Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world's leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors. Our 1,500-plus technical and engineering experts have direct industry experience in industrial automation, control system integration, facility and process engineering, architecture, construction management, regulatory compliance, enterprise technology and other consulting services.
Senior or PM level Quality professional responsible for leading projects in remediation, Quality System development, change management, process improvement, and organization master planning. Prior experience with project planning and execution, leading CAPA remediation, and/or leading organizational changes within a Life Science organization is required. This position requires a practical understanding of statistics, validation, and relevant Quality Systems standards for Pharmaceutical, Biotechnology, and/or Medical Devices.
- Responsible for day to day communication, coordination, and organization of onsite project execution activities.
- Provide leadership and mentorship to other professionals.
- Provide customized Quality solutions to clients with challenging and unique needs.
- Provide direction and guidance to clients and other professionals with regards to Quality Systems, Change Management, Investigations, and/or Process Improvement initiatives as defined by DG's clients.
- Provide review and comments to other professionals with regard to Quality impacting deliverables.
- All Design Group Project Managers have leadership skills and experience in Life Science Project Management, and have a drive and desire to grow and expand local and regional clients.
- Minimum 3 years of quality engineering or management experience.
- Must have experience managing and maintaining schedules and coordinating professionals.
- Must have experience developing Project Plans and Execution Strategies.
- Must have experience leading investigations and troubleshooting issues.
- Must have strong computer, written, and verbal communication skills.
- Understanding and experience with Validation activities is preferable.
- Pharmaceutical, Biotech and/or Medical Device project experience is required.
- Strong knowledge of FDA requirements, cGMPs, and standard QMS procedures is required.
- B.S. in Engineering, Chemistry, Microbiology or related technical degree.
- Equivalent years of experience in as a Project Manager or Quality Engineer can be substituted for degree.
- 40%-60% regional travel
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.