The IT Compliance Manager will be responsible for putting together a foundation of core procedures to drive the GxP IT Quality processes. The candidate needs to have a very good understanding of the Quality process as it relates to IT GxP requirements in pharmaceutical industry. Will be the Compliance IT Subject Matter Expert (SME) for GxP Software Commissioning and Qualification (C&Q) and Validation utilizing the Good Automated Manufacturing Practices (GAMP) life cycle methodology, GAMP Good Practice Guides, ISPE Baseline Guides, ISPE Good Practice Guides and the Standard ASTM E2500 ASTM E2500-13, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
Will primarily be responsible for working with IT, Functional Groups, QA functions and external vendors to identify Requirements (URS, FS, DS), facilitate the development and execution of GxP Software Test Protocols (UAT, FAT, SAT, Commissioning, IQ, OQ and PQ). In addition the role will be responsible for facilitating the development of other validation lifecycle documents such as Validation Plans, Commissioning and Qualification Plans, System Level Impact Assessments, Component Level Impact Assessments, GxP Assessments, Traceability Matrices, Risk Management Plans and Validation Summary Reports. The position will also develop, revise, format and publish standard operating procedures (SOPs), work instructions (WIs) and Change Control documentation. Additionally, the applicant will assist by supporting the IT function with Issue Management and CAPA (Corrective Action and Preventative Action) documentation and execution.
What you will be doing:
- Subject Matter Expert (SME) responsible for managing and assuring that validation deliverables for cGxP computerized systems meet the requirements of U.S. and International regulatory agencies.
- Lead validation team members in developing, managing and maintaining full SDLC validation deliverables for company's regulated computer systems.
- Review and approve Software validation and qualification documentation and provide guidance to corporate and site staff on cGxP requirements for CSV and C&Q procedures
- Collaborate with QA, IT, other business units, contractors and vendor resources to ensure successful planning, execution and delivery of GxP Software validation projects and documentation deliverables.
- Work with staff, contractors and vendor resources to develop GxP Software Validation Plans, Commissioning and Qualification Plans, System Level Impact Assessments, Component Level Impact Assessments, GxP Assessments, Traceability Matrices, Risk Management Plans.
- Perform Quality Review of validation documents in accordance with applicable regulations / guidance's, ICH, GAMP5, ISA etc., SOP's, and applicable industry standards per the business needs.
- Manage vendor audits as needed in relation to CSV activities for the IT department
- Conduct Periodic system review of GxP regulated systems for the IT department
- Contribute to the improvement of CSV methods, using compliant, efficient, and risk-based approaches.
- Lead, organize, and participate in review sessions of VMP, QAP, IQ, OQ, PQ, DDS, FAT, and SAT protocols to incorporate comments and/or changes, as applicable.
- Work closely with IT and functional subject matter experts (SMEs) to determine the content for SOPs, WIs and forms. Participate in review sessions of SOPs, WIs, and forms to incorporate comments and/or changes, as applicable.
- Work closely with IT and appropriate business functions to provide input on Change Management, Issue Management and CAPA (Corrective Action and Preventative Action) documentation and execution.
- Provide status updates on all documentation milestones and other key deliverables.
- Work with project teams to identify, analyze, prioritize, document and communicate project risks to mitigate impact to project deliverables and timeline.
- Maintain close communication with key stakeholders and business process owners to keep apprised of GxP software needs, impacts on validation, project validation status and other relevant issues pertaining to validation.
- Ability to manage and overview writing of and performance of Test Scripts.
- Experience with Quality Management Systems and Enterprise Resource Planning systems a must.
- Must possess in depth knowledge of CFR 21 part 11, Annex 11, GAMP 5 principles, 210, 211, ICH Q9/10, FMEA, GLP, GMP, GCP, GDP, SLC, ASTM E2500 and all other cGxP regulated documentation.
Experience you will need:
- Must possess the ability to quickly develop and maintain a high level of knowledge and understanding of customer's existing solutions and documentation.
- Requires a thorough understanding of CFR part 11, GAMP5, 210, 211, EU Annex 11, GxP and other industry specific pharma provisions as they apply to systems management and deployment.
- Proficiency with MS Word, MS Excel, MS PowerPoint, MS Project, MS Visio required.
- Must be resourceful with a strong customer-service orientation and commitment to provide timely and quality solutions to customer issues.
- Must be well-organized, self-directed, and a team player.
- Must be detail oriented, with strong analytical and problem solving skills, and to effectively research, troubleshoot, and solve challenging problems involving integrated systems
- Must possess a strong understanding of business processes related to pharmaceutical corporate activities.
- Assist IT department on an as needed basis
- Demonstrated ability to deal with confidential information.
- Ability to work as part of a team and independently; displays a commitment to service, be process oriented, and have a sense of urgency balanced with good judgement.