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Role Summary
QC Laboratory Manager – lead a team to ensure the highest quality standards in laboratory operations, overseeing activities to ensure regulatory compliance and good manufacturing practices. Drive continuous improvement, develop the team, and collaborate across departments to deliver impactful results.
Responsibilities
- Develop and implement strategies to ensure laboratory compliance with regulatory standards and company policies.
- Lead and mentor a team of laboratory professionals, fostering their growth and development.
- Manage laboratory operations, including resource allocation, budgets, and equipment maintenance.
- Oversee audits and inspections, ensuring adherence to safety and quality standards.
- Drive continuous improvement initiatives to enhance efficiency, quality, and cost-effectiveness.
- Collaborate with cross-functional teams to support production and new product introductions.
Qualifications
- Required: Bachelor’s degree in a scientific field such as chemistry, biochemistry, or related discipline.
- Required: 5+ years of experience in a GMP-regulated laboratory environment.
- Required: 5+ years of experience supervising or managing a team.
- Required: Experience with laboratory audits and inspections.
- Preferred: Master’s degree in a scientific field.
- Preferred: Strong leadership and interpersonal skills.
- Preferred: Experience in analytical method validation and transfer processes.
- Preferred: Ability to prioritize and manage multiple tasks effectively.
- Preferred: Excellent verbal and written communication skills.
- Preferred: Familiarity with continuous improvement methodologies and tools.
- Preferred: Proven experience in a quality support role within the pharmaceutical or biopharmaceutical industry.
- Preferred: Strong knowledge of laboratory compliance and regulatory requirements.
Skills
- Laboratory management
- Regulatory compliance (GMP)
- Audits and inspections
- Continuous improvement
- Team leadership and development
- Cross-functional collaboration
- Analytical method validation and transfer
- Effective communication
Education
- Bachelor’s degree in chemistry, biochemistry, or related discipline
- Master’s degree (preferred)
Additional Requirements
- On-site role based in the United States.