Hybrid Associate Director, Compliance

at MSD

• Job title: Associate Director, Compliance
• Job type: Full Time
• Experience level: Senior
• Salary: $139,600 - $219,700 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Millsboro, United States

About the role

• Associate Director of Compliance responsible for ensuring compliance with USDA regulations in animal health manufacturing. Collaborating with various stakeholders across manufacturing sites and maintaining quality management systems.

Responsibilities

• Provide Subject Matter Expertise to ensure our company’s manufacturing sites adhere to compliance standards established in 9CFR and enforced by USDA-APHIS-CVB Inspection and Compliance (IC), and Policy, Licensing and Evaluation (PEL).
• Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements for facility design, auditing, quality systems and ensure team and company adherence to these documents.
• Develop a risk-based approach to prioritize USDA compliance requirements for our manufacturing sites.
• Ensure any audits or sites assessments are conducted to assess compliance with applicable USDA regulations/ guidelines, customer requirements, SOPs and project specific guidelines/ instructions.
• Evaluate audit findings and ensure timely identification/ escalation of potential critical observations and compliance gaps observed during audits.
• Develop and maintain a strong training program for USDA requirements to increase knowledge and skills development and ability to detect and communicate GxP compliance concerns.
• Maintain up-to-date knowledge base with respect to emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements.
• Participate in industry groups (e.g. Animal Health Institute) that assess and influence standards and trends within Animal Health.
• Provide updates to company stakeholders on GxP and regulatory trends as well as the auditing program’s ability to detect compliance to current and evolving expectations.
• Ensure timely identification and escalation of potential critical observations and compliance gaps
• Lead high-risk or complex audits.
• Oversee quality and compliance activities within assigned area of focus.
• Comply with all of our company's corporate guidelines and policies.

Requirements

• B.S. in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required and 8 years of experience OR
• M.S. in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required and 5 years of experience OR
• Ph.D. in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required and 2 years of experience
• Expert knowledge of international GMPs/ requirements of multiple regulatory agencies
• Strong technical background within quality compliance
• Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.
• Accountable for actions, drives results, and learns from mistakes
• Demonstrates good judgment and logical thought processes in collecting and synthesizing relevant data and information to make independent and timely decisions
• Communicates, influences, and escalates issues and decisions, as appropriate
• Demonstrates tolerance for ambiguity
• Able to travel up to 30% of the time (domestic and international travel)

Benefits

• 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