Director, Clinical Quality Assurance

Cytokinetics Incorporated; South San Francisco (CA); Híbrido; USD 222.000 - 260.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Stock options and RSUs

Comprehensive health, dental, vision,

Descripción de la vacante

Cytokinetics Incorporated in South San Francisco, CA, seeks a Director of Clinical Quality Assurance to lead global quality strategy for clinical development programs and ensure regulatory compliance worldwide. You will establish, maintain, and drive quality programs, SOPs, and QA systems in support of program timelines and patient safety.

You will build and lead the CQA team, oversee audits and inspections, and partner with cross-functional groups to address findings and strengthen processes.

Formación

• Bachelor's degree in life sciences with 12+ years experience in a GCP related discipline.
• Strong working knowledge of US FDA CFR and EU regulations and ICH-GCP guidance.
• Experience managing and developing staff.
• Able to develop innovative solutions and apply critical thinking.
• Able to organize and prioritize projects and CQA activities based on risk.
• Up to 10% travel may be required.

Responsabilidades

• Lead and implement GCP QA strategy, manage and develop Clinical QA staff to support and enhance quality improvement initiatives for development programs.
• Lead and implement overall GCP strategy, performance metrics, quality tolerance limits, and analytics reports.
• Proactively streamline and strengthen clinical QA processes across the organization and implement improvements in collaboration with cross-functional teams.
• Lead and ensure inspection readiness activities for internal and external entities.
• Lead and/or co-host regulatory inspections.
• Lead and oversee CQA’s vendor compliance oversight program and maintenance of GCP Quality Agreements.
• Lead and manage a risk-based audit program and maintain audit metrics.
• Manage and support internal audits of GCP processes, and quality audits of clinical vendors and investigator sites.
• Ensure CQA participation on study teams to provide GCP compliance guidance and oversight to cross-functional stakeholders to ensure adherence to FDA & global regulatory requirements.
• Identify compliance gaps and provide remediation recommendations for continuous improvement.
• Review and approve SOPs, audit reports, quality event records as required.
• Create, maintain, and adhere to department operating budget.

Conocimientos

GCP compliance

Staff management

Quality systems

Regulatory inspections

Cross-functional collaboration

Educación

Bachelor's degree in life sciences

Descripción del empleo

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.

The Director, Clinical Quality Assurance (CQA) will be responsible for managing and overseeing global clinical quality strategy for clinical development programs. The role will lead the effort to establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in an international regulatory environment. You will lead the CQA group’s effort for development and execution of quality plans, policies, procedures, and quality system elements in support of clinical programs. The Director, CQA will provide guidance on CQA related matters.

Responsibilities

• Lead and implement GCP QA strategy, manage and develop Clinical QA staff to support and enhance quality improvement initiatives for development programs
• Lead and implement overall GCP strategy, performance metrics, quality tolerance limits, and analytics reports
• Proactively streamline and strengthen clinical QA processes across the organization and implement improvements in collaboration with cross-functional teams
• Lead and ensure inspection readiness activities for internal and external entities
• Lead and/or co-host regulatory inspections
• Lead and oversee CQA’s vendor compliance oversight program and maintenance of GCP Quality Agreements
• Lead and manage a risk-based audit program and maintain audit metrics
• Manage and support internal audits of GCP processes, and quality audits of clinical vendors and investigator sites
• Ensure CQA participation on study teams to provide GCP compliance guidance and oversight to cross-functional stakeholders to ensure adherence to FDA & global regulatory requirements
• Identify compliance gaps and provide remediation recommendations for continuous improvement
• Review and approve SOPs, audit reports, quality event records as required
• Create, maintain, and adhere to department operating budget

Qualifications

• Bachelor's degree in life sciences with 12+ years experience in a GCP related discipline
• Current and strong working knowledge, interpretation/implementation United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct and pharmacovigilance operations
• Experience managing and developing staff
• Able to develop innovative solutions to issues and apply critical thinking to problem solving
• Able to organize and prioritize projects and CQA activities based on risk
• Able to effectively communicate vision and expectations to the teams
• Up to 10% travel may be required
• #LI-HYBRID

Pay Range

The expected salary range for this position based on the primary location of South San Francisco, CA is $222,480 - $259,560. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.

Benefits

• equity in the form of stock options and/or restricted stock units
• comprehensive health, dental, vision, life and disability insurance coverage
• 401k retirement benefits with employer match
• learning and wellness stipends
• paid time off

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.

Cytokinetics is an Equal Opportunity Employer