Summary of Position
The Associate Director, CSV Quality Management Systems role should have the ability to work closely and collaborate with various business partners including internal/external customers and vendors. In addition, this role will provide QA review/oversight for GXP computer systems. This position will provide the appropriate level of QA support and validation oversight for implementation, validations, and system upgrades/modifications of the computer systems. This role will manage the administration of QMS systems and associated discrepancies for electronic GXP Systems.
Roles and Responsibilities
The Associate Director, CSV Quality Management Systems is responsible for:
- Provide quality oversight and compliance support to implement and validate electronic systems in accordance with the corporate computer system validation (CSV) procedures and requirements.
- Develop or review protocol, plans, scripts, reports etc. associated with the implementation and maintenance of computerized systems.
- Provide QA oversight during risk, Part 11 and Annex 11 and regulatory assessments
- Review changes to the validated state of the system through the change control and participate in planning and implementing changes.
- Support and review system administration maintenance procedures to ensure computer systems are in a state of control.
- Lead and support inspection readiness activities for the US and International.
- Serve as the QA CSV lead on projects including inquiries pertaining to the interpretation of the FDA and other regulatory requirements for computer system validation.
- Provide management with updates on projects, the health of the CSV process, metrics and communicate risk-based escalation issues, when applicable.
- Support resolution of project deviations/errors and provide compliant oversight to software validation projects.
- Conduct validation training with project team communicating deliverables, procedures and method of script execution.
- Maintain CSV inventory; prepare and support plans for legacy systems.
- Support internal and external audits and system vendor qualification activities; assist the lead auditor and follow-up on with suppliers on open issues.
- Provide compliant support, guidance and expertise.
- Perform other quality and computer system validation duties as assigned.
- Lead and support inspection readiness activities and act as CSV SME for regulatory inspections.
- Lead and support continuous improvement activities within Quality as needed.
- Reports to Director, Quality Management Systems & GXP Systems, Quality Assurance
Qualifications and Background Requirements
- 3-5 years of supervisory experience within CSV involving validation activities and system administration
- Bachelor's Degree in a technical discipline or related field
- Minimum of 10 + years of experience in an FDA regulated environment within a dedicated Quality CSV or product software validation role.
- Strong knowledge of regulatory compliance pertaining to software validation in QA/IT infrastructure and Enterprise Systems supporting business
- Demonstrated understanding of 21 CFR Part 11, Annex 11, FDA Quality System Regulation with the ability to assess compliance risks
- Experience in implementing large global systems such as Trackwise, MasterControl, Veeva, LIMS, ERP/SAP, etc.
- Strong working knowledge in validation methodology and software development life cycle (SDLC) principles.
- Proven ability to work in a cross-functional team environment with excellent leadership, interpersonal and communication skills. Proficient in presenting data to Management.
- Ability to influence others; excellent analytical, prioritization, and multi-tasking skills
- Excellent analytical, prioritization, and multitasking skills.
- Outstanding interpersonal relationship building and employee coaching and development skills.
- Strong communication skills with the ability to communicate cross-functionally with all organizational levels.