· industry criteria: consumer goods
· domain: sarbanes oxley act knowledge
· function: finance & accounting
· geographic focus: us
· previous experience/ past organizations worked with: mondelez, unilever, nestle, kellogg’s
· years of experience: 10+
· key specialization: sox, icfr, global implementation, sox designing, sox optimization
· key responsibilities:
what are the factors every company going through large transformations around managing sox compliance bear in mind
how call can technology help in building a centre of excellence which shall provide visibility to the corporate and in country management
how does stat auditor respond to the setting up in terms of relying on work done by others?
Which all areas can sox controls be optimized more than not
how can one integrate the sox with other internal control programs
· duration of engagement: 12 weeks+9 Other Responses
Quality Management System
Our client has a quality assurance & regulatory compliance manager position in mahwah, new jersey
the manager, quality assurance & regulatory compliance will ensure overall quality
management system (qms) compliance with applicable regulatory and statutory requirements.
The successful candidate will manage the manufacturing site’s internal and external audit
functions and will coordinate activities of third party audits /visits. In addition, the manager,
quality assurance & regulatory compliance will be responsible for leading and managing a group of quality professionals to ensure a high level of quality management system and regulatory compliance in the plant. This position will be responsible for quality management system improvement, procedure development, and qms implementation. The manager will coordinate management review, capa, ncrb, complaints, product field actions, and related document control functions.
Detailed responsibilities of the manager, quality assurance & regulatory compliance include, but are not limited to the following:
*ensure overall qms system compliance with applicable regulatory and statutory requirements.
*perform internal quality assurance audits to 21cfr 820, iso 9001:2000, iso
13485:2003, 93/42/eec and other applicable standards to ensure corporate and
*develop and conduct effective training programs on related qa topics.
*conduct and support benchmarking activities.
*identify areas of opportunity and support continual improvement of the quality
identify, develop, and report qms metrics.
*manage internal audits, capa system, complaint handling (investigation/resolution),
a bachelor's degree in a scientific or other relevant field is required. A master's degree or equivalent additional coursework is desirable. Internal or lead auditor certification (cqa) is preferred. A minimum of 5 years of experience managing a team is also required. 3 years of experience in a quality role in the medical device industry is also desired.
Ideal candidates should also possess the following skills/experiences:
applied understanding of cgmps, iso 9001, iso 13485, and fda qsr.
*demonstrated ability to effectively lead cross-functional/cross-plant project teams using
relevant project management tools such as ms project.
*demonstrated experience developing quality management systems, designing and
developing training programs/courses.
Experience with lean and six sigma methodology and tools.
*demonstrated auditing experience in medical device or other regulated manufacturing
environment (biotech, pharma, military, aerospace, automotive).+5 Other Responses
Internal Audit And Compliance Software
We are looking to speak with paid customers/users of internal audit and compliance software. We want to have a better understanding of your use case, purchasing considerations and evaluation of other vendors in this space.This would be for a 1-hour paid phone consult. Please respond with a few short statements to the questions below.1. Were you the person personally responsible for evaluating, selecting and implementing internal audit and compliance software in your organization? Please comment on the extent of your involvement in the decision-making process.2. Are you able to speak on the platform's features and functionality? Please comment on your use case.3. Did you also evaluate other competitors? Are you also familiar with soxhub or auditboard?+47 Other Responses