Predicine is a Silicon Valley-based global precision medicine company that is committed to developing the first- and best-in-class liquid biopsy cancer diagnostics and precision medicine portfolio to address the unmet medical needs in global drug development. We value a culture of Integrity, Innovation, Quality, Respect, Courage, Collaboration, Caring, and Communication.
We invite people who share the same values to join us !We are looking for a passionate and results-driven Sr. Manager, Quality Management System to lead our CAPA processes, manage audits, and collaborate with regulatory bodies to ensure our products meet the highest standards. In this pivotal role, you’ll have the opportunity to own and enhance our QMS while driving continuous improvement across the organization. If you thrive in a fast-paced, environment and excel in solving complex challenges, we want to hear from you!
Responsibilities:
- Manage day to day maintenance of the quality management system but also to develop quality programs that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
- Lead CAPA processes, including root cause analysis, corrective/preventive actions, and timely resolution of quality issues.
- Hosting audits including but not limited to supplier, internal, and external audits, ensuring compliance with FDA, and ISO 13485,
- Review and approve quality records including non-conforming event reports, corrective and preventive action reports, policies and procedures, document change control, deviation reports, etc.
- Oversee the implementation and maintenance of the Quality Management System (QMS) to ensure alignment with regulatory requirements specific to medical devices.
- Collaborate with cross-functional teams to address quality issues and enhance product compliance.
- Manage document control systems, including the creation, revision, and approval of SOPs and quality records.
- Conduct risk assessments and implement risk mitigation strategies as part of the quality planning process.
- Ensure proper training and competency for employees on quality policies, procedures, and best practices.
- Identify opportunities for process improvements and lead quality-related training programs to enhance organizational competence.
- Prepare and maintain accurate records, reports, and updated SOPs related to CAPA and audits.
Nice to Have :
- Have worked at an organization supporting the quality systems infrastructure build out for a high growth Company
- Experience scaling the Quality function in a fast-paced, start-up environment is a plus.
- Experience working in a CLIA environment is a plus.
- Experience with Lean Six Sigma methodologies
Requirements:
- Bachelor’s Degree required.
- Minimum 8years of experience within the medical device, pharmaceutical, or medical manufacturing industries.
- In-depth knowledge of CAPA processes, internal and external audits, and regulatory requirements (e.g., FDA, ISO 13485).
- Strong problem-solving skills with experience in root cause analysis and risk management.
- Familiarity with quality management software is required.
Our Opportunity
Predicine is a global molecular insights company that is committed to advancing precision medicine in oncology. Predicine has developed a breakthrough cell-free DNA- and cell-free RNA-based liquid biopsy technology enabling minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and minimal residual disease and early cancer detection. The company has launched a portfolio of blood-, urine- and tissue-based diagnostic assays for oncology.
What we offer
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, for eligible employees and their dependents. Other benefits include stock allocation and 401k benefits, 1 month sabbatical after 5 years of service, lunch provided daily for onsite employees. We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status.
We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data.
