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
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Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $186,210 - $217,245 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographi
Benefits
Health insuranceEquity / stock options
Additional Information
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.
Cytokinetics · South San Francisco, CA