What are the responsibilities and job description for the QA Compliance Officer position at Meet?
Overview:
We are a growing biotech organization based in the Bay Area, seeking a skilled QA Compliance Officer to lead on ensuring our QMS is compliant with GxP regulations, guidance, and industry standards. This includes managing the document management system and training program. This role is a contract-to-hire position and is a significant opportunity for someone to support and build out the QA foundation for an organization that is creating therapeutics for serious autoimmune and cancer indications, which are in clinical trials.
About the Job:
The successful candidate will have a strong background in Quality Management and Compliance, with a proven track record in managing quality compliance programs, document management, and training initiatives. You will be responsible for leading internal audits, gap assessments, and compliance initiatives to identify risks and ensure readiness for regulatory inspections.
Your Key Responsibilities:
You Will Need:
We are a growing biotech organization based in the Bay Area, seeking a skilled QA Compliance Officer to lead on ensuring our QMS is compliant with GxP regulations, guidance, and industry standards. This includes managing the document management system and training program. This role is a contract-to-hire position and is a significant opportunity for someone to support and build out the QA foundation for an organization that is creating therapeutics for serious autoimmune and cancer indications, which are in clinical trials.
About the Job:
The successful candidate will have a strong background in Quality Management and Compliance, with a proven track record in managing quality compliance programs, document management, and training initiatives. You will be responsible for leading internal audits, gap assessments, and compliance initiatives to identify risks and ensure readiness for regulatory inspections.
Your Key Responsibilities:
- Manage and maintain controlled documents, ensuring compliance with SOPs, cGMP/GDP, and regulatory standards.
- Develop, implement, and oversee the Quality Management System (QMS), including SOPs, policies, training programs, and audit readiness.
- Conduct document control tasks such as proofreading, ensuring accuracy, consistency, and compliance with terminology and formatting standards.
- Lead internal audits, gap assessments, and compliance initiatives to identify risks and ensure readiness for regulatory inspections.
- Monitor and improve training programs, ensuring personnel are compliant with regulatory requirements and company standards.
You Will Need:
- BS in Chemistry, Engineering, Biology or a relevant discipline and a minimum of 5 years of industry experience in Quality Management and Compliance across biotech/pharma in a GMP setting.
- Strong knowledge of regulatory requirements (FDA, EMA, ISO 13485, cGMP) and GxP compliance.
- Experience with QMS, DMS, and LMS software (e.g., Smartsheet, Veeva QualityDocs, Vault Training).
- Proven track record in managing quality compliance programs, document management, and training initiatives.
