Job Description

Job Title: QA Lead (Sr. Validation Specialist) General Summary The Validation Specialist or QA Lead will assure that validated computerized systems are implemented, maintained, and obsoleted in a state of compliance. Represent the compliance function on computerized systems projects. Assess the performance of regulated systems. Lead, drive and own projects and ensure effective communications and cross collaborations with the business on various CSV initiatives and projects. The Validation Specialist will still be executing test scripts and work on more complex projects. The role will also review and approve the work of all the other levels at a packet level. Essential Duties and Job Functions General responsibilities for this position will include (but are not limited to) the following: Apply knowledge of quality engineering principles to ensure compliance with regulatory requirements and impart that knowledge to junior level CSVS. Work closely with the SWQ Manager to collaborate with cross functional team to identify, prioritize and execute business critical quality initiatives. Work on multiple projects and meet timelines, requiring expert multitasking skills and ability to prioritize work effectively. Executes procedures, work instructions, and protocols as needed. Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data. Adhere to the Company\'s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. Create documentation to support the design and development of solutions, such as, but not limited to, user stories, business/product requirements documents (BRD/PRD), functional and non-functional specifications and documentation (FRD), acceptance criteria, product roadmaps, and to-be process flows and traceability matrices, meeting notes, gap analysis, etc. Work with end-users across the organization, to gather, understand, prioritize, and define business requirements, leveraging Medical Device, Pharmaceutical experience and best-practice methods and collaborating and seeking guidance from stakeholders. Provide quality support to development, engineering and manufacturing functions for design control and transfer activities. Position Qualifications Minimum education and experience: Bachelor\'s degree required, in engineering, computer science, or related discipline with 8+ years related experience, preferably in the medical device, pharmaceutical, or similar FDA-regulated industry, or an equivalent combination of education and experience. Required to have advanced knowledge of Quality Engineering Principals and Regulatory Environment such as: 21CFR11, 21CFR820, Annex 11, ISO 13485, 21CFR210, 21CFR212, HIPAA/PHI, SOX, GDPR Experience with the installation, configuration, validation, and maintenance of regulated software such as Quality Management Systems, Regulated Systems Expert knowledge of GAMP guidelines, 21 CFR Part 11, and FDA requirements and expectations for validated systems preferred. Strong oral, written and interpersonal communication skills. Strong leadership skills with ability to work effectively within a cross-functional team.

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