Operations Effectiveness, Manager
IQVIA · Parsippany, NJ · 1 mo ago
RemoteRemoteManufacturing$79k–$197k/yrFull-time
About the role
The Operational Effectiveness Manager develops, implements, and sustains the IQVIA Channel & Specialty Data Services (CSDS) Quality Management System (QMS), ensuring products and services meet customer, regulatory, and audit requirements. They lead quality assurance initiatives, manage third-party audits, conduct and oversee internal audits, and drive continuous process improvement.
Responsibilities
- Develops, oversees, and monitors implementation of quality standards, procedures, and controls
- Conducts and manages internal audits of QMS procedures, work instructions, and job aides with Process Owners
- Led external audits including SOC 1 Type 2, SOC 2 Type 2, and other compliance audits
- Coordinates with external auditors on audit scope, timelines, and requirements
- Oversees internal audit readiness and communication across the organization
- Pairs with Process Owners to provide required documentation and audit evidence
- Develops and implements corrective action plans based on audit findings and investigations
- Maintains current knowledge of regulatory requirements and industry best practices
- Recommends and implements new or improved procedures and processes
- Collaborates with cross-functional teams to resolve quality issues and identify root causes
- Tracks corrective actions and process gaps to ensure timely follow-up and closure
- Led initiatives to address and close quality gaps
- Drives continuous improvement initiatives using Six Sigma, Lean, and Kaizen methodologies
- Participates in and may manage responses to customer RFPs and IT security assessments
Qualifications
- Bachelor’s degree in business, technology, or a related field, or equivalent experience
- Minimum of five (5) years of relevant experience, preferably within a Quality Management System (QMS)
- Strong analytical, critical thinking, and problem-solving skills
- High attention to detail and commitment to quality control
- Proven ability to lead projects and drive initiatives to completion
- Strong written, verbal, and presentation skills
- Ability to effectively engage stakeholders across all levels, including Executive Management
- Proven ability to learn, apply, and expand subject matter expertise
- Experience with process and data analysis methodologies