Description
The Senior Manager, IT Quality and Compliance is a member of the Global IT Quality and Compliance leadership team and assists the Director in executing, managing, and overseeing one or more disciplines of the IT global controls framework.
Responsibilities:
- Lead internal business and IT partners in audits, coordinating IT involvement and ensuring proper follow-up and on-time completion of IT Quality events.
- Coordinate, review, and complete contract reviews, client questionnaires, and compliance initiatives impacting IT.
- Serve as point of contact for IT audit support resources and track audit support metrics.
- Lead the management and execution of one or more components of the overall IT Quality program globally.
- Represent IT Quality on global IT projects and committees, providing subject matter expertise and oversight.
- Triage Audit Quality Events to ensure appropriate IT ownership and monitor IT QEs and CAPAs.
- Recommend proper controls for the Company's computer systems to ensure application reliability, infrastructure integrity, data integrity, and subject safety.
- Deliver technology, standards, and processes aligned with department objectives and goals.
- Partner with Corporate, QA, and IT Client Engagement to assess and leverage supplier information for validation activities.
- Lead a team by providing clear direction and expectations.
- Provide coaching and support to direct reports in creating robust development plans to grow leadership skills.
- Educate and train IT staff, business associates, and IT Project Leads on IT Quality Compliance and validation methodology.
Qualifications:
- 8 years of experience in an audit/compliance function, with 5 years focused on IT and/or Data Management.
- Experience working within a CRO/Clinical Industry.
- Strong knowledge of the audit process and audit program management.
- Prior experience in heavily regulated environments such as financial or pharmaceutical industries.
- Knowledge of regulatory compliance requirements in pharmaceutical and drug development industries in USA, EU, and APAC.
- Familiarity with various validation methodologies and their implementation in an IT organisation.
- Experience working in a team-oriented, collaborative environment.