Director, Quality Control

Role Summary

Director of Quality Control provides comprehensive administrative and technical direction across diverse QC functions, including Virology, Microbiology, and Immunochemistry. This pivotal role ensures timely and compliant support for all testing phases, setting departmental strategy and driving continuous improvement while adhering to internal specifications and regulatory requirements like USDA and cGMP/GLP. The Director champions strategic initiatives, manages significant budgets, and fosters cross-site collaboration within the Elanco network. Location: Winslow, Maine (On-Site).

Responsibilities

• Strategic Leadership: Lead and direct the Quality Control department, establishing strategic objectives, managing significant budgets, and developing a high-performing team to ensure efficient operations and data integrity.
• Regulatory Compliance: Ensure robust compliance with 9 CFR, USDA, cGMP/GLP, and Elanco Global Quality Standards across all QC operations, including documentation, change management, and laboratory investigations.
• Operational Oversight: Oversee all aspects of quality control testing, from raw materials to product release, ensuring timely data generation, thorough out-of-specification (OOS) investigations, and proactive risk mitigation.
• Continuous Improvement: Drive innovation and continuous improvement initiatives within QC, sharing best practices across the Elanco network and ensuring the validated state of test methods and laboratory systems.
• Technical Expertise: Offer expert technical guidance, troubleshooting, and scientific support to the team, developing and updating SOPs, and improving laboratory techniques and procedures.

Qualifications

• Required: Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or an advanced degree.
• Required: 6 years of experience in a regulated pharmaceutical/vaccine manufacturing environment, with significant experience in Quality Control laboratory operations and personnel management.
• Required: Proven experience in department oversight, including organizational, budgeting, and strategic planning. Demonstrated ability to lead teams to achieve results and actively engage in the leadership and professional development of team members.
• Preferred: Significant working and theoretical knowledge to objectively assess procedures, apply appropriate risk assessment, and recommend improvements. Thorough and technically correct decision-making skills.
• Preferred: Advanced oral and written communication skills, with the ability to work and communicate effectively with diverse groups across the organization at all levels, both locally and globally.
• Preferred: Ability to use technical knowledge to solve complex problems, recognize and react to the significance of data/results, and lead investigations.
• Preferred: Proficiency in lean/5S/six sigma methodologies.

Education

• Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or an advanced degree.