Senior Quality Compliance Lead: Product Complaints & Audits

Regulatory Jobs; Radnor (Delaware County); Presencial; USD 115.000 - 144.000; Jornada completa

Descripción de la vacante

Cytokinetics is a specialty cardiovascular biopharmaceutical company focused on muscle biology and cardiac disease therapies. We are seeking an experienced Senior Manager, Quality Compliance to ensure global quality systems, regulatory readiness, and risk mitigation across the organization.

The role leads the Product Quality Complaint program, coordinates audits with contract partners, and partners with cross-functional teams to maintain GMP compliance and inspection readiness in US and EU

Formación

• Bachelor’s degree in a relevant scientific field or higher.
• Minimum 8+ years’ experience in pharmaceutical/biopharmaceutical manufacturing and quality.
• Direct experience with Product Quality Complaint handling within US and EU is required.
• Strong knowledge of GMP/GDP regulations and regulatory trends.
• Experience with external partners/contract organizations including quality oversight.
• Experience with regulatory authority inspections is preferred.
• Excellent written/verbal communication and problem-solving skills.
• Ability to influence across organizational levels and work independently.
• Proficiency in MS Office and data interpretation.
• Willingness to travel up to 10%.

Responsabilidades

• Lead and coordinate QA compliance programs and activities.
• Own end-to-end Product Quality Complaint program (clinical and commercial).
• Collaborate to assess complaints against regulatory requirements and licensing.
• Drive investigations to determine product defect status and trends.
• Monitor complaint data and report to senior management for QMS improvement.
• Coordinate with contract service providers in the complaint process.
• Support regulatory intelligence, inspection readiness, and audits.
• Provide training and cross-functional support for audits and inspections.
• Contribute to Quality Risk Management activities and policy development.

Conocimientos

Quality compliance

Regulatory inspections

Risk management

Investigation leadership

Cross-functional collaboration

Regulatory knowledge GMP/GDP

Contract partner oversight

MS Office

Travel up to 10%

Educación

Bachelor’s degree in a relevant scientific discipline

Herramientas

Microsoft Office

Descripción del empleo

Cytokinetics is a specialty cardiovascular biopharmaceutical company focused on muscle biology and cardiac disease therapies. We are seeking an experienced Senior Manager, Quality Compliance to ensure global quality systems, regulatory readiness, and risk mitigation across the organization.

The role leads the Product Quality Complaint program, coordinates audits with contract partners, and partners with cross-functional teams to maintain GMP compliance and inspection readiness in US and EU