Director, Quality Control
Elanco
3 months ago
On-site
Winslow, ME
Operations
Your Role: Director, Quality Control
Responsibilities:
- Strategic Leadership: Lead and direct the Quality Control department; establish strategic objectives; manage budgets; develop a high-performing team to ensure efficient operations and data integrity.
- Regulatory Compliance: Ensure compliance with 9 CFR, USDA, cGMP/GLP, and Elanco Global Quality Standards across QC operations, including documentation, change management, and laboratory investigations.
- Operational Oversight: Oversee all 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 QC innovation and continuous improvement; share best practices across the Elanco network; ensure validated test methods and laboratory systems.
- Technical Expertise: Provide technical guidance, troubleshooting, and scientific support; develop and update SOPs; improve laboratory techniques and procedures.
What You Need to Succeed (minimum qualifications):
- Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or an advanced degree.
- 6 years of experience in a regulated pharmaceutical/vaccine manufacturing environment with significant QC laboratory operations and personnel management experience.
- Proven department oversight experience (organizational, budgeting, strategic planning); demonstrated ability to lead teams and support leadership/professional development.
What Will Give You the Competitive Edge (preferred qualifications):
- Knowledge to assess procedures, apply risk assessment, and recommend improvements; technically correct decision-making.
- Advanced oral and written communication skills; ability to work with diverse groups locally and globally.
- Ability to solve complex problems, interpret data/significance, and lead investigations.
- Proficiency in lean/5S/six sigma methodologies.
Benefits (highlights):
- Multiple relocation packages; two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO); 8-week parental leave; 9 Employee Resource Groups; annual bonus offering; flexible work arrangements; up to 6% 401K matching.
Location: Winslow, Maine (on-site).
Responsibilities:
- Strategic Leadership: Lead and direct the Quality Control department; establish strategic objectives; manage budgets; develop a high-performing team to ensure efficient operations and data integrity.
- Regulatory Compliance: Ensure compliance with 9 CFR, USDA, cGMP/GLP, and Elanco Global Quality Standards across QC operations, including documentation, change management, and laboratory investigations.
- Operational Oversight: Oversee all 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 QC innovation and continuous improvement; share best practices across the Elanco network; ensure validated test methods and laboratory systems.
- Technical Expertise: Provide technical guidance, troubleshooting, and scientific support; develop and update SOPs; improve laboratory techniques and procedures.
What You Need to Succeed (minimum qualifications):
- Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or an advanced degree.
- 6 years of experience in a regulated pharmaceutical/vaccine manufacturing environment with significant QC laboratory operations and personnel management experience.
- Proven department oversight experience (organizational, budgeting, strategic planning); demonstrated ability to lead teams and support leadership/professional development.
What Will Give You the Competitive Edge (preferred qualifications):
- Knowledge to assess procedures, apply risk assessment, and recommend improvements; technically correct decision-making.
- Advanced oral and written communication skills; ability to work with diverse groups locally and globally.
- Ability to solve complex problems, interpret data/significance, and lead investigations.
- Proficiency in lean/5S/six sigma methodologies.
Benefits (highlights):
- Multiple relocation packages; two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO); 8-week parental leave; 9 Employee Resource Groups; annual bonus offering; flexible work arrangements; up to 6% 401K matching.
Location: Winslow, Maine (on-site).