Senior QC Microbiology Lead — Validation & Compliance

Bora Pharmaceuticals; Rockville (MD); On-site; USD 127,000 - 160,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Paid time off

Wellness programs

Job summary

Bora Biologics is seeking a Sr. Manager of Quality Control - Microbiology in Rockville, MD, to lead a team responsible for environmental monitoring, microbial testing, and method validation in a multi-product CDMO.

The role ensures ALCOA+ data integrity and regulatory readiness across audits and client inquiries. The successful candidate will drive continuous improvement, manage CAPA and investigations, and collaborate across QC, QA, Validation, Manufacturing, and Clients to meet batch release

Qualifications

• Bachelor's Degree in a scientific discipline with at least 7 years of QC Microbiology cleanroom experience.
• At least 2 years of prior staff supervision experience.
• Experience with GMP testing and microbial method validation including drafting protocols and reports.
• Familiarity with EU GMP Annex 1 and ALCOA+ data integrity requirements.
• Experience conducting environmental excursion investigations.
• Experience with microbial identification.
• Ability to work independently and manage multiple priorities in a fast-paced setting.
• Strong written and verbal communication; conflict resolution capabilities.
• CDMO or multi-client/campaign cGMP environment experience.
• Proficiency with SAP, LIMS, Veeva, and statistical trending tools.

Responsibilities

• Lead the QC Microbiology team and prioritize lab scheduling and workflow.
• Supervise environmental monitoring of clean rooms and GMP facilities per ISO/EU standards.
• Contribute to Contamination Control Strategy and risk assessments.
• Review trends and recommend changes to senior management.
• Ensure GMP systems and data integrity across records and LIMS entries.
• Lead investigations for OOS results and deviations in micro procedures.
• Drive CAPA, Change Control, Deviation, Risk Management and investigations.
• Develop and validate microbial test methods and transfer to operations.
• Mentor staff and ensure proper protocol development and reporting.
• Collaborate with QC Analytical, QA, Validation, Manufacturing, Facilities, and Clients.

Skills

QC Microbiology

Team supervision

Regulatory compliance

cGMP knowledge

ALCOA+ data integrity

Environmental monitoring

Risk assessment

Method validation

Technical leadership

Independent judgment

Education

Bachelor's Degree in a scientific discipline

7+ years QC Microbiology experience

Tools

SAP

LIMS

Veeva

Statistical tools

Job description

Bora Biologics is seeking a Sr. Manager of Quality Control - Microbiology in Rockville, MD, to lead a team responsible for environmental monitoring, microbial testing, and method validation in a multi-product CDMO.

The role ensures ALCOA+ data integrity and regulatory readiness across audits and client inquiries. The successful candidate will drive continuous improvement, manage CAPA and investigations, and collaborate across QC, QA, Validation, Manufacturing, and Clients to meet batch release