Overview: The Quality Assurance Officer II provides guidance and coordination in the development, implementation and maintenance of Quality Assurance systems and activities at Replimune. Manage batch review to ensure timely release of drug product for clinical and commercial use. Ensures relevant quality and regulatory requirements are met for manufacturing and testing and ensures site compliance with quality system regulations issued by FDA, MHRA and other applicable regulatory bodies. Responsible for the evaluation and assurance that appropriate quality systems are in place at approved vendors and suppliers supporting GXP.
This position is based in our
Milton Park
location and typically has a 5-day on-site expectation. Responsibilities:
Key responsibilities:
Manage the batch review program to ensure timely release of drug product, which includes Qualified Person release of products for the EU. Maintain and manage the internal and external audit program. Lead and direct audits of GMP materials and service providers. Manage QA review of change controls and deviations pertaining to Operations. Assist in the establishment, implementation and maintenance of Quality Management Systems (QMS) in accordance with applicable standards established by FDA, MHRA, and other regulatory bodies. Interface with internal customers in Product Development, Quality Control Labs, etc., and, as appropriate, with external vendors to support ongoing compliance with Replimune requirements and quality standards. Oversees or facilitates Replimune’s QA interactions with external vendors such as Contract Manufacturing Organizations, and other service providers to ensure compliance with Replimune requirements and GXP quality standards. Support the oversight of Replimune compliance and Quality systems: audits, vendor qualification, change control, deviation and investigation management, corrective and preventive action systems, QC release testing. Other responsibilities:
Support Replimune Clinical QA activities. Draft, review, provide oversight to content, and approve controlled documents which may include but are not limited to standard operating procedures, validation documents, material specifications, etc. Other duties, as assigned. Qualifications:
Educational requirements:
B.A or B.S. degree in an appropriate scientific/technical field.
Experience and skill requirements:
>6 years’ experience in relevant Quality Systems, technology and/or supervision in a regulated biotechnology or pharmaceutical industry environment. GXP experience, including auditing. Knowledge of FDA and MHRA guidelines regarding GMPs. Excellent verbal and written communication skills. Location: This position is based in our
Milton Park
location and typically has a 5-day on-site expectation.
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Milton Park
location and typically has a 5-day on-site expectation. Responsibilities:
Key responsibilities:
Manage the batch review program to ensure timely release of drug product, which includes Qualified Person release of products for the EU. Maintain and manage the internal and external audit program. Lead and direct audits of GMP materials and service providers. Manage QA review of change controls and deviations pertaining to Operations. Assist in the establishment, implementation and maintenance of Quality Management Systems (QMS) in accordance with applicable standards established by FDA, MHRA, and other regulatory bodies. Interface with internal customers in Product Development, Quality Control Labs, etc., and, as appropriate, with external vendors to support ongoing compliance with Replimune requirements and quality standards. Oversees or facilitates Replimune’s QA interactions with external vendors such as Contract Manufacturing Organizations, and other service providers to ensure compliance with Replimune requirements and GXP quality standards. Support the oversight of Replimune compliance and Quality systems: audits, vendor qualification, change control, deviation and investigation management, corrective and preventive action systems, QC release testing. Other responsibilities:
Support Replimune Clinical QA activities. Draft, review, provide oversight to content, and approve controlled documents which may include but are not limited to standard operating procedures, validation documents, material specifications, etc. Other duties, as assigned. Qualifications:
Educational requirements:
B.A or B.S. degree in an appropriate scientific/technical field.
Experience and skill requirements:
>6 years’ experience in relevant Quality Systems, technology and/or supervision in a regulated biotechnology or pharmaceutical industry environment. GXP experience, including auditing. Knowledge of FDA and MHRA guidelines regarding GMPs. Excellent verbal and written communication skills. Location: This position is based in our
Milton Park
location and typically has a 5-day on-site expectation.
#J-18808-Ljbffr
