Senior Pharma Lab Director - Ops, Quality & Compliance

Eagle Analytical

Phenix City (AL)

On-site

USD 110,000 - 170,000

Full time

4 days ago

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Job summary

Eagle Analytical seeks a Lab Manager to oversee daily operations and drive strategic lab initiatives, ensuring timely turnaround and top-tier data quality. You will lead KPI development, QA, audits, and continuous improvement while mentoring staff and coordinating with clients and regulatory bodies.

This role requires a strong background in pharmaceutical analytics and a proven track record in regulated labs; travel up to 10% may be required.

Qualifications

Bachelors in Chemistry or related field required; advanced degree preferred.
Seven years of progressive leadership in pharma or regulated labs.
Strong knowledge of cGMP, cGLP, ISO 17025 and regulatory expectations.
Experience with deviation management, OOS investigations and CAPAs.
Proficient with laboratory information systems (LIMS).

Responsibilities

Provide executive leadership for day-to-day and long-term lab operations.
Establish and monitor KPIs for turnaround time, throughput, data quality and efficiency.
Ensure labs are scalable, compliant, and meet pharma testing demands.
Lead continuous improvement to optimize workflows and resources.
Serve as SME in pharmaceutical analytical chemistry, including method development and validation.
Ensure data quality meets regulatory standards and audits.
Oversee QA activities and CAPA implementation.
Mentor lab leadership and staff; align staffing with regulatory requirements.
Partner with IT to optimize LIMS and analytical systems.
Support client-facing discussions and regulatory audits.
Travel up to 10% to customer or partner locations as required.