Sr Quality Specialist/CQV

We are working with a pharmaceutical manufacturing company who is seeking a Senior Quality SpecialistCQV to support their quality systems and validation activities.This company's core mission is to drive growth and spark innovation within the scientific community, helping a mutitude of pharmaceutical companies solve some of the world's most urgent healthcare problems.Key Responsibilities:Independently define and lead QualityCSV Project.Provide technical guidance and leadership to lesser experienced team plete review of previous assessments completed by third parties and establisheddrafted client documentation to drive development of a complete Validation Inventory List and Project Plan.Lead project in its entiretyDevelop and maintain a project planGantt with deliverables and resource assignments.Maintain an inventory list of documents and their status throughout the project.Development and Delivery of ArtifactsOversee additional team members and drive delivery of high-quality documentationDelivery of new documents andor update current documents and align to Client documentation format per defined Validation Inventory List and Project Timeline.Key Requirements:Travel to site in Grove City, Ohio 5 to 7 times based upon project demands.Demonstrated project leadership capabilities.Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client's organization.Ability to mentor and guide lesser experienced team members.Ability to communicate effectively with clients.Proven ability to identify areas of business expansion and report to the management team for termediate Microsoft Project capabilities.Excellent knowledge of Quality system principles; FDA Quality System Regulations (cGMP); ISO 13485 Quality system standards for medical devices or ISO 9001 Quality Management Systems and IS014971 Risk Management Systems required.Please apply in if you feel that you'd make a good fit for this role given your background and qualifications.

Created: 2025-02-21