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.
Reporting to the Director, QA Computer System Validation (CSV), the Associate Director, CSV is responsible for compliance oversight of computer system validation projects as part of the quality assurance team. This role will share strategic responsibility for the QA CSV function to support cross-functional and QA goals for GXP systems and deliver results for corporate initiatives, as well as independently drive and own multiple complex CSV-related projects in partnership with multiple cross-functional leaders.
Responsibilities
- Provide leadership and oversight for implementation of GxP computer system validation lifecycle and related QA-CSV strategies
- Actively support the CSV functional strategies and multi-year roadmap, and actively take part in developing parts of the strategy
- Lead internal and contract resources to manage CSV activities and ensure adequate support to meet business needs
- Participate in global/enterprise wide GxP-CSV projects and contributes to computer system validation working groups and strategies
- Manage risk assessments with functional teams to assess system risks and develop mitigations
- 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
- Interact regularly with members of QA and other GXP functions to provide expert CSV compliance guidance, identify 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 guidance and expertise on the validation approach in compliance with regulations to project teams as necessary
- Lead new system selection processes including requirement gathering, RFP development, and software vendor selection
- Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations
- Identify and implement process improvements against industry best practices, regulatory guidelines and requirements
- Review and approve computer system SOPs, change controls, deviations, and CAPAs
Qualifications
- Bachelor’s degree in engineering, science or equivalent technical discipline with 10+ years of experience in quality assurance, computer system validation/qualification, or related areas
- Experience with systems such as Veeva Vault eQMS, Veeva eTMF, SAS, ERP, Trace Link, Oracle Fusion
- In depth knowledge of CFR 21 Parts 11, GAMP5, Annex 11 and data integrity requirements, standards and guidelines
- Strong background and understanding of EMA, MHRA, FDA and other regulations
- In depth knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP)
- Detail-oriented, well organized, and able to assume responsibility for multiple projects independently
- Experience in authoring/reviewing/approving validation documentation
- In depth knowledge of software development lifecycle (SDLC) model
- Knowledge in validation practices of various computerized systems (configurable software, non-configurable software, off-the-shelf software)
- Data migration experience
- Experience with vendor audits
- 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, and the ability to work with multiple cross-functional teams
Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
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.Salary Pay Range$185,000—$226,000 USDOur 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
