Senior Manager, Quality Compliance
€102.8k - €128.5k per yearCytokinetics
Cytokinetics seeks a Senior Manager, Quality Compliance to lead quality and compliance activities across the organization. The role manages product complaint programs, ensures regulatory alignment, and coordinates with cross-functional teams and external partners to maintain quality standards and mitigate risk.
Responsibilities
- Lead and support delivery of quality compliance programs and activities across functional areas
- Own end-to-end product complaints program including intake, assessment, investigation, and resolution
- Assess complaint events against regulatory requirements and drive compliance reporting
- Monitor complaint trends and prepare data for senior management and quality system improvement
- Act as key contact with contract service providers and support regulatory inspection readiness
Requirements
- Bachelor's degree or higher in relevant scientific discipline
- Minimum 8+ years pharmaceutical or biopharmaceutical manufacturing and quality experience
- Direct product quality complaint handling experience in US and EU markets
- Strong knowledge of global GMP/GDP regulations and emerging trends
- Experience with external partners and contract organization quality oversight
- Excellent investigation, communication, and problem-solving skills
- Ability to influence and collaborate across organizational levels
Compensation: €102,800-€128,500 gross annually
Vacancy posted 7 days ago
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