GeneCoda has been engaged to identify and evaluate candidates for a Head of Technology Systems Compliance located in the Research Triangle Park, NC marketplace.
About Our Client:
Our client is an innovative, clinical-stage biopharmaceutical company developing medically important pharmaceutical products in Oncology and other therapeutic areas with unmet needs.
The Head of Technology Systems Compliance is responsible for managing all aspects of computer system validation, IT Quality Assurance and Compliance. This role works with all departments and business function areas to ensure the appropriate level of qualification and validation activities are completed, commensurate with associated system risk(s) to ensure business continuity and compliance with relevant regulations and industry guidance documents, e.g., FDA, EMA, ICH, local and national regulations. Specific assignments and activities will vary based on the priorities, needs and project deliverables. This position leads a small internal team with knowledge and relevant experience in computer system compliance to be supplemented with external resources as needed.
- Provide overall leadership for all aspects of IT Quality Assurance and Compliance throughout computer system lifecycle management, including but not limited to system selection and design, qualification, validation and/or change control management.
- Lead the overall development and implementation of applicable IT Quality Management System SOP’s and best practices, including training, implementation, and continuous improvement of associated processes.
- Lead or support the development of a SaaS Quality oversight program for all SaaS, including both clinical and commercial, GxP and non-GxP systems.
- Facilitate risk and gap analyses of existing systems and processes. Lead and / or support process improvement projects associated with key risk areas, as necessary.
- Perform and / or assist in performing software / IT supplier audits and assessments.
- Lead and / or support the investigation and documentation of applicable computer systems quality, data integrity, security incidents and issues, as necessary.
- Establish and / or support computer systems compliance metrics and routinely report the status of IT Quality Assurance and compliance activities to Quality, IT Operations, and other department / business function heads.
- Support various data quality projects associated with both GxP and non-GxP systems.
- Travel approximately 10-15% of time (domestic and international); the frequency of travel may increase for a short duration to meet critical business needs.
Education: Bachelor of Science degree in a scientific discipline, technology, engineering, or related field. An advanced, post-graduate degree is desirable.
Experience and Qualifications:
- 10+ years of experience in corporate IT Quality Assurance or Compliance and Computer System Validation in a clinical or commercial biotech/pharma company.
- Direct and recent experience associated with outsourced IT systems, Software as a Service, and Quality Systems development for a pharmaceutical or biotech company with preference to initial systems design.
- Recent experience in clinical and / or commercial IT systems and platforms is preferred.
- Strong knowledge of regulations for electronic system validation, data integrity and privacy (e.g., 21CFR Part 11, EU Annex 11, FDA/MHRA/WHO/PICS Data Integrity Guidance, HIPAA, GDPR, etc.).
- Demonstrated leadership skills in mentoring and developing staff, including direct reports.
- Ability to both strategize (i.e., see the ‘big picture’) and provide attention-to-detail and hands-on support when needed.
- Ability to influence and work effectively across the entire organization from executive leadership, department, and business function heads, to cross-functional project teams.
- Strong collaborative skills, team player mentality.
- Effective decision-making and problem-solving.
- Ability to troubleshoot, identify root causes and systematically resolve problems.
- Ability to prioritize, organize and manage multiple projects simultaneously.
- Excellent interpersonal skills.
- Excellent verbal and written communication skills.
GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state, or local law.