The Software QA Lead / Computer Systems Compliance will oversee and support implementation of software lifecycle deliverables such as validation, change management and decommissioning. Review/approve validation documentation and other computerized system lifecycle documentation assuring conformance to site and global procedures as well as ISO, QSR, GXP, and/or GAMP regulations.
The lead will routinely interact with engineers, project managers, business unit owners as well as senior personnel responsible for Non-product software (NPSW) and infrastructure as they relate to St. Louis operations.
Also responsible as the site software QA lead to represent St. Louis when globally deployed computer systems are implemented.
Lead projects as assigned with minimal supervision by coordinating, directing, and coaching cross functional team members.
Lead NPSW risk assessment efforts as needed.
Act as a subject matter expert on part 11 requirements and computer system validation (CSV).
Review and approve validation documentation ensuring conformance to site and global procedures as well as ISO, QSR, GXP, and/or GAMP regulations.
Participate in NPSW change control process for system changes, re-validation, and re-qualification initiatives.
Support supplier and internal audit initiatives related to NPSW as needed.
Represent the needs of the site for globally deployed computer systems.
Reasonable, reliable attendance and punctuality is an essential job function required for this position.
This is a Technical position requiring significant written and verbal communication skills. Strong interpersonal and negotiation skills are required. Critical and analytical thinking are a key to the successful candidate.
Good problem solving and attention to detail is required.
Key contacts (internal/external) and interfaces: Project Teams, Manufacturing Sites and Subsidiaries, Engineering Experts, IS Experts, Quality Leaders, Quality Experts.
KNOWLEDGE AND EXPERIENCE REQUIRED:
Bachelor’s Degree in an appropriate Life Science, Computer Science, Engineering discipline, or relevant previous experience.
Competence in Medical Device Development Processes and/or Computer System Lifecycle validation compliance demonstrated by relevant industry experience.
Professional Certification such as CSQE and/or 8 years minimal experience with Computerized System lifecycle.
Competence in the interpretation of GXP, QSR regulations and guidance as appropriate for computerized systems and automated business processes to achieve compliance.
Experience with determining priorities and resource allocation from a project site and corporation perspective.
Proficient in the use of general PC software tools (e.g. Windows Operating Systems Microsoft Office Products, Outlook, Excel, Access, and Word).
Experience utilizing Seapine TestTrack, Sparta Trackwise, MS Project, Mindjet MindManager, Rockwell Automation Factory Talk Pharma Suite 4.0, Perforce Software management, PTC Windchill are a plus.
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity.
A world leader in the field of in vitro diagnostics for 50 years, bioMérieux is present in more than 150 countries through 42 subsidiaries and a large network of distributors. In 2014, revenues reached €1.698 billion with 88% of sales outside of France. bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve pati...ent health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.