Director, Quality Systems

Cytokinetics•South San Francisco, CA

2d•$225,000 - $262,500•Hybrid

About The Position

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 of Quality Systems will be responsible for the overall operation of Cytokinetics Quality Systems and will provide leadership for the quality management system, document control, and GxP training groups. This role will provide strategic direction, leadership, and development for these groups to ensure that all aspects of pharmaceutical quality management systems (QMS), controlled documentation, and training programs are effectively established, implemented, and maintained in accordance with cGMP regulations and industry best practices. The Director of Quality Systems will serve as a key advisor on QMS-related matters and ensure quality system processes support business objectives, regulatory compliance, and inspection readiness.

Requirements

Bachelor's degree in life sciences with 12+ years’ experience in the biopharmaceutical industry, including at least 7 years of experience leading Quality Systems within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industry.
5+ years of progressive people-management experience including leading, mentoring, and developing Quality professionals.
Demonstrated leadership with effective communication skills and an ability to deliver results through teamwork.
Strong direct experience with Quality Management Systems, including CAPA, Change Control, Deviations, Continuous Improvements and Quality Risk Management.
Must think critically and be able to make decisions independently, determine appropriate resources for problem resolution, and have strong organizational and planning skills.
In-depth knowledge of Quality principles, concepts, industry practices, and standards.
Demonstrated ability to execute strategic and tactical objectives provided by senior leaders both within and outside of Quality.
Able to effectively communicate vision and expectations to the teams.

Nice To Haves

Veeva Quality Vault experience preferred.
Experience in a global, multi-site, or international GxP environment preferred.

Responsibilities

Provide strategic roadmap for the Quality Systems organization, including oversight of quality management system, document control, and GxP training groups, oversee personnel performance management, mentoring, and career development.
Lead and develop teams responsible for document control, GxP training administration, and quality system processes, ensuring effective execution and continuous improvement.
Acts as Business Process Owner of the QMS.
Ensure Quality Systems and processes are maintained and modified regularly to ensure best practices.
Ensure Quality Systems support compliance with applicable FDA, EMA, ICH, GxP, and other relevant regulatory requirements.
Oversee the document control program, ensuring the effective management, review, approval, issuance, revision, archival, and retrieval of GxP documents and records.
Oversee the GxP training program, ensuring training curricula, assignment, completion, effectiveness, and compliance requirements are met across the company.
Collaborate with IT to implement updates/enhancements to the eQMS and ensure effective system support.
Lead company-wide quality systems projects across various departments.
Work with GxP functional leaders to implement processes and systems that enable the business to operate effectively. Provide process analytics and oversight on a continuous basis to enforce requirements and meet regulations.
Monitor the entire quality system to ensure that acceptable levels of performance are maintained.
Manage continuous improvement project as required.
Establish and report on appropriate metrics and dashboards to monitor overall quality system health and facilitate quality review board and management review.
Review and approve cGMP records and documents as required.
Develop and manage goals and corresponding budget in alignment with company vision and goals.
Work on complex problems that may have implications across functions, apply strong judgment in resolving problems and make recommendations.
Lead inspection readiness activities related to Quality Systems.
Lead, mentor, and develop Quality Systems personnel and functional subject matter experts.
Recruit talent and build a high performing team, mentor, and coach colleagues.