Associate Director, Compliance
MSD
full-time
Posted on:
Location Type: Hybrid
Location: Millsboro • 🇺🇸 United States
Visit company websiteSalary
💰 $139,600 - $219,700 per year
Job Level
Senior
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Management System (QMS)GxP complianceUSDA complianceauditingrisk-based approachregulatory trendsscientific disciplinemicrobiologybiochemistrypharmacology
Soft skills
listeninggathering perspectivesdeveloping solutionsaccountabilitydriving resultsgood judgmentlogical thought processescommunicationinfluencingtolerance for ambiguity