General Position Summary/Purpose:
The IT Compliance Manager will be responsible for leading ongoing IT Compliance of IT Systems, Audit Remediation, and SOP authoring initiatives supporting various IT client organization including but not limited to Manufacturing, Quality Control, and R&D business units. The individual will provide support to ensure Change management, CAPA, Deviations, training and SOP and IT systems reviews are conducted in accordance with established policies and procedures. The individual will collect and maintain Quality metrics to support IT controls across the entire IT organization and, to support Regulatory Audits and Inspection Readiness. In addition, the individual will have hands on experience with supporting Internal and External audit exercise. The individual must have hands-on experience in the Biotechnology/Pharmaceutical FDA regulated industry. Key Accountabilities / Core Job Responsibilities:
Qualifications and Requirements:
- Lead in the identification, collection and management of Quality Metrics related to various IT control areas.
- Provide assistance in the development and maintenance of policies, procedures, and other guidance documents that provide compliance to internal and external IT controls.
- Work as part of IT compliance to support operational change control process and provide oversight and compliance approvals of project deliverables; IT change requests and IT issue reports.
- Evaluates deliverables and determines if new IT infrastructure or changes to existing infrastructure can move to production
- Track and ensure completion of Audit and Inspection related findings are completed on time
- Assist in the development and maintenance of assessment programs for IT process, people, and procedures.
- Provide assistance in performing periodic reviews by working with onsite and offshore QA and Compliance resources.
- Provide assistance conducting IT vendor/supplier audits and adherence to company policies and procedures
- Provide management oversight for managed services vendor staff working on IT Compliance and operational activities.
- Bachelor's Degree in Computer Science, Information Technology, or related discipline.
- 6+ years of pharmaceutical GxP system validation experience.
- Excellent communication and documentation skills with strong attention to detail and well organized.
- Strong knowledge of IT Controls and Audit processes and applications Knowledge of procedures and best practices related to FDA, EMA, GxP, CFR21 Part 11, Computer System Validation, and other regulations governing drug development and commercialization.
- Experience with conducting risk assessment and knowledge of current industry good practice for risk assessment methodologies and tools, e.g., GAMP, NIST, ICH Q9)
- Experience with application of CAPA methodology including structured approach for failure investigation and identification of root cause.
- Demonstrated strong knowledge of FDA audit procedures and IT Quality system validation best practices.
- Ability to assist in documenting and providing audit response to internal and external audits in a timely fashion
- Familiarity with SDLC in the FDA regulated Biotechnology/Pharmaceutical industry is necessary.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled