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Job Description
The Associate Manager QA is responsible for all aspects of the QA Team; provides leadership and support to direct reports and will provide QA oversight for Manufacturing Operations to ensure that drug substance manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
A typical day might include, but is not limited to, the following:- Leading all aspects of the QA Team including review and approval of the following types of documents, relating to area functions: Master records / executed records / failure investigations / CC / SOPs / validation protocols and summary reports / incursions.
- Approving various documents relating to area function, including those listed above.
- Coordinating QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management.
- Performing compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.
- Reviewing customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality.
- Participating in regulatory and customer audits.
This role might be for you if:
- You are a dedicated leader who can train, mentor and lead employees across shift teams.
- Previous experience as QA SME in a highly regulated environment (e.g. pharma or biotech in both internal and external regulatory audits).
- You have the ability to maintain integrity and honesty at all times.
- You are an expert in GMP & GDP knowledge.
To be considered for this opportunity you should have a BS/BA in life sciences discipline or related field with a minimum of 7 years of experience in a pharmaceutical or biologics manufacturing environment.
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