Senior IT Compliance Manager
General Position Summary/Purpose:
The Senior IT Compliance Manager will be responsible for driving ongoing Compliance of Quality and IT Systems, Audit Remediation, and supporting various IT client organization including but not limited to Manufacturing, Regulatory, Quality Control, and R&D business units. Collaborate with the leadership of the Pharmacyclics IT compliance programs to ensure proper fulfillment with company-wide IT compliance obligations, including 21 CFR Part 11, HIPAA, PCI, SSAE18, GDPR or other federal or state and international regulations as identified. The individual will provide support to ensure IT Change management, CAPA, Deviations, training and SOP and IT systems reviews are conducted in accordance with established policies and procedures. In addition, the individual will have hands on experience in driving Internal and External audit exercise.
Key Accountabilities / Core Job Responsibilities:
- Provide oversight and collaboration in policy development, management and enforcement of approved policies, procedures, and governance of IT Compliance (GXP, SOX and Security) programs.
- Provide guidance and oversight 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 group to support operational change control process and provide oversight and compliance approvals of project deliverables; IT change requests and IT issue reports.
- Track and ensure completion of Audit and Inspection related findings are completed on time
- Provide guidance in development and maintenance of assessment programs for IT process, people, and procedures.
- Collaborate with other stakeholders to conduct 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.
Qualifications and Requirements:
- BS/MS Degree in Computer Science, Information Technology, or related discipline with 8 years post-graduation work experience.
- 10+ years of pharmaceutical regulatory, audit and IT compliance experience.
- Excellent communication and documentation skills with strong attention to detail and well organized.
- Strong knowledge of information security governance, risk, and IT Controls compliance program,
- Deep understanding of regulatory requirements in technologically progressive Biotechnology, Pharmaceutical FDA and or SOX regulated IT environments.
- Experience with conducting risk assessment and knowledge of current industry good practice for risk assessment methodologies and tools, e.g., GAMP, NIST, ICH Q9)
- Proven people management experience, including managing of virtual and managed service partners and teams.
- Demonstrated leadership skills with ability to work and communicate effectively with Senior ITLT and executive levels
- Demonstrated strong knowledge of FDA, SOX audit procedures and IT Quality system validation best practices.
- Certification in one or more of the following areas is a plus: CQA, CMQ/QE, CISA, CISM, CRISC etc.