Associate Director, Quality Assurance

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.

Cytokinetics is seeking a highly motivated individual to join our team as Associate Director of Quality Assurance with responsibility for oversight of Quality Control activities. You will have the opportunity to create and ensure quality processes and systems are optimized and carried out appropriately to support GMP development and commercial activities for our first product launch!

The Associate Director, QA will be responsible for oversight of Quality Control (QC) test data in a pharmaceutical manufacturing environment, with a principal focus on data associated with stability studies and lot release. This is NOT a QC role, but a QA leadership position dedicated to ensuring the accuracy, integrity, and compliance of all QC data, processes, and records. The role functions as a key partner with Global Supply Chain and Technical Operations Analytical groups, Regulatory Affairs, and other departments to ensure all testing and data management meet regulatory and company standards.

Responsibilities :

• Provide QA oversight of QC-generated data, particularly for product stability and lot release, ensuring compliance with cGMP, FDA, EMA, and other relevant regulations.
• Collaborate closely with Technical Operations Analytical groups to ensure QC data that support stability and lot release are compliant with specifications and xxx
• Oversee all aspects of QC data including review and approval of clinical and commercial stability products, which encompasses all starting materials, drug substance intermediates, drug substance, critical components, drug product intermediates, and drug products for a clinical and commercial program
• Review and approve :

Stability protocols

Accurately reflect analytical results

Minimum qualifications :

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Pay Range :

In the U.S., the hiring pay range for fully qualified candidates is $195,300 -$227,850 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

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.

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Cytokinetics is an Equal Opportunity Employer