CALIBRE Systems, Inc., an employee-owned Management Consulting andTechnology Solutionscompany, is looking for a Clinical QA Subject Matter Expert (SME). The position will oversee the GxP computerized systems validation and provide QA oversight for a Federal Healthcare client. The individual ensures that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and client's procedures.
Essential duties and responsibilities include working closely with the Business Process Owners and IT to ensure deployment of GxP systems meets client standards, relevant regulations, such as 21 CFR Part 11 and ICH and systems are maintained in a validated state. Provide QA and compliance support and strategic direction for validation activities by:
- Participating in system implementation project teams
- Ensuring adherence to client standards during the execution of the validation activities
- Assisting with issue resolution and provide strategic direction for documentation
- Assisting with the development of system specific validation plans and strategy
- Reviewing/approving the validation deliverables
- Author/review Computerized System related Incident Reports, Investigations, Root Cause Analysis, and CAPAs
- Support the management of computerized system vendors
- Support Inspection Readiness
- Provide training on validation related topics
- Review Computerized System related SOPs to ensure client practices meet relevant regulations and follow industry best-practices.
This position may include managing staff; coaching and mentoring of junior staff with training/orientation/qualification and development plan when required.
- Demonstrated knowledge of CSV, Electronic Records/Electronic Signatures, 21 CFR Part 11, principles in the clinical research industry.
- Knowledge and expertise with Software as a Service (SaaS) systems, automated process equipment and clinical data management software in the biotechnology or pharmaceutical industry.
- Well-developed computer skills and fluent with Microsoft office applications.
- Must have the effectively balance technical expertise and understanding of the business to influence decision-making.
- Must have excellent project management skills.
- Proven ability to think critically, demonstrated troubleshooting and problem-solving skills and decision making.
- Ability to function efficiently and independently in a changing environment.
- Excellent verbal and written communication skills, including translating business needs into user requirements.
- Experience in GxP regulated industry.
- 8 years of computer-related or software validation experience with at least 4 years in quality assurance role.
- Familiarity with GxP regulations and approaches to System Development Life Cycles (SDLC) and GAMP.
- Experience validating content management systems a plus.
CALIBRE is an Equal Opportunity Employer and supports transitioning service members, veterans and individuals with disabilities. We offer a competitive salary and full benefits package. To be considered, please apply via our website at www.calibresys.com. Come join our dynamic team!