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.
At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

JOB OVERVIEW

The role
We are seeking an experienced professional to fill the role of Associate Director Quality Operations/QP. In this pivotal position, you will oversee the compliance and quality of our Quality Operations for pharmaceutical products, ensuring that all processes meet regulatory standards. You will manage and oversee all aspects relating to Quality Systems within the Quality Operations team. In addition, you will act as Qualified Person for EU certification of product. In the role, you will act as the main contact person for Quality aspects relating to Cytokinetics partnerships in ex-EU markets as part of the companies Alliance Management activities.

CONTINUOUS IMPROVEMENT:

• Drive initiatives aimed at enhancing the efficiency and effectiveness of the distribution operations, utilizing data analysis and quality metrics to inform decision-making.
• Collaborate with cross-functional teams to align quality and distribution objectives with overall business goals.
  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.

QUALIFICATIONS

• Education: Bachelor’s degree in a relevant scientific discipline (e.g., Pharmacy, Life Sciences, Logistics). A Master’s degree or equivalent is preferred.
• Certification: Must be qualified as Qualified Person per EU legislation
• Experience: A minimum of 8-10 years experience in Quality Assurance, Quality Control and/or Quality Systems experience within the Pharmaceutical Industry
  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
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.

RESPONSIBILITIES AS THE QUALIFIED PERSON :

• Act as the Qualified Person (QP) as defined by EU regulations, ensuring that all products manufactured and released comply with applicable quality standards.
• Conduct batch release activities, ensuring that all documentation is complete and compliant before product release.