New · posted Oct 15
Exela Pharma · Pharmaceuticals
Manager, QC Microbiology
- Lenoir, NC
- On-site
- Full-time
- Manager
Open until filled
The role
The QC Microbiology Manager will report directly to quality upper management, (i.e., Director of QC) and will provide both strategic and tactical leadership as part of the QC group. The incumbent will participate in strategic and technical planning for the quality control group, and will be responsible for establishing testing timelines, executing the plan and monitoring the results. The incumbent will be responsible for building, leading and developing a group of quality control microbiologists that support the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration. The individual will be responsible for implementing policies and procedures that improve safety and productivity.
What you need
Education Requirements
- Master’s Degree/Bachelor’s degree in Microbiology or related scientific discipline with approximately 5 years industry in QC -
What you'll do
- Write and Implement Standard Operating Procedures according to cGMP and cGLP.
- Develop and validate new test methods for raw material, in-process, and finished product samples (Sterility, Bioburden and Indicator Organisms, Endotoxin, AET, etc. per USP and FDA guidance)
- Establish and implement Environmental Monitoring Program (air, compressed gases, water, surfaces, personnel) per USP, FDA, ISO, and PDA guidelines.
- Performance and documentation of laboratory investigations
- Develop and perform Disinfectant Effectiveness Studies
- Develop and implement cleaning and sterile gowning procedures with the Operations Department
- Internal auditing and handling of external audits by customers and FDA during departmental review
- Develop and maintain cryo-stored cell line including in house identified isolates
- Purchase equipment and materials
- Hire and train staff
- Assist with autoclave and depyrogentaion oven validations
- Manage design and performance of Media Fills with input from Quality Assurance, Validations, and Operations
- This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA) training within 1 year of hire, and annually thereafter.
Where you'll work
Lenoir, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Lenoir, NCJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Manager roles in the US24 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $108,500 | $127,250 | $143,500 |
Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 275 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Exela Pharma's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 15 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods4
- Documentation and SOPs4
- GMP and compliance3
- Validation and qualification3
- Collaboration and leadership3
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Exela Pharma on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Quality3 100%
By level
- Manager2 67%
- Director1 33%
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Manager, QC Microbiology at Exela Pharma
Open until filled.