Business Process, Program Management, & Governance Lead

Job Title: Business Process, Program Management, & Governance Lead
Location: Raritan, NJ
Type: Contract
Compensation: $160,000.00 - $170,000.00
Contractor Work Model: Hybrid
Hours: 40.0



Leading Pharmaceutical Company located in NJ is hiring a Business Process, Program Management, & Governance Lead w/ 5+ years industry experience. If you want to be a part of this groundbreaking work, please apply!


Overview
Responsibilities

• Support the closure of CAPA by producing organizational design documentation, governance charters, RACI frameworks, and evidence packages.
• Design and establish the Global Risk Minimization Council, including charter, membership, cadence, escalation framework, and operational cycles.
• Conduct process gap analysis against current SOPs, identify gaps, and draft remediation plans.
• Revise and develop SOP content, process maps, and governance artifacts related to ARMA/CARMA implementation, tracking, and oversight.
• Develop the operating model design for the Global Risk Minimization function, including roles, responsibilities, and interfaces with regional teams.
• Coordinate with cross-functional stakeholders to align on RACI, governance, and process changes.
• Create inspection readiness materials, evidence packs for priority assets, and rapid-response protocols.
• Develop and execute implementation plans for Year 2 process rollout, including stakeholder engagement and training requirements.
• Manage project milestones, risks, and prepare status reports for leadership and governance forums.
• Assist in preparing materials for PV Compliance Committee, Global RM Council, and management reporting.

Requirements

• Minimum 4 years of experience in pharmacovigilance, regulatory affairs, medical affairs, or PV quality/compliance within a pharmaceutical or biotech company.
• Experience with CAPA management, audit remediation, or quality system governance in a PV or GxP environment.
• Ability to design governance frameworks, operating models, or organizational structures in a global, matrixed environment.
• Strong SOP/process design skills with experience drafting or revising GxP procedures.
• Proven ability to coordinate cross-functional workstreams involving multiple international stakeholders.
• Excellent written communication skills with experience producing enterprise-level deliverables.
• Comfortable operating at a hands-on execution level while engaging senior stakeholders.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.




System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.


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