Merck
Executive Director of Global Auditing
The Executive Director of Global Auditing will report to the Head of Global Quality Compliance Support. The responsibility of this position crosses Human and Animal Health operating units and requires extensive collaboration with manufacturing sites, contractors, and suppliers. Primary Responsibilities: Lead global team of GxP auditing experts to ensure our company's manufacturing sites, contractors, and suppliers adhere to the highest quality and compliance standards Develop and maintain global Quality Management System (QMS) documents pertaining to auditing and inspections; ensure team and company adherence to these documents Develop a risk-based audit schedule for our company's auditable entities and ensure schedule adherence Ensure audits are conducted to assess compliance with applicable 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 auditors to ensure their ongoing skills development and ability to detect and communicate GxP compliance concerns Ensure fiscal responsibility while maintaining budget for global auditing team 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. 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 observed during audits. 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 Education Requirement: B.S., M.S., and/or Ph.D. in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required. Required Experience and Skills: A minimum of 10 years of quality, operational, or technical experience within the GMP regulated environment Expert knowledge of GMPs and regulatory requirements and expectations. Strong technical background 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 Communicates effectively up and down, at all levels of the organization Demonstrates tolerance for ambiguity Expert knowledge of international GMPs/requirements of multiple regulatory agencies Able to travel up to 30% of the time Preferred Experience and Skills: A minimum of 15 years of quality, operational, or technical experience within the GMP regulated environment A minimum of 5 years of auditing experience A minimum of 5 years leading complex or global teams Strong background in data analytics Strong background and technical understanding of vaccines and/or biologics, aseptic techniques, and analytical techniques. Experience working for a health authority/board of health as an inspector, product reviewer, compliance officer, or other GMP/regulatory role
The Executive Director of Global Auditing will report to the Head of Global Quality Compliance Support. The responsibility of this position crosses Human and Animal Health operating units and requires extensive collaboration with manufacturing sites, contractors, and suppliers. Primary Responsibilities: Lead global team of GxP auditing experts to ensure our company's manufacturing sites, contractors, and suppliers adhere to the highest quality and compliance standards Develop and maintain global Quality Management System (QMS) documents pertaining to auditing and inspections; ensure team and company adherence to these documents Develop a risk-based audit schedule for our company's auditable entities and ensure schedule adherence Ensure audits are conducted to assess compliance with applicable 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 auditors to ensure their ongoing skills development and ability to detect and communicate GxP compliance concerns Ensure fiscal responsibility while maintaining budget for global auditing team 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. 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 observed during audits. 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 Education Requirement: B.S., M.S., and/or Ph.D. in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required. Required Experience and Skills: A minimum of 10 years of quality, operational, or technical experience within the GMP regulated environment Expert knowledge of GMPs and regulatory requirements and expectations. Strong technical background 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 Communicates effectively up and down, at all levels of the organization Demonstrates tolerance for ambiguity Expert knowledge of international GMPs/requirements of multiple regulatory agencies Able to travel up to 30% of the time Preferred Experience and Skills: A minimum of 15 years of quality, operational, or technical experience within the GMP regulated environment A minimum of 5 years of auditing experience A minimum of 5 years leading complex or global teams Strong background in data analytics Strong background and technical understanding of vaccines and/or biologics, aseptic techniques, and analytical techniques. Experience working for a health authority/board of health as an inspector, product reviewer, compliance officer, or other GMP/regulatory role