The Manager, Clinical Quality Assurance (CQA) will be responsible for:
- Participating in Study Management Team meetings and providing basic compliance related advice.
- Ensuring CQA confidential documents are filed per internal SOPs.
- Managing and/or performing clinical study related audits (e.g., Clinical Sites, Clinical Vendors, and internal clinical functional areas and systems) for compliance with Good Clinical Practices (GCP), study protocols and instructional documents, regulations and other applicable standards.
- Participating in the provision of GCP-related and Inspection Awareness/Readiness training for internal staff.
- Participating in Cytokinetics’ Inspection Awareness/Readiness.
- Assisting clinical sites conducting Cytokinetics’ studies to successfully host regulatory inspections.
- Supporting GCP and Drug Safety/Pharmacovigilance (DS/PV) related regulatory inspections at Cytokinetics.
Responsibilities include conduct of Clinical QA (CQA) daily operations as assigned and providing quality deliverables including:
- Perform day-to-day CQA activities as assigned.
- Attend Study Management Team (SMT) meetings as assigned.
- Provide basic GCP-related advice based on SOPs, regulations, regulatory authority guidance, and any strategic discussion with CQA Management (Associate Director and above).
- Manage and generate CQA metrics for internal governance meetings and CQA compliance oversight activities.
- Contribute to or draft Audit Plans as assigned.
- Conduct audits as assigned and in compliance with internal SOPs; Co-audit with new GCP auditors.
- Provide draft audit reports within timelines established in internal SOPs; incorporate feedback from management review of the draft audit report; finalize report in compliance with internal SOPs.
- Schedule and lead audit debrief meetings.
- Prepare final audit reports for internal distribution.
- Ensure CQA documents are filed in compliance with CQA SOPs and CQA Administrative Guidance.
- Assist in the creation of audit trends and audit trend reports.
- Assist in biennial review of CQA SOPs and identify the need for any new CQA SOP.
- Review GCP-related functional area SOPs during internal audits; identify any need for revision or new SOPs.
- Assist in the review of new or revised GCP-related functional area SOPs as assigned.
- Provide GCP and Inspection Awareness/Readiness training as assigned.
- Participate in Inspection Readiness activities as assigned. Support GCP-related and Drug Safety/Pharmacovigilance Inspection at Cytokinetics as assigned.
- Perform Clinical Site Inspection Preparation Audits for clinical sites conducting Cytokinetics-sponsored trials in compliance with internal SOPs and as assigned.
- May participate at the Clinical Site as the Sponsor Representative during regulatory inspections of Cytokinetics-related studies.
- Remain current in regulatory requirements and industry standards for GCP.
Qualifications:
- BS/MS/Ph.D. in science, nursing, or other education with 6+ years of experience; minimum of 3 to 5 years’ experience working in FDA-regulated clinical research including at least 1 to 3 years Clinical QA.
- Working understanding of the key requirements for compliance of clinical research and Drug Safety as described in FDA and European regulations and guidance, including ICH.
- The ability to apply regulatory requirements and provide basic information regarding the requirements.
- Able to discuss audit findings clearly, providing CQA perspective on the ranking of audit findings seriousness.
- Experience auditing Phase I-III clinical trials.
- Awareness of inspection processes and willingness to support GCP-related or DS/PV related inspections.
- Excellent writing and editing skills.
- Ability to work independently, manage multiple priorities, and execute on goals.
- Excellent interpersonal communication skills.
Now is the perfect time for you to consider a move to Cytokinetics where you can put all of your skills to maximum use. You will enjoy a truly unique culture as well as a competitive benefits program.
#J-18808-Ljbffr
