Associate Director, QA Computer System Validation

Cytokinetics

6 days ago

3.0 on Glassdoor

South San Francisco, California

Hybrid

Full Time

Senior

0 applicants

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About this role

The Associate Director, CSV is responsible for compliance oversight of computer system validation projects within the quality assurance team, leading strategic initiatives for GXP systems and driving complex CSV-related projects.

Skills

Qualifications

Bachelor’s degree in engineering, science or equivalent technical discipline10+ years of experience in quality assurance, computer system validation/qualification, or related areasExperience with systems such as Veeva Vault eQMS, Veeva eTMF, SAS, TraceLink, Oracle FusionIn depth knowledge of CFR 21 Parts 11, GAMP5, Annex 11 and data integrity requirements, standards and guidelinesStrong background and understanding of EMA, MHRA, FDA and other regulations

About Cytokinetics

cytokinetics.com

Cytokinetics is a late‑stage biopharmaceutical company focused on discovering and developing potential medicines for people with diseases of impaired muscle function. The company translates advances in muscle biology into clinical‑stage therapies aimed at improving cardiac and skeletal muscle performance and the healthspan of affected patients. Cytokinetics advances a pipeline of small molecules and modulators through clinical development, often collaborating with partners to accelerate development and access. Their expertise in muscle mechanobiology and clinical programs positions them to address unmet needs in neuromuscular and cardiovascular disorders.

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