Senior Manager, Clinical Quality Compliance

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.

As the Senior Manager, Clinical Quality Compliance , you are a key member of the Clinical Quality team maintaining quality systems, audit program and representing Clinical QA in cross functional setting, and advising Cytokinetics Clinical Operations, Biometry and Drug Safety and Pharmacovigilance teams on Quality matters. This role will liaise and interface with internal and external stakeholders to assess and support GCP compliance with local ,ICH-GCP guidelines and applicable regulations to drive and maintain quality standards and regulatory compliance culture at Cytokinetics.  The ideal candidate has a quality mindset in global clinical development and oversees quality activities including but not limited to inspection readiness, internal and external audits with a proven ability to manage multiple complex projects.  You will lead, execute and manage Clinical QA activities while being an advocate to drive quality and regulatory compliance culture at Cytokinetics. 

This is an excellent opportunity to help enhance clinical quality management systems and quality culture while having a direct impact on our late and early-stage clinical trials that are the future of Cytokinetics growth!

Responsibilities

Responsibilities include Clinical Quality Assurance (CQA) Compliance to ensure Good Clinical Practice (GCP) compliance and the quality of all deliverables including:

• Maintain a risk-based clinical audit program including evaluation, audit planning and coordination with auditors.
• Manage and support internal audits of clinical GCP/GVP/GLP processes and/or routine/for cause quality audits of clinical vendors and investigator sites.
• Review, approve and track audit responses and Corrective and Preventive Actions (CAPAs) to resolution.
• Manage Quality Events and provide CQA guidance to stakeholders to drive timely resolution and completion.
• Manage and resolve GCP Quality System and Compliance issues in collaboration with internal and/or external stakeholders
• Develop and maintain GCP quality system metrics to drive consistent quality standards within the organization.
• Partner with cross-functional stakeholders to drive inspection readiness activities and support regulatory authority inspections.
• Promote continuous improvement and maintenance of quality systems in compliance with Cytokinetics SOPs

Qualifications

• BA/BS in life sciences with 8+ years’ experience or Ph.D. with 3 years’ experience in life sciences, or equivalent experience in working in pharmaceutical/biotechnology industry and/or CROs QA or compliance roles including at least 3 years in GCP discipline.
• Strong understanding, interpretation/implementation United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct and pharmacovigilance operations.
• Experience in CAPA Management and Root Cause Analysis methodologies.
• Experience with electronic Quality Management Systems and Trial Master File.
• Experience in managing GCP audits of clinical vendors/investigator sites, develop audit plans and manage an audit program.
• Audit certifications and experience in supporting US and/or EMA GCP/GVP inspections a plus.
• Up to 10% travel may be required.
• Ability to influence cross-functional teams, manage multiple priorities while maintaining clinical quality and GCP compliance objectives.
• Excellent interpersonal communication skills and strong team skills.
• Other duties as assigned.

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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications
• We will never request personal information such as banking details until after an official offer has been accepted and verified
• We will never request that you purchase equipment or other items when interviewing or hiring
• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer