[Hiring] Director, Clinical Quality and Compliance @Cepheid
Mar 29, 2025 - Cepheid is hiring a remote Director, Clinical Quality and Compliance. đź’¸ Salary: $140,600-200,300. đź“ŤLocation: USA.
Role Description
The Director, Clinical Quality and Compliance reporting to the Sr Director of Clinical Research or VP of Clinical Affairs will ensure that Cepheid Clinical Affairs standard operating procedures (SOPs) are compliant with current applicable regulations, laws and guidance including but not limited to the United States and Europe. This role also provides clinical compliance support for pre-market clinical studies. This position is part of the Clinical Affairs organization and will be a Remote-US based role.
In this role, you will have the opportunity to:
- Develop and oversee the design, build and execution of a robust and global clinical affairs compliance strategy and program including internal GCP auditing (i.e., TMF, SOP compliance, training, etc.), interface to the FDA and notified bodies, clinical CAPA management, and IVDR compliance across Clinical Affairs.
- Provide leadership to managers and professional associates and is accountable for the performance and results of multiple related teams.
- Apply thorough knowledge of current international requirements of GCP, GLP, FDA, ICH, CE, and applicable global regulations to ensure all Clinical Affairs department standard operating procedures (SOPs) and clinical templates are maintained in a high state of compliance.
- Ensure Clinical Affairs compliance with review process for manuscripts and other scientific communications generated by the Clinical Affairs department, in addition to responses to global regulatory submissions following US and CE IVD approvals.
- Evaluate, acquire, and implement systems to support Clinical Affairs activities (i.e., CTMS, Smartsheets, etc.) and to ensure compliance with applicable international and national standards, regulations, and guidelines (i.e., 21CRF Part 11, etc.).
- Persuade managers and leaders, while working collaboratively with a wide range of new product development and post-market surveillance stakeholder groups.
Qualifications
- Bachelor’s degree in science with 14+ years of clinical quality/GCP experience within the device industry OR Master’s degree in science with 12+ years of clinical quality/GCP experience within the device industry.
- Knowledge of US requirements and regulations related to Good Clinical Practice with hands-on experience in dealing directly with FDA and other regulatory agencies.
- Proven track record of managing successful clinical audits and defining/supporting non-conformances and CAPA.
- Ability to build strong relationships and trust with global internal and external stakeholders.
- 4+ years managing people.
Requirements
- Understanding of IVD regulations for other geographies (e.g., Asia, Africa, and Latin America).
- FDA audit (e.g., BIMO) process.
Benefits
- Comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
- This position is eligible for a remote work arrangement in which you can work remotely from your home.
- The salary range for this role is $140,600-200,300.
- This job is also eligible for bonus/incentive pay.
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| đź“Ť | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
|
Salary
đź’¸
$140,600-200,300
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Mar 29, 2025
|
| đź“Ť | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
