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Regulatory Compliance Lead Consultant Design Group

Company name
Barry-Wehmiller Design Group

Location
Minneapolis, MN

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Job Description
Design Group is a leading engineering, systems integration, and technology consulting firm, capable of providing complete operating solutions for consumer products, life sciences, and other industrial sectors.  Design Group provides engineering, project management, regulatory compliance, and other technology services to the world’s leading companies. Our organization is staffed by over 1,400 engineering and technical specialists, operating from over 40 offices in the U.S., Puerto Rico, and India. Design Group provides professional engineering, architectural and construction management services through our wholly owned and professionally licensed subsidiary, Design Group Facility Solutions, Inc. \r
We are focused on providing our professionals with opportunities for leadership and career advancement within a thriving work environment and a unique “people-centric” culture. We offer a robust, centralized learning and development program to improve the career experience for every professional. For more information, visit www.bwdesigngroup.com.\r
Barry-Wehmiller
is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $2.5 billion organization with more than 11,000 team members united by a common belief: to use the power of business to build a better world. For more information, go to www.barrywehmiller.com and visit our CEO Bob Chapman’s blog at www.trulyhumanleadership.com\r
Design
Group is currently looking for a Sr. Compliance and Validation professional for aFull time opportunity with our firm to lead our Regulatory Compliance Practice here inthe Chicago area.  The Lead will provide leadership in the development of the RegulatoryCompliance Team of professionals, quality oversight of new on ongoing projects, andserve as the primary business development professional for the practice in the Midwest.\r
Responsibilities:Our Regulatory Compliance professionals are responsible for the development, implementation, and/or remediation of Quality Systems for our clients.Typical responsibilities include aspects of: CAPA, Complaint Handling, MDRs, Design Controls, Material or Purchasing Controls, Records Management, Equipment and Facility Controls, Audits and Assessments, and Management Review.Additional responsibilities may include: Validation lifecycle documentation, including Risk Assessments, Strategic Plans, and Protocols, and execution of Protocols.The ideal candidates would have proficiency in one or more aspects listed above or of the entire Quality System.Our professionals are expected to be able to lead teams, work as an individual contributor, or as a member of a larger team.Strong communication, technical writing, and interpersonal skills are required.\r
Requirements:Development of Commissioning, Qualification, and Validation strategiesDevelopment of requisite CQV deliverables for a pharmaceutical/biotech projectFluent with current FDA guidance and direction for the industry as well as practicalapplication of those to actual projects/initiativesFluent with industry best practices for efficient and compliant CQV processes as well as practical application of those to actual projects/initiativesAble to present DG capabilities both to internal and external customersExisting pharmaceutical/biotech industry contacts and relationships that can be leveraged and translate into tangible projects/engagementsFlexibility for limited travel as needed for client and internal communication2 or more years of Quality System responsibility in Medical Device industry.Proficient with FDA Medical Device Quality System Regulations (21 CFR Part 820), ISO 13485 - Medical Devices – Quality Management Systems, and CGMPs (21 CFR 210/211).\r
Education:BS Degree in Engineering or equivalent combination of experience, training and education.Current ASQ CQA and/or PMP certification is a plus.\r
Travel:Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.\r

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Barry-Wehmiller Design Group

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