A Quality Management leader and a pragmatic professional with an open and communicative approach with the ability to develop teams as well as effective working relationships with stakeholders at all levels who enjoys being in a position with an international reach. Considered a flexible, persistent and resourceful Quality Management professional with a strategic mindset analyzing the quality and, operations processes from a systemic perspective with the ability to review business contractual documents, workflows, and SOPs – with the goal of identifying gaps and planning Continuous Improvement (CI) initiatives relating to quality, safety, and day-to-day operations. Proactive management style relying heavily on data-driven trends and analyses and a “system of engagement” that rallies around multidisciplinary teams to contribute to overall quality performance in an endless search of more efficient ways to keep up with ever-changing regulations.Subject Matter Expert (SME) in understanding Quality's role and significance to the GxP and Pharmacovigilance processesExcessive knowledge and application of global regulations and guidelines in relation to the medicinal products industryA proven leadership record and of track record working with Quality Assurance in an international pharma environmentExtensive experience in clinical trials, licensure and lifecycle management of products, and global GxP and inspectionsExperience with large stakeholder management and reporting to senior management teamsRobyn's management experiences is multidimensional and an integral part of the successes across all functional units.
Storm Consulting, Llc
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Quality Assurance ConsultantStorm Consulting, LlcChapel Hill, Nc, Us
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Quality And Compliance ConsultantMq&C Consulting, Llc Aug 2022 - PresentRaleigh-Durham-Chapel Hill AreaPost-approval lifecycle management Assist in creating complaint processes, including medical device reporting (MDR) to comply with 21 CFR Part 803, and improving complaint investigations.Improve document control systems, including compliance with 21 CFR Part 11 for electronic signatures and electronic record-keeping.Improve CAPA processes, life-cycle management, and effectiveness check activities.Review of current quality system and recommend appropriate updates to ensure compliance and audit preparedness.Review and updates of Risk Management (Risk Analysis) Design FMEA, Use FMEA, Process FMEAInvestigational writing relating to complaint trending data analyses and failure modes of medical devices, root cause analysis (Fishbone, 5 Whys, Pareto).
Frequently Asked Questions about Robyn Mclean
What company does Robyn Mclean work for?
Robyn Mclean works for Storm Consulting, Llc
What is Robyn Mclean's role at the current company?
Robyn Mclean's current role is Quality Assurance Consultant.
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