Senior Manager, Quality Compliance

Regulatory Toolkit; Radnor (Delaware County); On-site; USD 115,000 - 144,000; Full time

Job summary

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

Qualifications

• 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%.

Responsibilities

• 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.

Skills

Quality compliance

Regulatory inspections

Risk management

Investigation leadership

Cross-functional collaboration

Regulatory knowledge GMP/GDP

Contract partner oversight

MS Office

Travel up to 10%

Education

Bachelor’s degree in a relevant scientific discipline

Tools

Microsoft Office

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 #LI-ONSITE

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.

In line with Ireland equal pay regulations, we apply objective, gender-neutral criteria to determine compensation. We actively monitor pay equity through our annual Gender Equality Index and are committed to maintaining fair and transparent pay practices.

In compliance with Ireland pay transparency legislation, compensation for this role is based on objective criteria and is aligned with our company-wide salary register. We are committed to ensuring equal pay for work of equal value.

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.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.

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