Quality Control Microbiology Associate 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

The Quality Control Microbiology Manager is responsible for planning and prioritizing resource allocation in Upper Merion Biopharma quality control microbiology laboratory to meet testing requirements for product release, raw material, utility, in-process, etc. Oversee the operation of QC Microbiology area which includes bioburden, endotoxin, and other microbiology testing areas. Responsible for managing training of quality control analysts, transferring assays from the development group, qualifying, and validating new assays and implementing assays to be used for quality control purposes to support manufacturing and marketing of the product. Other functions: conduct laboratory investigations related to product testing, compile reports in support of product filings with the regulatory agencies. Review and release of test results and ensure full cGMP compliance in the laboratory operations. Prepare documents (IND, BLA and MAA) to support regulatory filing.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Responsible for managing training of quality control microbiologist and specialists, transferring assays from development group, qualify and validate new assays and implement assays to be used for quality control purposes to support manufacturing and commercial products. Work directly with other QC groups to ensure timelines are met for release, technical transfers, stability and in-process testing. Conduct laboratory investigations related to product testing. Compile reports in support of product filings with the regulatory agency. Review and release of test results. Ensure group compliance with laws, regulations, guidelines, procedures, and practices governing microbiological QC testing, including departmental and corporate standard operating procedures and safety procedures. Ensure technical and professional growth of QC analysts, encouraging excellence and continuous improvement in their performance. Collaborate and work effectively within the Quality Control groups as well as other departments. Represent the quality control department and departmental functions on company projects/committees. Review, update regulatory documents (IND, EOP2, IMPD), as required.

Why you?

• Bachelors degree 7+ years of experience in microbiology 5+ years of experience of supervisory or leadership skills 7+ years of GxP or FDA regulated environment 7+ years of experience of biopharma

• Master’s degree
• Strong interpersonal and leadership skills.
• Solid team player able to function within team based organization.
• Strong verbal and written communication skills.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA.
• Able to prioritize and decide appropriate course of actions.
• Effective at implementing decisions.
• Fully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of microbiological quality functions.

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Problem Solving
• Quality Assurance (QA)
• Quality Control (QC)
• Risk Awareness
• Testing Operations

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail]

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.