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Hybrid Associate Director, Compliance

at MSD
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Posted 4 weeks ago

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About the role

  • 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

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

HybridMillsboroUnited States

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