IT Quality Assurance and Compliance Senior Professional

Job Description Target Pay Rate: 100-146.67/hr salary will be commensurate with experience Job Description: The IT Quality Assurance and Compliance Senior Professional will assist in executing technology governance, IT GxP validation activities, SOX compliance activities, and the compliance processes within Information Technology. This role partners with business and technology owners to guide technology governance, in accordance to the Information Systems LifeCycle (ISLC) and in compliance with laws, mandates, and policies. This position contributes to IT oversight and validation execution for applicable GxP Information Technology systems; drafting of and adherence to, Information Technology procedures and policies; and SOX IT General controls and compliance activities. The individual may liaise with both internal and external auditors. This position reports to the Senior Director, IT Governance and can be remote from a location within the United States. Principal Responsibilities: Key responsibilities of this role include, but are not limited to: • Identifies, defines, and leads implementation of proactive, cross-organizational process improvement and change initiatives to establish and sustain an effective and efficient operational environment across regulated GxP and SOX areas. • Collaborates with QA organization to develop risk-based computerized system validation(CSV)/computerized software assurance (CSA) processes and procedures. • Ensures computer systems validation is complete per applicable procedures. • Develops and periodically assesses effectiveness of Information Technology (IT) risk framework. • Implement Risk Management policies and procedures. • Oversees and manages IT risks, dependencies, mitigation plans and execution against plans. • Ensures compliance with Information Systems LifeCycle for technology projects. • Establishes and maintains a SOC report review process within IT. • Acts as Test Lead for IT System implementations, as needed. • Reviews ISLC deliverables as IT Governance. • Conducts internal monthly IT audits for critical processes such as onboarding / offboarding. • Contributes to the IT change management process. • Develops and revises procedures as needed; assists with development and promotion of policies. • Conducts the periodic review process for IT policies and procedures. • Advises and collaborates with stakeholders on identifying, assessing, and mitigating risks and control weaknesses. • Participates in internal and external reviews, audits, inspections, and investigations. • May contribute to IT training plans, including establishment of training curriculum, assignment, records management, and compliance monitoring and reporting. • Performs other duties as assigned. Qualifications: • Minimum of 15 years of related IT experience is required. • 5-8 years of experience working in the Pharmaceutical/Biopharmaceutical industry with at least 5 years in a GxP role. • Experience in developing and managing the implementation of formal testing methodologies. • Experience with GxP and SOX audits, including working directly with internal and external auditors. • Must have experience in computer system validation, system testing, or quality oversight role. • Thorough understanding of GxP regulations, guidances, and principles, including of 21 CFR Part 11. • Knowledge of SOX Information Technology General Controls (ITGCs). • Excellent communication skills (verbal and written), excellent interpersonal skills, superior analytical and problem solving skills, demonstrated ability to apply IT in solving business problems, strong negotiation skills, strong presentation skills, keen attention to detail, exceptionally self-motivated and directed with a service orientation. • Solid understanding of quality management and continuous process improvement principles. Education: • Bachelor's degree in IT, Science, Engineering or related scientific discipline required; Advanced degree (MS, PhD, MBA) preferred. CO/NY candidates may not be considered The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma. Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available. Apply tot his job