Quality Systems Senior Manager

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:

• Bachelor’s degree Life/Health Sciences preferred.
• Minimum 5 years of experience in pharmaceutical-based GMP manufacturing operations, including at least 2 years of experience with Electronic Document Management Systems, specifically related to GMP document control.
• Excellent knowledge of current US and ex-US regulations and guidelines.
• Subject matter expertise in Document Management in a regulated environment.
• Proficient working with Microsoft, Adobe Acrobat, Sharepoint, Box, EDMS, Smartsheet.
• Good organization and planning skills.
• On-site and electronic filing and archival of documents and creating inventory.
• Strong oral and written communication skills with the ability to work across all levels in the organization.
• Ability to work independently and perform detail-oriented work with a high degree of accuracy.
• Work experience in small startup, Self-starter.
• Proficiency in document control software and tools, including experience with electronic Document Management Systems (eDMS), SAP, Sharefile, Smartsheet and general office software (e.g., Microsoft Word, Excel, Adobe).
• Experience in drafting, updating, and managing SOPs, COs, training records, product item masters, and labeling in a regulatory context.
• Project management experience, with the ability to participate in and/or lead projects, prioritize tasks, and work efficiently under pressure to meet deadlines.
• Experience in process improvement and risk management, including the identification of gaps and bottlenecks, implementation of corrective actions, and development of processes to enhance document control efficiency and accuracy.
• Familiarity with industry standards for document control, including document formatting, naming conventions, and lifecycle management.
  
  

Reasoning Ability:

• Ability to define problems, collect data, establish facts, and draw valid conclusions.

Language Skills:

• Strong communication skills, with the ability to articulate complex issues clearly to both technical and non-technical audiences, and to collaborate effectively with cross-functional teams and management (required).
• Ability to read and understand technical procedures

The Perks:

• Competitive Total Rewards package
• Daily snacks and beverages
  

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.