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, Quality Systems. 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, and ensure compliance with company’s procedures, company policies, and regulatory guidelines.
Responsibilities
- Design, develop and deploy quality systems in accordance with ICH Q10 model
- Ensure that quality systems are designed and operate as appropriate to provide support in development and commercialization for GXP areas
- Evaluate, identify, and drive continuous improvement opportunities within Quality Systems
- Assess Quality Management System processes for potential gaps to ensure compliance with regulatory guidelines
- Act as subject matter expert and provide guidance and training on quality events, including but not limited to change control, deviations, investigations, and CAPAs
- Establish and implement risk management program
- Own and drive completion of Quality Systems deviations, CAPAs, and change controls
- Lead quality governance board meetings, including deviation/CAPA, change control, and quality review boards
- Establish metrics and report out to management and cross-functional areas to ensure routine monitoring of quality system health
- Oversee and manage the electronic quality management system, including workflow configuration and upgrades, as needed
- Be the SME and represent Quality on cross-functional teams
- Participate in audits and inspections representing Quality Systems
- May supervise employees, consultants/contractors, and interns
- Other duties, as assigned by management
Qualifications
- Bachelor's degree in a scientific field, with 10+ years experience in a biopharmaceutical, pharmaceutical, biologics, or related life sciences area and relevant Quality Systems experience
- 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 effectively with various technical groups and a strong working knowledge in the following disciplines: API or DP manufacturing, analytical development/QC
- 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
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.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
