Senior QC Microbiology Director

GlaxoSmithKline; Upper Merion Township (Montgomery County); On-site; USD 130,000 - 170,000; Full time

Job summary

GlaxoSmithKline in Upper Merion, PA is seeking a Quality Control Microbiology Manager to plan and prioritize resource allocation in the QC Microbiology laboratory to meet testing requirements for product release, raw materials, utilities, and in-process testing.

Lead assay transfers, qualification, and validation for QC use; ensure cGMP compliance and timely release of results; prepare IND, BLA, and MAA filings to support regulatory submissions and manufacturing.

Qualifications

• Bachelor's degree in microbiology or a related field with 7+ years' industry experience.
• 7+ years in a GxP or FDA-regulated environment is required.
• 7+ years in biopharma and supervisory or leadership roles preferred.
• Master’s degree is a plus.

Responsibilities

• Lead resource planning and training for QC microbiology analysts.
• Oversee transfer, qualification, and validation of new assays for QC use.
• Ensure cGMP compliance and timely release of test results.
• Prepare regulatory documents (IND, BLA, MAA) for filings.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Problem Solving

Quality Assurance

Quality Control

Risk Awareness

Testing Operations

Education

Bachelor's degree in Microbiology or related field

Master’s degree

Job description

GlaxoSmithKline in Upper Merion, PA is seeking a Quality Control Microbiology Manager to plan and prioritize resource allocation in the QC Microbiology laboratory to meet testing requirements for product release, raw materials, utilities, and in-process testing.

Lead assay transfers, qualification, and validation for QC use; ensure cGMP compliance and timely release of results; prepare IND, BLA, and MAA filings to support regulatory submissions and manufacturing.