Senior QA Validation Engineer

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.

Duties:

• Provide quality oversight to CSV projects for implementation and maintenance of computer systems.
• Perform risk assessments with functional teams to assess system risks and develop mitigations.
• Work with CSV lead to determine CSV deliverables.
• Provide input to CSV documentation and oversee the execution of qualification/validation activities.
• Review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports).
• Participate in vendor assessments and/or audits.
• Manage and/or lead CSV routine and complex audits including but not limited to internal processes, vendors and business partners.
• Work closely with the QA and other functions to provide expert CSV compliance information, manage identified issues, and support continuous improvement.
• Perform CSV inspection readiness preparations and/or directly support regulatory agency inspections.
• Assist in the coordination of response to any findings as applicable. Update and/or create computer system related policies, procedures, templates, forms, etc.
• Provide input to GxP assessments for 21 CFR Part 11 and Annex 11 requirements.
• Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations.
• Review and approve computer system change controls, deviations, and CAPAs

Education Required:
Master’s degree or foreign equivalent in Regulatory Affairs for Drugs, Biologics and Medical Devices or related field

Experience Required:
8 years of experience as Validation Engineer or related occupation

Special Requirements:
Must have at least 8 years of prior work experience in each of the following:

• Implementing GxP computer systems such as Quality, Clinical, Regulatory in compliance with company validation policies, procedures and 21 CFR Part 11, GAMP5, Annex 11 electronic record/electronic signature, and data integrity requirements.
• Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).
• Compliance oversight using guidance and regulations from health authorities such as FDA, EMA, and MHRA.
• Provide inputs and assessments for GxP computer systems risk and its impact to define validation process.
• Audit suppliers to ensure they are compliant with SOPs and health authority regulations.
• Provide inputs to CSV documentation and execution of qualification and validation activities Data migration deliverables such as data migration plan and summary report.
• Computer systems change controls, deviations, and CAPAs using Quality Management System.

Pay Range:

In the U.S., the hiring pay range for fully qualified candidates is $180,349 - $206,300 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

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.

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