis, and compliance with procedures.

• Provide coaching and actionable feedback to issue owners on best practices, system usage, and investigation execution.

• Facilitate the progression of investigations and related actions and monitor progress and approvals.

• Collaborate with key stakeholders to support the end-to-end investigation process.

• Monitor action effectiveness and confirm root cause is 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 and provide regular investigation and action status updates, metric reports, and trending analyses.

• Collaborate 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 and to sustain processes and support platform enhancement requests.

• Participate in and/or support internal audits and regulatory inspections, as needed.

• Attend, participate and/or facilitate investigation review meetings, as needed.

• Perform other duties as necessary.

DECISION-MAKING AND PROBLEM-SOLVING:

• Ability to work independently and coordinate across functional areas driving compliance to the Investigation Global Process.

• Requires basic management skills for cross-functional interactions and coordination. Facilitates resolution of issues and able to collaborate with stakeholders at varying levels of management across multiple organizations.

• A fundamental understanding of the risk management process to engage key stakeholders and mentor colleagues to capture insights and make risk-based decisions.

• Excellent communication and writing skills demonstrated by the ability to write executive summaries and ad hoc reports promptly and clearly as well as compile and present data to other professionals.

• Requires data analytical skills to examine data and perform analysis.

• Requires decision-making skills to approve the appropriateness, effectiveness, quality and compliance of documented robust investigations, root cause analysis and corrective/preventative action plans.

WORKING RELATIONSHIPS/INTERFACES:

• Must be able to effectively operate in a matrixed environment and interact with cross functional leaders on a regular basis.

• Investigation team members – interfaces daily as needed to manage workload, interfaces weekly in team meetings.

• Business functions involved in owning investigations and delivering action commitments - interfaces as needed to address identified issues and provide guidance on established processes.

EDUCATION & EXPERIENCE REQUIREMENTS:

• Bachelor’s Degree or equivalent is required, Life Science or related discipline is preferred.

• Knowledge and experience with regulations and regulatory compliance issues.

• Minimum of 6 years’ experience in a regulated field and/or equivalent experience/training in an investigations capacity.

• Demonstrated experience in an investigation related function.

• Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence.

• Requires critical analytical and problem-solving skills, strategic thinker, and collaborator.

• Excellent organization, prioritization, and time management skills.

• Demonstrated competencies include adaptability, attention to detail, and ability to build and maintain relationships and partnerships across the organization.

• Ability to build and maintain cross-functional interactions and coordination.

• Ability to build consensus, influence, and negotiate.

• Knowledge of Quality Management, Project Management and/or Process Excellence concepts and practices.

• Other core skills: strong attention to detail, excellent time management, relationship-building, and experience with CAPA systems, investigative techniques, and data-driven quality improvement.

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)).



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: -