Associate Director Quality Operations/Qualified Person
Ireland
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.
At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.
Job Overview
The role
We are seeking an experienced professional to fill the role of Associate Director Quality Operations/QP. In this pivotal position, you will oversee the compliance and quality of our Quality Operations for pharmaceutical products, ensuring that all processes meet regulatory standards. You will manage and oversee all aspects relating to Quality Systems within the Quality Operations team. In addition, you will act as Qualified Person for EU certification of product. In the role, you will act as the main contact person for Quality aspects relating to Cytokinetics partnerships in ex-EU markets as part of the companies Alliance Management activities.
Key Responsibilities:
Leadership in Good Distribution Practice (GDP):
* Monitor and assess the distribution processes to guarantee that they meet quality standards and regulatory requirements.
* Oversee activities post release of products, ensuring that all necessary documentation is accurate, complete, and in compliance with Good Distribution Practices.
Responsibilities as the Qualified Person :
* Act as the Qualified Person (QP) as defined by EU regulations, ensuring that all products manufactured and released comply with applicable quality standards.
* Conduct batch release activities, ensuring that all documentation is complete and compliant before product release.
Regulatory Liaison and Compliance:
* Serve as the primary point of contact for regulatory authorities (e.g., HPRA, EMA) regarding GDP compliance.
* Prepare for and manage regulatory inspections and audits, ensuring that all documentation and practices meet the required standards.
Quality Systems and Risk Management:
* Identify potential risks in the distribution process and develop strategies to mitigate these risks.
* Lead investigations into quality issues, deviations, and complaints, implementing corrective and preventive actions (CAPA) as needed.
* Act as Quality Operations lead for all non-conformances and Quality System records, leading activities relating to these areas. Build processes and metrics to track KPIS relating to non-conformances.
* Ensure timely and effective resolution of quality issues, implementing corrective actions as necessary.
* Act as SME and lead for team in performing Investigations and report writing
Team Development and Training:
* Mentor and develop the GDP and quality assurance teams, fostering a culture of quality, compliance, and continuous improvement.
* Oversee training initiatives to ensure all personnel are well-informed about GDP regulations, company policies, and best practices.
* Work closely with Supply Chain and Operations colleagues to ensure that there is constant focus on GDP requirements
* Drive initiatives aimed at enhancing the efficiency and effectiveness of the distribution operations, utilizing data analysis and quality metrics to inform decision-making.
* Collaborate with cross-functional teams to align quality and distribution objectives with overall business goals.
Qualifications
* Education: Bachelor's degree in a relevant scientific discipline (e.g., Pharmacy, Life Sciences, Logistics). A Master's degree or equivalent is preferred.
* Certification: Must be qualified as Qualified Person per EU legislation
* Experience: A minimum of 8-10 years experience in Quality Assurance, Quality Control and/or Quality Systems experience within the Pharmaceutical Industry
Cytokinetics is an Equal Opportunity Employer
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