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Our client is a leading research-based biopharmaceutical company. They apply science and their global resources to deliver innovative therapies that extend and significantly improve lives. Every day, colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
ROLE SUMMARY
Working in close collaboration with scientific, technical, and QA teams, the Manager, Software Validation role in R&D Solutions will manage the validation and compliance of software solutions in accordance with FDA GxP, 21 CFR Part 11, and EMEA regulations and guidances, and Pfizer Digital policies.
ROLE RESPONSIBILITIES
- Author software validation materials in accordance with FDA GxP, 21 CFR Part 11, and EMEA regulations and guidance documents and according to Pfizer Digital policies and procedures
- Lead matrixed solution delivery teams on planning, preparation, and execution of components of waterfall and Agile computer system validation packages and evaluation of compliance risk levels
- Establish a cadence of, and lead, the periodic review for all regulated software systems
- Represent R&D Solutions during regulatory agency and internal Pfizer corporate computer system audits
- Interface with Pfizer Digital Quality Assurance colleagues to ensure validation and risk management policies and procedures are being met
- Manage and maintain a roadmap related to active and upcoming validation activities, periodic reviews, SOP review, and planned audit activities
- Provide guidance on new system requirements to insure applicable regulatory requirements are included
- Direct the execution and review of GxP Test Scripts, IQs, OQs, and PQs
BASIC QUALIFICATIONS
- Bachelor’s degree with at least five years of relevant experience; OR Master’s degree with three years of relevant experience; OR Associate’s degree with eight years of relevant experience; OR Ph.D. with 0+ years of experience; OR 10 years of relevant experience with a high school diploma or equivalent
- Comprehensive knowledge of regulatory agency regulations such as GLPs, GCPs, predicate rules, 21 CFR Part 11, and EMEA guidance documents.
- Experience authoring computer system compliance risk validations, periodic reviews, SDLC, and change control, FDA GxP regulations, and 21 CFR Part 11 guidelines.
- Experience participating in internal corporate QA and regulatory agency computer system audits.
- Experience in leading matrixed teams
- Excellent verbal and written communication skills with strong attention to detail
