Manager / Sr. Manager, QA Operations (Remote)

Our clinical stage vaccine company here in Boston, MA is growing and looking to add a Manager/Senior Manager of Quality Assurance (operations/REMOTE) to their team! This role will provide oversight of GMP activities and the supports disposition of clinical supplies. They will work in partnership with Technical Operations, and GMP suppliers to assure compliance with quality standards and global regulatory authority expectations. Will also identifying/mitigating product quality and regulatory compliance risks, as well as working to establish Quality Operations processes and controls in compliance with applicable global regulations. Mgr/Sr. Mgr will act as key Quality partner with other company functional areas, third parties and partners and provide direct QA oversight and support for the assigned area (e.g. external manufacturing, quality control and product development).

Responsibilities include but not limited to:

• Ensures all processes contributing to the clinical supply, are conducted in a compliance with applicable regulations and requirements.

• Responsible for compliant, thorough, and accurate batch review / batch disposition.

• Review and approve SOPs, specifications, and other CDMO controlled documents.

• Supports the development and maintenance of quality systems supporting GxP operations.

• Provide quality support to Technical Operations and/or QC functional areas.

• Executes Quality Assurance processes effectively.

• Provide Quality oversight of CMOs and GMP service providers including, approval of suppliers, auditing, quality agreements and monitoring of performance.

• Provides Quality oversight or ownership Quality records (e.g. Investigations, CAPA, Change Controls, SOPs, Quality Plans, Risk Assessments).

• Authors procedures and training materials.

• Reports appropriate Quality metrics and monitors the state of GMP compliance.

Requirements:

• Minimum of a bachelor's degree in biological sciences; advanced degree in biological sciences desirable

• A minimum of 6 years' experience in a pharmaceutical/biologics company with at least two (2) in third party manufacturing QA preferred

• Experience with biologics/vaccines is required.

• Strong understanding of GMP Quality for pre-clinical, clinical, and commercial stage work.

• Demonstrated ability to apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU GMP regulations.

• Highly skilled in batch disposition, root cause investigations, change control, commercial manufacturing oversight and regulatory inspections.

Travel Requirements:

• Location Remote-US East Coast preferred.

• Willingness to travel (20-25%) to various meetings or third-party sites, including overnight trips.

• Some international travel may be required.