Director of Quality Assurance

Company :

Elixir Associates are currently partnering with an exciting Clinical Stage Biotech based in Southern California company who are looking for a QA Director - GMP / CDX, as they build out their QA department.

About The Job :

The Quality Assurance Director GMP / CDX performs QA responsibilities associated with the development, regulatory approval, technology transfer, manufacture, testing and release, stability, and storage / distribution of drug products and companion diagnostics.

The Quality Assurance Director applies scientific education, training, and industry experience to interpreting and systemizing regulatory requirements and industry best practices to implement and manage phase-appropriate compliance of drug / diagnostic development and use.

The Quality Assurance Director GMP / CDX works within the QA team to continuously facilitate a vibrant quality culture of engaged and motivated staff maintaining strong working relationships within the organization and with external partners.

Key Responsibilities :

• Lead QA activities associated with development, manufacture, testing, and disposition of drug substance, drug product, and in-vitro diagnostic assays.
• Lab Quality Assurance : Verify that IVD development efforts adhere to Design Control requirements and that all aspects are appropriately documented.

Ensure that systems are established for functional Quality Control of records for which each function is responsible. Confirm completeness, approval, maintenance, and audit-readiness of medical device records (DHRs, DMRs, and DHFs).

• System Owner and System Administrator of Veeva QMS : Maintain the validated state, user access and security management, release management, functional enhancements and configuration changes, reports and dashboards, document and system change control, and routine audit trail reviews.
• Plan, conduct, report, and follow-up on internal and vendor audits.
• Maintain and improve the QMS to ensure that the systems employed are flexible and phase-appropriate, enable the manufacture of products for clinical and commercial use, and meet all necessary cGMP and regulatory requirements.
• Work closely with other departments to facilitate actions and maintain compliance with current systems for change controls, CAPA, Deviations, complaints, and internal GxP audit observation follow-up.
• Maintain a strong culture of continuous improvement. Manage systems and processes to measure adherence to the QMS, highlighting areas of risk and providing support to area owners to improve and reduce risk.
• Build relationships with internal departments, regulators, consultants, and external vendors to support the development and growth of the business.
• Use quality tools and techniques to perform and document root cause investigations, evaluate and resolve quality issues, and enhance continuous improvement.
• Update, maintain, and improve quality management system procedures and documentation.
• Perform data analysis, prepare quality trend / metrics, and report results to QA leadership.

Required Experience :

• BS degree in a scientific discipline required.
• Minimum of 5 years of QA experience working in the biopharma and IVD industries. Experience working in mAB / IVD manufacture or laboratory environments is a plus.
• Superior knowledge of international GMP (biologic and medical device / IVD) regulations, guidance, and industry best practices.
• Strong analytical and problem-solving skills.
• Able to build and maintain effective and credible relationships with key stakeholders and across all areas of the business.
• Excellent interpersonal and communication (written and verbal) skills.
• Experience working in a start-up organization with a high degree of agility and change is preferred.

Salary & Compensation :

Base Salary

Targeted Yearly Bonus

Healthcare Benefits

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