Job Title

Title: Manager, Site ComplianceAbout the role: Step into a crucial role within a large medical device company as the Manager of Site Compliance. We are in search of an experienced leader to lead all site Quality regulatory compliance activities, play a pivotal role in maintaining the effectiveness of the Quality Management System (QMS), and ensure the effectiveness of internal and external audit programs.Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly.Key Responsibilities:Lead the strategic development and implementation of the Internal and External Audit cGMP QA System for drug/device products.Establish and manage a qualification/certification program for Internal/external auditors.Collaborate with SMEs to conduct external audits on suppliers, laboratories, and third-party manufacturers.Ensure timely completion of corrective actions stemming from internal or external audits, and evaluate the effectiveness of CAPAs.Coordinate and chair monthly QMS Metrics Meetings and annual Management Review meetings to monitor the effectiveness of the Quality Management System (QMS). Qualifications:BS/BA degree in a relevant scientific disciplineMinimum of 5+ years of relevant experience in Medical or Pharmaceutical Industry5+ people management experienceVeeva Vault experienceExperienced leading FDA or regulatory inspectionsPreferred experience: Six Sigma Green Belt (ASQ), (CQA) / Conduct QMS audits against standards and regulations such as 21 CFR 210 / 211 / 820 and ISO 13485 / 9001