Associate Director, QA Computer Systems Validation
Associate Director, QA Computer Systems Validation
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 hare strategic responsibility for the QA CSV / CSA 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 / CSA strategies
Actively support the CSV / CSA functional strategies and multi-year roadmap and actively take part in developing parts of the strategy
Lead internal and contract resources to manage CSV / CSA activities and ensure adequate support to meet business needs
Participate in global/enterprise wide GxP-CSV / CSA 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 / CSA 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 / CSA 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 / CSA compliance guidance identify issues and support continuous improvement
Perform CSV / CSA 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
Bachelors 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 TraceLink 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
Pay Range:
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 ourGeneral Data Protection Regulation (GDPR) policyPRIOR 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.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain () and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
We do not conduct job interviews through non-standard text messaging applications
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
If you are unsure about the authenticity of an offer or if you receive any suspicious communication please contact us directly at
Cytokinetics is an Equal Opportunity Employer
Required Experience:
Director
Employment Type
Full-Time
