Cytokinetics is a late-stage 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 muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.

Cytokinetics is seeking a highly motivated individual to join our team as Quality Systems Manager. 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!  You will lead various aspects of the Quality Systems, ensure compliance with company’s procedures, company policies, and regulatory guidelines.

Responsibilities

• Process controlled documents in the electronic document management system throughout its lifecycle (e.g. SOPs, Policies, Work Instructions, Forms)
• Perform formatting and editing of controlled documents prior to routing for approval
• Provide guidance and training to document owners/authors, collaborators, and approvers throughout the document management lifecycle
• Track and manage document control activities, including management of periodic reviews
• Collaborate with functional areas to determine appropriate training assignments and assign accordingly
• Support and collaborate with stakeholders for annual review of training assignments and training roles
• Monitor and drive training compliance
• Generate and analyze metrics for report out to management and cross-functional areas to ensure routine monitoring of quality system health
• Support maintenance of the electronic document management system and learning management system
• Identify and support continuous improvement opportunities within Quality Systems
• Participate on cross-functional teams representing Quality as appropriate
• Support and participate in audits and inspections, and act as subject matter expert for document management and training systems
• Other duties, as assigned by management

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

• Bachelor’s degree in a scientific field, with 8+ years experience in a biopharmaceutical, pharmaceutical, biologics, or related life sciences area, specifically with strong experience in Document Control and Training
• Must be highly organized with a strong attention to detail
• Must have advanced skills in MS Office Suite, particularly in Word document processing and formatting
• Knowledge of GXP regulations and guidelines, as it pertains to Quality Systems
• Ability to work with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple
• Ability to work in a collaborative team environment is essential, with a customer-focused approach
• Strong decision maker with the ability to utilize critical thinking to problem-solve
• Must have strong interpersonal and communication skills
• Experience writing, reviewing and editing SOPs, as well as other document types