We are partnered with a growing biotech organization that is seeking a Bay Area-based Manager of QA Compliance and Training to lead on ensuring the 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. The role is hybrid as well.
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.
Requirements:
- 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.
- Ability to work independently and collaboratively within cross-functional teams.
Contact:
For a confidential discussion about the opportunity, please reach out to me at 628 336 2772 or