Director, Clinical Quality Assurance

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 managing and overseeing global clinical quality strategy for clinical development programs. The role will lead the effort to establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in an international regulatory environment. You will lead the CQA group’s effort for development and execution of quality plans, policies, procedures, and quality system elements in support of clinical programs. The Director, CQA will provide guidance on CQA related matters.

Responsibilities

Lead and implement GCP QA strategy, manage and develop Clinical QA staff to support and enhance quality improvement initiatives for development programs

Lead and implement overall GCP strategy, performance metrics, quality tolerance limits, and analytics reports

Proactively streamline and strengthen clinical QA processes across the organization and implement improvements in collaboration with cross-functional teams

Lead and ensure inspection readiness activities for internal and external entities

Lead and/or co-host regulatory inspections

Lead and oversee CQA’s vendor compliance oversight program and maintenance of GCP Quality Agreements

Lead and manage a risk-based audit program and maintain audit metrics

Manage and support internal audits of GCP processes, and quality audits of clinical vendors and investigator sites

Ensure CQA participation on study teams to provide GCP compliance guidance and oversight to cross-functional stakeholders to ensure adherence to FDA & global regulatory requirements

Identify compliance gaps and provide remediation recommendations for continuous improvement

Review and approve SOPs, audit reports, quality event records as required

Create, maintain, and adhere to department operating budget

Qualifications

Bachelor's degree in life sciences with 12+ years experience in a GCP related discipline

Current 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 operations

Experience managing and developing staff

Able to develop innovative solutions to issues and apply critical thinking to problem solving

Able to organize and prioritize projects and CQA activities based on risk

Able to effectively communicate vision and expectations to the teams

Up to 10% travel may be required

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Pay 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 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