Quality Systems Senior Manager

Job Description

Job Description

What We Do :

Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the utilization of oncolytic viruses through an allogeneic cell-based delivery system. Calidi Biotherapeutics is advancing this potent stem cell and oncolytic virus combination for use in multiple difficult-to-treat oncology indications. Our team is also developing a universal cell delivery system to protect, amplify and potentiate oncolytic viruses currently in development.

Job Overview / Summary :

Responsible for the control, management and retention of GxP electronic and paper records ensuring compliance to quality objectives and regulatory requirements.

Essential Duties and Responsibilities :

• Own and administer Quality Systems including the eQMS system.
• Perform super user duties for all document quality management systems.
• Participate in system validation activities, as required.
• Ensure site documentation fully adheres to CGMP, including data integrity. Review documents submitted to ensure the correct use of templates, correctly entered metadata and document types.
• Work closely with SMEs to execute workflows and business processes that align with best practices. Provide guidance and advice on approved procedures, standardization and requirements associated with the document management system.
• Collaborate with cross-functional departments to ensure timely implementation of document change requests.
• Coordinate Change Control and Review Board meetings.
• Perform new hire orientation and training.
• Support training management, processes, and systems to ensure GxP compliance with internal policies and external regulations.
• Collaborate with department managers to develop training requirements and training plans including Read and Understand, On the Job, and Instructor Led training.
• Support validation activities for GxP systems
• Support metric tracking of documentation to ensure continuous improvement.
• Provides support during regulatory inspection
• Support internal and external audits. Ensure timely escalation to management of all applicable incidents.
• Oversee logistics and shipping of GXP product for / on behalf of Calidi.
• Implement and upload repository structure for Pre-clinical, Clinical andCMC documents.
• Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality
• Perform other duties, as assigned.

Education and Experience :

Reasoning Ability :

Language Skills :

The Perks :

Work Location :

Calidi Biotherapeutics employment provides the opportunity to work in beautiful San Diego, California only minutes from the nearest beach.

EOE and Accommodation :

We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. Calidi Biotherapeutics provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may include this information in your cover letter. If you are selected to interview for a position, you may also request an accommodation with our team directly.

Employer’s Rights :

This job description does not list all the duties of the job. You may be asked by supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description.

The employer has the right to revise this job description at any time. The job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason.