Associate Director Quality/QP Europe– Qualified Person

at  Cytokinetics

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 Head of Quality Europe/QP, the Associate Director/QP at Cytokinetics will oversee and perform QA aspects regarding routine Supply of Cytokinetics products in Europe and certification for the site to ensure they are completed. The candidate will provide QP support and advice to internal and external customers and will manage day-to-day quality issues as they arise at Cytokinetics. The Associate Director of QA/Qualified Person in Europe who will also serve as our back-up Qualified Person (QP) to oversee our QA activities as we continue to expand our clinical pipeline and prepare for the launch of Cytokinetics’ first commercial product. As our Associate Director, you will report to the Head of Quality Europe and will assist in ensuring batch production compliance with EU regulations and final batch release of Cytokinetics’ products. You will have end-to-end QA responsibilities of our operations in Europe, ensuring quality systems and compliance in alignment with the growth of the company and our portfolio. You will serve as a key partner with Global Supply Chain and Technical Operations, and act as an advisor to other US-based QA colleagues and senior management for GMP strategy, planning, and execution. You will be an internal lead during EU inspections and be the primary liaison with health authorities. Be knowledgeable and current with the global regulatory environment, as well as assess, and communicate impact of changes on development programs and commercial products.
The candidate will form part of the global QA team accountable for delivering operational performance against targets.

JOB REQUIREMENTS/QUALIFICATIONS:

• 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
• Travel requirements – up to 15% per annum
  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.

• Act as a named operational Qualified Person under Cytokinetics EU Manufacturer’s/Importers License(s)
• Take an active role in Cytokinetics QMS by reviewing and approving change controls, investigations, procedures and CAPAs
• Review analytical and batch documentation and certify batches as appropriate
• Attendance and input to site Quality Management Review Meetings
• Develop site QMS to be compliant with new regulations
• Create and negotiate Quality Technical Agreements
• Conduct QP audits of contract manufacturing sites and testing labs
• Review of PQRs
• Represent the Quality Assurance Department in meetings and make decisions within span of control
• Provide guidance on issues concerning QP certification
• Provide QP expertise for New Product Introduction, liaising with site Project Managers and suppliers
• Work closely with all Manufacturing sites (CMO) and distribution partners regarding Quality matters