Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing next-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. With an unmatched understanding of muscle biology and mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Working collaboratively, Cytokinetics’ dedicated employees are focused on advancing novel mechanism therapeutics to dramatically improve the lives of patients. With purpose and passion, we have committed to make an important impact on serious medical illnesses.
This position will report to the head of Quality Assurance, with primary responsibilities around collaboration on the ongoing development of compliant Quality Systems; monitoring overall data integrity; and oversight and assessment of vendor and internal GxP computerized systems, processes, and tools including those used for U.S. and worldwide clinical trials at all phases.
The position level will be assessed based on the candidate’s level of experience.
- Collaborate with IT, Biometrics, CMC, QA, CQA colleagues and other internal customers to determine overall Quality System and process requirements, assess risks, and develop processes for electronic systems which support GxP activities and clinical trials across all phases of the product lifecycle
- Work with QA, IT, consultants/contractors, vendors, and internal customers to assess and resolve compliance and quality issues related to:
- server environments, installation, configuration, integration, and testing of computerized systems
- Electronic Data Capture (EDC) and Interactive Response Technology (IRT) systems used in clinical studies
- data integrity and data-chain-of-custody processes
- Conduct and manage audits of GxP software and services vendors, as well as internal computerized system or project-based or study-based audits
- Provide Change Control guidance/oversight by working with internal groups and contract sites, assist in determining change proposal requirements and assist in drafting implementation plans
- Assist in developing and review/approval of computerized system/data integrity assessment, validation, administration and operation documents
- Oversee activities, educate, and serve as a resource for personnel seeking information on FDA/ROW regulations, guidelines/guidances and quality practices associated with:
- GxP computerized systems
- Clinical study EDC and IWR systems
- Data handling best practices
- Data integrity best practices
- Electronic systems/electronic signatures requirements
- Track metrics, and analyze compliance issues and trends to improve overall compliance of Quality Systems
- Participate in project team meetings, department meetings, and other meetings as applicable
- Maintain a thorough knowledge of appropriate regulations and standard operating procedures, and recommend/initiate SOP updates and improvements as appropriate
- Participate in the development and presentation of training on SOPs, regulations and quality concepts
- Assist in hosting regulatory agency inspections
- Perform other related duties as assigned from time to time based on company needs.
- A minimum of a bachelor’s degree in a STEM discipline
- 7+ years’ experience in a biopharmaceutical, pharmaceutical, biologics, medical device, or related life sciences area with experience in Quality, Compliance, and/or GxP IT
- The ability to work in a collaborative team environment is essential
- A solid understanding of the requirements for the assessment, testing and control of GxP computerized systems used at various phases of clinical development
- The ability to utilize critical thinking to problem-solve; assess risk to subjects/patients, study integrity, data integrity and overall quality and scientific validity; and as the basis of decisions is essential
- Must have strong analytical and interpersonal communication skills
- Experience writing, reviewing and editing SOPs, specifications, and validation documentation as well as other document types
- Experience with various types of GxP electronic systems (i.e. document control systems, statistical software, safety reporting systems, clinical study management systems, etc.), as well as typical business software (Microsoft Office applications, etc.)
- Knowledge of pharmaceutical regulations within the US (FDA) and Europe (EMA) required; additional knowledge of other ROW regulations a plus
Now is the perfect time for you to consider a move to Cytokinetics where you can put all of your skills to maximum use. You will enjoy a truly unique culture as well as a competitive benefits program.