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.
Reporting to the Vice President of Quality (GXP), the Senior Director, Quality Assurance Operations will lead the strategy for GMP QA Operations for Cytokinetics and is accountable for the execution and administration of the QA program to support CMC operations in accordance with FDA, ICH, EMA regulations and guidelines and industry standards. This role will lead a QA team that is accountable for all aspects of product quality throughout the product lifecycle, both internally and in collaboration with CMOs and testing laboratories. This role will be responsible for QA related activities for clinical and commercial products including transition from development (Phase III) into commercial launch. This role is accountable for QA oversight of analytical testing, analytical method transfer and validation, process validation, and batch record review and batch disposition. The ideal candidate will have extensive experience leading GMP quality assurance activities and deep understanding and demonstrated working knowledge of CFRs, ICH guidance documents, and other regulations that govern GMP compliance during clinical development and commercialization of small molecule drug product.
Responsibilities:
Full strategic responsibility for the GMP QA Operations team, including but not limited to, the following:
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.
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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