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Director of Quality and Regulatory Affairs


Location:

Poway

Description:

Vet-Stem has an exciting opportunity for an experienced person in Quality and Regulatory Affairs to join our team. The Manager of Quality and Regulatory Affairs will manage the company's Quality Systems in addition to Regulatory Submissions and Responses to the FDA. They will ensure that the company is aligned with a quality systems approach and implement new systems in order to meet FDA compliance in the laboratory services and manufacturing areas.

Manage, maintain and improve upon the company's quality systems to ensure compliance with regulations.

Manage audit program to ensure effective closure, by working with auditees to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformities cited during audits. Auditing experience a plus.

Manage CAPA, Complaints, EM, OOT, NCMR, Deviations and Document Control for the company.

Manage QC functions for lot release for cGMP cell therapy products.

Reviews submission packages for FDA to assure correct format and content.

Manage and track all submissions to FDA including ensuring responses to FDA are prepared and submitted in a timely manner.

Requirements:

Bachelors, Masters or PhD with a minimum of 7-10 years experience in regulation of the pharmaceutical manufacturing of biologics.

Experience in maintaining and improving Quality Management Systems.

Ability to effectively advocate a strategic quality systems approach and lead the organization in compliance through the process of auditing, identifying compliance issues, communication of issues and identification of resolutions. Ability to work with other area management to assure conformance to regulatory requirements, internal processes and policies.

Experience in managing the submission of documents to FDA for new drug/biologic products with a strong understanding of GMP, GLP & GCP requirements. Experience in the management of specifically FDA/CVM procedures is a plus.

Strong time management, organizational, interpersonal, written and communication skills with the proven ability to manage and prioritize multiple projects and meet deadlines.

Strong computer skills including Word, Excel and Project Management Software in addition to relational databases and the FDA eSubmission process.

Experience working in a matrixed-reporting environment.

If you are interested in joining our team, please send your resume with cover letter to apply@vet-stem.com

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