How You Will Make an ImpactLeader Functions (Responsibilities):
- Lead the Quality Control (QC) and Microbiology laboratories, ensuring alignment with organizational objectives, timelines, and strategic goals.
- Recruit, hire, and manage the Quality Control team, fostering a culture of accountability, engagement, and continuous improvement.
- Ensure compliance with global Good Manufacturing Practice (GMP) regulations and maintain inspection readiness across all laboratory operations.
- Collaborate with cross-functional teams and external clients to ensure QC testing aligns with project timelines and regulatory expectations in a CDMO environment.
- Evaluate staff training effectiveness, maintain training compliance, and foster a culture of continuous improvement and scientific excellence.
Essential Functions (Responsibilities):
- Manage stability testing and protocols, ensuring timely execution and thorough assessment of data to identify and document adverse trends.
- Define and implement continuous improvement initiatives within Quality Control (QC) and Microbiology laboratories to enhance operational efficiency and data quality.
- Maintain laboratory equipment, supplies, and controlled environments; oversee inventory and purchasing to support uninterrupted operations within budget constraints.
- Apply technical expertise in analytical instrumentation and testing methods (e.g., High-Performance Liquid Chromatography (HPLC), weighing equipment, environmental chambers) to support troubleshooting and ensure data integrity.
- Utilize a thorough understanding of United States Food and Drug Administration (FDA), International Council for Harmonization (ICH), and European regulatory guidelines to ensure compliance in analytical testing and documentation practices.
- Communicate project goals, technical results, and operational updates clearly to team members and cross-functional stakeholders to support collaboration and transparency.
- Professional Conduct and Workplace Culture: Ensure full-time attendance, exhibit professionalism with business associates, and align daily actions with organizational values.
What You Will Bring to the Role- Minimum Required: Bachelors science related or chemistry
- Preferred: MS or PhD in relevant scientific discipline
- Minimum Required: 8+ in Quality Control role in an FDA-regulated pharmaceutical environment
- Required People Management: 4+ years
- Preferred: Background in Contract Development and Manufacturing Organization (CDMO)
