Sr Quality Specialist/CQV

We are working with a pharmaceutical manufacturing company who is seeking a Senior Quality Specialist/CQV to support their quality systems and validation activities.This companys core mission is to drive growth and spark innovation within the scientific community, helping a mutitude of pharmaceutical companies solve some of the worlds most urgent healthcare problems.Key **Independently define and lead Quality/CSV Project.Provide technical guidance and leadership to lesser experienced team members.Complete review of previous assessments completed by third parties and established/drafted client documentation to drive development of a complete Validation Inventory List and Project Plan.Lead project in its entiretyDevelop and maintain a project plan/Gantt 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 and/or update current documents and align to Client documentation format per defined Validation Inventory List and Project Timeline.Key **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 clients 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 follow-up.Intermediate 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 youd make a good fit for this role given your background and qualifications.

Created: 2025-02-20