Senior Manager, Quality Compliance

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 is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

We are seeking an experienced Senior Manager, Quality Compliance to join our growing global organization. As Cytokinetics continues progressing investigational medicines and expands availability of commercial Product into various markets, this role will ensure that quality and compliance aspects and risk mitigation are established and maintained, including product surveillance related to quality defects.

This position will lead and coordinate Quality Compliance activities across functional areas, ensuring alignment with global regulatory requirements and internal standards, and that quality processes and systems are optimized and carried out appropriately. The successful candidate will act as a key point of contact between Cytokinetics and its contract service providers, managing the Product Quality Complaint program, as well as supporting regulatory intelligence, inspection readiness, and internal/external audits.

The role reports to the Associated Director, Quality Compliance and works closely with Cytokinetics Qualified Persons, country/territory-specific Responsible Persons, Technical Operations, and other cross-functional teams.

Key Responsibilities

• Serve as a key contributor on the QA Compliance team, leading and supporting the delivery of essential compliance programs and activities
• Own the end-to-end product complaints program, overseeing intake, assessment, investigation, and resolution of both clinical and commercial products
• Collaborate with cross-functional teams to Ensure proper assessment of complaint events against MIA license, MAH, and country/territory-specific requirements, as applicable, including regulatory compliance for reporting, as well as resolve manufacturing or distribution issues
• Drive thorough investigation and analysis to determine if a product is defective
• Monitor complaint events for trends and prepare the necessary information for reporting to senior management and improvement of the QMS
• Act as a point of contact with contract service providers in the complaint handling process
• Support the monitoring of regulations and industry standards for new requirements and emerging trends and support cross-functional assessments to identify recommendations to meet such requirements or address such trends
• Support preparation of anticipated regulatory inspections (PAI, routine inspections, including those at contracted organizations), and partner audits with cross-functional teams
• Support cross-functional teams and training of team members in preparation of partner audits and inspections
• Support the Quality Risk Management program to ensure activities and processes operate effectively
• Establish and improve policies, procedures and systems that enable clear oversight of internal and external GMP activities
• Provide technical support with ad hoc investigations and/or targeted training as needed
• Develop meaningful metrics and interpret results to understand the health programs/systems in relation to other quality programs/systems
• Participate in cross-functional teams representing Quality as appropriate
• Stay current with GxP regulations, guidelines and industry practices and pro vide timely updates to cross-functional teams, as necessary
• Support internal/external audits, as needed

Qualifications & Experience

• Bachelor's degree (BSc) or higher in a relevant scientific discipline
• Minimum of 8+ years' experience in pharmaceutical or biopharmaceutical manufacturing and quality
• Direct experience with Product Quality Complaint handling within the US and EU is required. Experience in other territories is preferred.
• Strong working knowledge/interpretation of global 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 (written/verbal), problem-solving skills
• Ability to influence and collaborate effectively across all organizational levels
• Strong decision maker with the ability to utilize critical thinking to problem-solve
• Strong ability to work independently, demonstrating initiative and sound judgment
• Ability to navigate through ambiguity and identify appropriate solutions in order to progress activities
• Excellent organizational skills with the ability to manage multiple priorities effectively
• Proficiency in Microsoft Office applications
• Ability to travel up to 10% annually

Pay Range

The salary range for this role is €102,800-€128,500 gross annually. Final compensation will depend on skills, experience, and internal equity considerations.

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