Associate Director Audit Planning and Risk Management job in Remote
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| Job Code: | J3P7C45ZZ3YLHG9K8YJ |
| Employer: | Daiichi Sankyo, Inc. |
| Category: | Director Clinical Research |
| Job Type: | Full Time |
| Location | |
| Country: | United States |
| State: | Remote |
| City: | Remote |
| Post Date: | 04/26/2024 |
| Description | |
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Job Description Join a Legacy of Innovation 110 Years and Counting! Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. SummaryReporting to the Head Global Audits and Compliance and in collaboration with QA leadership ensures audit planning is aligned with DSG Regulatory Strategy and that audit scheduling is based on a risk-based approach and applicable risk assessments. In collaboration with the Head Global Audits and Compliance responsible for management and maintenance of the Master Audit Schedule. Ensures that audit planning and execution meets or exceed business needs by ensuring on time delivery of the audit program. Works with QA QMS team members on tracking audit CAPA status, CAPA implementation verifications and creating associated metrics for QA reporting at councils and stakeholder meetings. Works closely with stakeholders to ensure timely resolution of audit CAPAs in collaboration with lead auditors and/or audit consultants. Responsibilities - Planning, creation, ongoing maintenance of the Master Audit Schedule:In collaboration with Head Audits and Compliance and Vendor Quality coordinate the creation of the Service Provider Audit Schedule based on vendor risk assessmentsIn collaboration with Head Audits and Compliance and PV QA coordinate the creation of the Pharmacovigilance Audit Schedule based on PV risk assessments, as well as the REMS Audit ScheduleIn collaboration with Head Audits and Compliance, GCO and RDQA coordinate the creation of the Investigator Site Audit, Document and Internal Systems Audit Schedules.Collaborate with regional heads to ensure alignment of audit strategy for global programs:Verify all conducted audits have been including onto Master Audit ScheduleEnsure all submitted Justification Forms have been reviewed by Head Global Audits and Compliance and appropriate actions takenCommunicate Audit Plan numbers to regional heads for audit assignmentsManaged docusigned audit pages to ensure inspection readinessUpdate eQMS with Master Audit Schedule and applicable Audit Plans, ensure changes are tracked and versioned - Risk ManagementSupport identification of compliance issues, signals and trends, review of eQMS reports to ensure compliance. Ensure timely escalation to impacted stakeholdersEnsure inspection readiness with routine audit, inspection data reviews and metric creation for presentation at councils and regional meetings in collaboration with regional QA Audits and Compliance LeadersParticipate in existing audits meetings, and/or develop forums for the analysis of outcomedata and the discussion of programmatic insights, implications, and strategies for improving audit quality and results.Ensure audit CAPA information in the eQMS is addressed in a timely manner (no overdue CAPAs). Provide compliance oversight metrics and trend analysis of Quality Status to global QA management and to stakeholders of internal and external functions.Ensure a consistent framework for periodic CAPA updates across the audit team to ensure that the organization is in a perpetual state of compliance in collaboration with QMS QAReport on CAPA trends, most frequent or common root causes, CAPA Implementation Verification and areas of improvement in close collaboration with regional QA leaders and internal and external stakeholders. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree Bachelor's degree in a scientific, health care or related discipline required Experience Qualifications - 7 or More Years 7 or more years of professional experience in Quality and/or Clinical Operations and/or Data Management within the Pharmaceutical Industry. required - Ability to provide interpretation and guidance for internal and external customers on GxP related regulations / guidelines (e.g., FDA, EU, ICH) and company procedures and policies. preferred - Experience with Health Authority Inspections, (e.g., FDA, HPFB, MHRA and other European regulatory agencies) required - International experience is a plus; but at minimum, experience working with diverse cultures and employees preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. | |
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