Global Quality Compliance Lead — Product Complaints & Audits

cytokinetics; Ireland; On-site; EUR 103,000 - 129,000; Full time

Job summary

Cytokinetics seeks an experienced Senior Manager, Quality Compliance to lead and coordinate quality compliance activities in Ireland. The role focuses on managing the Product Quality Complaint program and ensuring readiness for regulatory inspections and audits.

The successful candidate will collaborate with Qualified Persons, Responsible Persons, Technical Operations, and cross-functional teams to align with global regulatory requirements and optimize quality processes and systems across the

Qualifications

• Bachelor's degree (BSc) or higher in a relevant scientific discipline.
• 8+ years' experience in pharmaceutical or biopharmaceutical manufacturing and quality.
• Direct experience with Product Quality Complaint handling within the US and EU is required.
• Strong working knowledge of GMP/GDP regulations and emerging regulatory trends.
• Experience working with external partners or contract organizations, including Quality oversight.
• Experience dealing with regulatory authority inspections is preferred.
• Strong investigation handling, communication, problem-solving skills.
• Ability to travel up to 10% annually.

Responsibilities

• Lead and coordinate QA compliance programs and activities.
• Own end-to-end Product Quality Complaint handling for clinical and commercial products.
• Collaborate with cross-functional teams to assess complaint events against licenses, MAH, and country requirements.
• Drive thorough investigations to determine if a product is defective.
• Monitor complaint events and prepare information for reporting to senior management and QMS improvements.
• Act as a point of contact with contract service providers in the complaint handling process.
• Support preparation for regulatory inspections and partner audits with cross-functional teams.
• Support cross-functional teams and training for audits and inspections.
• Support the Quality Risk Management program to ensure effective activities.

Education

Bachelor's degree (BSc) or higher in a relevant scientific discipline

Job description

Cytokinetics seeks an experienced Senior Manager, Quality Compliance to lead and coordinate quality compliance activities in Ireland. The role focuses on managing the Product Quality Complaint program and ensuring readiness for regulatory inspections and audits.

The successful candidate will collaborate with Qualified Persons, Responsible Persons, Technical Operations, and cross-functional teams to align with global regulatory requirements and optimize quality processes and systems across the