Elanco Animal Health

Manager - Hub QA

Elanco Animal Health$88K — $105K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in biology, chemistry, or a related science field.
  • 5+ years of experience in regulated pharmaceutical/vaccine manufacturing with quality oversight.
  • Strong knowledge of cGMP/GLP and USDA/FDA regulations.
  • Proven leadership in developing technical teams and making risk-based quality decisions.
  • Effective cross-function communication skills at various organizational levels.

Responsibilities

  • Lead the Hub Quality team and ensure effective execution of the Quality Management System.
  • Oversee quality systems, including deviations, investigations, and change controls.
  • Ensure quality oversight for incoming materials and finished goods.
  • Manage the site Supplier Quality program focusing on approvals and audits.
  • Collaborate with various departments to mitigate compliance risks and enhance quality processes.

Benefits

  • Comprehensive health and wellness programs.
  • Opportunities for professional development and continuing education.
  • Flexible work arrangements to support work-life balance.
  • Employee assistance programs including mental health support.
  • Engagement activities and community involvement initiatives.
Full Job Description
Your Role: Manager, Hub Quality As the Manager, Hub Quality, you will provide quality leadership and technical oversight for the Fort Dodge Hub Warehouse, supporting incoming inspection, material storage and handling, packaging and labeling operations, and supplier quality. In this role, you will lead the Hub Quality team, ensure compliance with regulatory and Elanco quality requirements, and drive continuous improvement across quality systems and warehouse operations. Your Responsibilities: • Provide leadership, technical guidance, training, and development for the Hub Quality team while ensuring effective execution of the Quality Management System and continued inspection readiness. • Oversee quality systems including deviations, investigations, CAPA, complaints, change controls, SOPs, and escalation of significant quality and compliance issues. • Lead quality oversight for incoming materials, raw material sampling and release, material storage and control, packaging and labeling operations, and finished goods batch release. • Own the site Supplier Quality program, including supplier approvals, risk assessments, quality agreements, audit planning and responses, supplier CAPAs, and change notifications. • Partner cross-functionally with Operations, Engineering, Regulatory, Procurement, R&D, Affiliate Quality, and Global Quality teams to manage compliance risks, support audits and inspections, and drive quality and process improvement initiatives. What You Need to Succeed (minimum qualifications): • Education: Bachelor's degree in biology, Chemistry, or another science-related field. • Experience: Minimum of 5 years of experience in regulated pharmaceutical and/or vaccine manufacturing, including experience with quality oversight and leadership of technical teams. • Skills: Strong knowledge of cGMP/GLP and USDA/FDA regulatory requirements; demonstrated ability to lead and develop technical teams, make risk-based quality decisions, and communicate effectively across functions and organizational levels. What Will Give You a Competitive Edge (preferred qualifications): • Experience with warehouse quality operations, incoming material inspection and release, packaging and labeling, and finished goods batch release. • Experience managing supplier quality programs, including supplier qualification, audits, risk assessments, quality agreements, and CAPA. • Experience leading investigations, deviations, CAPA, change controls, and regulatory or corporate audit responses. • Knowledge of SAP quality data, quality systems, statistics, databases, and risk-management principles. • Demonstrated success leading cross-functional quality initiatives and continuous improvement projects within a regulated manufacturing environment.

About Elanco Animal Health

Elanco Animal Health is an American pharmaceutical company that develops and produces products for animal health. The company was founded in 1954 and is headquartered in Greenfield, Indiana. Elanco produces a wide range of products for both livestock and pets, including vaccines, antibiotics, and parasiticides. The company operates in more than 90 countries and has a global workforce of over 5,500 employees. Elanco was spun off from Eli Lilly and Company in 2018 and became a publicly traded company in September of that year. The company is listed on the New York Stock Exchange under the ticker symbol ELAN.
Learn more about Elanco Animal Health
Size
9,000 employees
Market Cap
$5.3 billion
Industry
Net Income
-$560 million
5 Year Trend
+10.3%
Revenue
$3.2 billion
NASDAQ

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