Quality Assurance Team Lead

As a Quality Assurance Team Lead, you will spearhead our on-site quality initiatives, ensuring that all production processes adhere to rigorous cGMP standards. You will play a pivotal role in maintaining compliance, driving continuous improvement, and overseeing the release of high-quality pharmaceutical products to the global market.

About the Role
As a Quality Assurance Team Lead, you will spearhead our on-site quality initiatives, ensuring that all production processes adhere to rigorous cGMP standards. You will play a pivotal role in maintaining compliance, driving continuous improvement, and overseeing the release of high-quality pharmaceutical products to the global market.

Responsibilities

Lead and mentor the on-site QA team, managing daily workflows, training, and performance evaluations to ensure operational excellence.

Oversee the inspection and release of raw materials, intermediate products, and finished goods based on established specifications.

Manage the lifecycle of quality documentation, including batch record reviews, deviations, investigations, change controls, and CAPAs.

Drive the development and maintenance of robust Quality Management Systems (eQMS) to ensure alignment with FDA, ICH, and industry regulatory requirements.

Collaborate with cross-functional teams to identify facility events, ensuring accurate documentation and timely resolution.

Compile and present key quality metrics to leadership to support data-driven decision-making and process improvements.

Participate in internal and external audits, proactively addressing findings to uphold the highest standards of quality compliance.

Required Skills

Associate degree in a relevant field.

5+ years of experience in a regulated pharmaceutical or biopharmaceutical quality environment.

Demonstrated proficiency in cGMP, batch record review, and quality management systems.

Strong leadership capabilities with experience in workload management and team coordination.

Preferred Skills

Bachelor's degree in a scientific or related discipline.

10+ years of progressive experience in quality assurance roles.

Advanced knowledge of MasterControl or similar eQMS platforms.

Proven track record in regulatory audit participation and CAPA management.

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