Associate Director Quality Operations/Qualified Person

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

Continuous Improvement:

• 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.

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.

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                    

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.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer