Quality Control Director — cGMP & Compliance

Fraser Dove International

Maryland

On-site

USD 180,000 - 240,000

Full time

10 days ago

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Job summary

Fraser Dove International is partnering with an established biopharmaceutical organisation in Maryland to direct Quality Control laboratory operations. The Director will lead laboratory leaders and analysts, ensure compliant sampling, testing, data integrity and release activities in alignment with ALCOA and regulatory requirements.

You will drive scientific excellence, oversee investigations, support IND/BLA/MAA submissions, and develop the QC team and processes.

Qualifications

10+ years of biopharma experience in analytical/biochemistry or microbiology.
8+ years of supervisory/managerial experience across technical teams.
Strong written and verbal communication with cross-functional partners.
Bachelor's degree in a science.
Extensive GMP, NIH, ICH, FDA regulatory knowledge.

Responsibilities

Lead and empower laboratory leaders and analysts to support compliant sampling, testing, data generation and review.
Provide in-depth technical guidance to laboratory supervisors, analysts and Operations.
Ensure investigations are completed timely with accurate records and documented data.
Develop the QC team technically and professionally, raising proficiency and scientific excellence.
Ensure compliance with SOPs and safety procedures governing analytical QC testing.
Support regulatory filings (IND, BLA, MAA) submissions.
Oversee testing and release activities, sample management, stability and monitoring.