
Senior Analyst, Business Process Quality
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: Titusville • New Jersey • United States
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Salary
💰 $94,000 - $151,800 per year
Job Level
About the role
- Serve as PQM process owner for selected QMS processes, including Internal Audits.
- Provide back-up support for other systems such as NC/CAPA, Change Control, Document Management, and Training.
- Assume additional ownership of tactical support systems over time (e.g., COMET STAR user), ensuring compliance, system access, and oversight.
- Actively participate in councils and forums related to QMS processes.
- Continuously improve processes and systems to enhance efficiency and effectiveness.
- Support Quality Review Meetings, metrics, and dashboards for PQM and TDS.
- Provide budget support for PQM, including headcount oversight, LRFP, and BP planning (currently for PQM-base and ECSQ), in alignment with other team members.
- Support onboarding and training of new team members as well as document management and training activities to maintain PQM’s operational continuity.
Requirements
- Bachelor’s degree required, preferably in Pharmaceuticals, Chemistry, Engineering, Sciences, or a related field.
- Proven experience in a regulated industry (pharmaceuticals, medical devices, biotechnology), preferably in Quality Assurance or Quality Engineering.
- Experience in supporting or leading audits, NC/CAPA and/or change control activities.
- Familiarity with budget and business support activities, including relevant systems and tools.
- Strong written and verbal communication skills, with the ability to clearly present quality risks, decisions, and recommendations to cross-functional partners.
- Demonstrated ability to manage multiple priorities, work independently, and adapt in a dynamic environment.
- Global mindset with collaboration and relationship-building capabilities.
- Ability to identify, influence, and implement effective solutions.
- Preferred: Experience in managing internal and external audits, including preparation, participation, and response development.
- Knowledge of Business Process Management, Six Sigma, compliance management, and financial planning.
- Technologically savvy and data-driven approach.
Benefits
- Retirement plan (pension)
- Savings plan (401(k))
- Vacation – 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees in Colorado – 48 hours per calendar year; for employees in 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management System (QMS)Internal AuditsNC/CAPAChange ControlDocument ManagementTrainingBusiness Process ManagementSix SigmaFinancial PlanningQuality Assurance
Soft Skills
written communicationverbal communicationrelationship-buildingcollaborationadaptabilityindependenceprioritizationproblem-solvinginfluencepresentation skills