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.
Overview
Reporting to the Vice President of Quality (GXP), the Senior Director, Quality Systems and Compliance will lead the strategy for GMP quality systems and compliance programs in accordance with regulations, guidelines, and industry standards. This leadership role is responsible for overseeing the development, implementation, and maintenance of a comprehensive enterprise-level quality management system and oversees the QA Compliance team responsible for audit and inspection management and supplier qualification. The ideal candidate will have extensive experience leading and overseeing GMP quality systems and GMP compliance programs, with deep understanding and demonstrated working knowledge of CFRs, ICH guidance documents, and other regulations that govern GMP compliance during clinical development and commercialization of drug product.
Responsibilities
Full strategic responsibility for the GMP Quality System and Compliance teams, including but not limited to, the following:
Qualifications
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
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:
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Cytokinetics is an Equal Opportunity Employer
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