Cytokinetics is hiring a
Associate Director Quality/QP Europe

Summary

Join Cytokinetics as the Associate Director/QP in Europe to oversee QA aspects, provide QP support, manage day-to-day quality issues, and ensure batch production compliance with EU regulations. This role involves serving as a backup QP and assisting in final batch release of products.

Requirements

• Bachelor’s degree (BSc) minimum preferred
• Eligible to act as a Qualified Person under Directive 2001/83/EC
• Proficient user of MS Office Package
• Fluent in English and one other European language is an advantage
• Minimum 10 years experience in Pharmaceutical Manufacturing and related areas
• Experience in a bio-pharma/pharmaceutical start-up environment with a European footprint preferred
• Experience of hosting Regulatory Inspections and/or client/partner audits
• Deep Knowledgeable of current EU Regulations and upcoming changes
• Experience interacting, supporting and influencing at all levels across the business
• Proven ability to operate independently with initiative and minimal supervision
• Energetic with the ability to multi-task and prioritize workload
• Excellent written and verbal communication skills
• Organized and adaptable with strong interpersonal skills
• Demonstrated intuition as a result of experience working through complex situations

Responsibilities

• Oversee and perform QA aspects regarding the supply of Cytokinetics products in Europe
• Provide QP support and advice to internal and external customers
• Manage day-to-day quality issues at Cytokinetics
• Ensure batch production compliance with EU regulations and final batch release of Cytokinetics’ products

Benefits

Travel requirements – up to 15% per annum