Director, Clinical Quality Assurance

Cytokinetics; San Francisco (CA); On-site; USD 222,000 - 260,000; Full time

Job summary

Cytokinetics in South San Francisco, CA, is seeking a Director, Clinical Quality Assurance to oversee the Clinical QA department, establishing quality programs and ensuring global regulatory compliance across GCP, GLP, and GVP.

You will lead a team, develop strategies, drive risk-based audits, maintain inspection readiness, and partner with study teams to remediate gaps, with travel up to 10%.

Qualifications

• Experience in GCP/GCP-related disciplines with regulatory knowledge.
• Proven leadership in clinical quality assurance and audits.
• Ability to implement risk-based quality plans and improvements.

Responsibilities

• Develop the GCP QA organizational strategy and staff development.
• Lead and co-host GCP, GLP, GVP inspections and audits.
• Oversee risk-based audit programs and vendor/site quality reviews.
• Ensure study teams have QA oversight and remediation for gaps.

Skills

GCP regulations interpretation

Regulatory compliance leadership

Staff development and management

Risk-based auditing

Inspection readiness and hosting

Communication across teams

Education

Bachelor's degree in life sciences

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.The Director, Clinical Quality Assurance (CQA) will be responsible for the overall operation of Cytokinetics Clinical QA department. They will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in an international regulatory environment. They will lead the CQA group responsible for quality plans, policies, procedures, and quality system elements in support of clinical programs. The Director, CQA will provide guidance on CQA related matters.ResponsibilitiesDevelop the GCP QA organizational strategy, manage and develop Clinical QA staff to support and enhance quality improvement initiatives for development programsDevelop and implement overall GCP strategy, performance metrics, quality tolerance limits, and analytics reportsProactively streamline and strengthen clinical QA processes across the organization and implement improvements in collaboration with cross-functional teamsLead and ensure inspection readiness activities for internal and external entitiesLead and co-host GCP, GLP, GVP inspectionsLead and manage a risk-based audit programManage and support internal audits of GCP and GVP processes, and quality audits of clinical vendors and investigator sitesEnsure CQA participation on study teams to provide oversight and guidanceIdentify compliance gaps and provide remediation recommendations for continuous improvementReview and approve SOPs, audit reports, quality event records as requiredCreate, maintain, and adhere to department operating budgetQualificationsBachelor's degree in life sciences with 12+ years experience in a GCP related disciplineCurrent and strong working knowledge, interpretation/implementation United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct and pharmacovigilance operationsExperience managing and developing staffAble to develop innovative solutions to issues and apply critical thinking to problem solvingAble to organize and prioritize projects and CQA activities based on riskAble to effectively communicate vision and expectations to the teamsUp to 10% travel may be required#LI-HYBRIDPay Range:The expected salary range for this position based on the primary location of South San Francisco, CA is $222,480 - $259,560. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.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 OffersRecently, 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 applicationsWe will never request personal information such as banking details until after an official offer has been accepted and verifiedWe will never request that you purchase equipment or other items when interviewing or hiringIf you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [e-mail] visit our website at: www.cytokinetics.comCytokinetics is an Equal Opportunity Employer