Manager, Quality Systems & Compliance

MSD • Elkhorn, NE

1d • Hybrid

About The Position

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. At our company's Animal Health division, we are dedicated to advancing the prevention and treatment of diseases in animals through innovative health solutions. We are seeking a highly skilled and motivated Quality Assurance Manager to join our team. This role is crucial in ensuring the highest standards of quality and compliance in our manufacturing processes. If you are passionate about quality assurance and have a strong background in quality systems, risk assessments and compliance we invite you to apply and contribute to our mission of saving and improving lives around the world. Our Quality Assurance team ensures every single material inside of our products is manufactured, processed, tested, packaged, stored and distributed aligned with our high standards of quality and meets all regulatory requirements. We are seeking a growth and improvement minded individual to join our Quality Assurance (QA) team as the Manager, Quality Systems & Compliance that can help drive our Strategic Priorities. This role will manage between 6-9 direct reports and will report to the Associate Director of Quality Assurance.

Requirements

• Bachelor's degree (science or engineering degree preferred)
• Five (5) years in a Quality or Manufacturing role in a government regulated industry
• Able to work independently and as a team member with integrity, precision, and respect
• Principled verbal and written communication
• Lead and work within a team
• Consistent decision-making abilities
• Root Cause Analysis and Troubleshooting skills
• Technical writing skills
• Accountability
• Applied Engineering
• Audits Compliance
• Compliance Reviews
• Consulting
• Corrective Action Management
• Driving Continuous Improvement
• IS Audit
• Manufacturing Processes
• Manufacturing Support
• Production Supervision
• Professional Integrity
• Quality Assurance (QA)
• Quality Control Management
• Quality Improvement Programs
• Quality Management
• Quality Management Systems (QMS)
• Quality Process Development
• Quality Standards
• Regulatory Compliance Consulting
• Reporting and Analysis
• Risk Management
• Root Cause Analysis (RCA)
• Supplier Quality Management

Nice To Haves

• Working knowledge of good aseptic techniques
• Knowledge and familiarity with the 9 CFR and the USDA
• Experience in Lean, Six-Sigma or Operational Excellence

Responsibilities

• Leadership, feedback, and coaching to QA colleagues through routine performance evaluations and responsibility oversight activities
• Compliance oversight and guidance for Manufacturing Integrated Processing Teams (IPT's), Engineering/Maintenance and other production adjacent departments
• Actively contribute to manufacturing teams by providing guidance and oversight in relation to the 9 CFR and company Quality Standards
• Participate in manufacturing walks and internal/external audits
• Oversee disposition of raw materials, in-process antigens and finished vaccines
• Quality System oversight including Deviations, CAPAs, and Change Controls
• Drives continuous improvement of all quality systems and compliance activities
• Assist with or communicate directly through verbal and/or in writing with regulatory authorities
• Participate in and provide direct guidance during external audits and inspections
• Help manage and maintain adherence to the QA budget
• Communicate product quality problems and provides metrics for Tier meetings, Site Quality Council, and Extended Leadership Team meetings

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager