Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
The Manager, Clinical Quality Assurance (CQA) will be responsible for:
• Participating 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.
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
