Director, QA Operations
2 months ago
Our clinical stage vaccine client here in Boston, MA is growing and looking to add a
Director, QA Operations
(REMOTE) to their team This role will be responsible for oversight of GMP activities and disposition of clinical supplies. They will be responsible for working in partnership with Technical Operations, and GMP suppliers to assure compliance with quality standards and global regulatory authority expectations. Director will act as key Quality partner with other company functional areas, third parties and partners; and provide direct QA oversight and support for external manufacturing, quality control and product development. Will also perform/oversee disposition of clinical trial material; and provide QA input to technology transfer plans, specifications, procedures, processes, and product development plans. Responsibilities include but not limited to:
Assure that all processes contributing to the clinical supply are conducted in 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.
Support supplier quality management activities, including audits, quality agreement review, and performance management activities
Provide quality support to Technical Operations and QC functional areas.
Actively represent Quality input at cross-functional team meetings.
Responsible for implementing and managing Quality Assurance processes and strategy
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).
Authoring of procedures and training materials.
Responsible for providing Quality operational support for key quality systems (e.g. complaints, document management, training and change control)
Manages contract support that may be required to support execution of QA responsibilities.
Develop and oversee appropriate area specific Quality metrics and reporting on the state of GMP compliance
Review and communicate current & emerging regulatory requirements (US and international regulations and guidelines).
Requirements:
Minimum of a bachelor’s degree in biological sciences; advanced degree in biological sciences desirable
A minimum of 8 years’ experience in a pharmaceutical/biologics company with at least two (2) in a leadership role
Experience with biologics/vaccines is required
Strong understanding of GMP Quality for pre-clinical, clinical, and commercial stage work.
Demonstrated ability to interpret and apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU GMP regulations
Expertise in batch disposition, root cause investigations, change control, commercial manufacturing oversight and regulatory inspections
Other:
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
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