Director of Compliance & Validation at Design Group leading capital projects in life sciences. Supporting clients in regulatory compliance with a team of validation professionals.
Responsibilities
You'll work individually and in teams to support capital projects and implement solutions for our clients
Together, you will help our clients make critical changes to improve their performance and realize their most important goals
Lead a team of validation professionals and interface with clients
Provide subject matter expertise in the validation of a variety of utility, facility, and process equipment
Develop project scope statements, estimates, and proposals
Lead regional business development efforts and expand engagements with existing clients
Work on multiple projects simultaneously
Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team
Requirements
A minimum of ten years of experience with increasing responsibility in validation/quality service and project management of life sciences, biotech, or other FDA regulated projects
Diverse experience leading CQV project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation (preferred)
The ability to read engineering documents and experience in proposal development
A solid understanding of EPCMV, Quality by Design, and risk analysis methods including FMEA, HAZOP and Fault Tree Analysis (preferred)
An understanding of good documentation practices, cGMP, and FDA validation methods and systems
A working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance, and the latest industry expectations for data integrity
Strong project management software and word processing skills, and solid technical writing skills
A passion for a career in the life science industry
Experience in mentorship, multi-discipline collaboration, and in a consulting and service environment
A willingness to travel for project requirements including project installation and start-up activities, client and company sponsored meetings, trainings, industry related seminars, forums, and conventions
A bachelor of science in engineering or a related technical degree.
Business Development Lead at Intel, connecting customer needs to product innovation in neuromorphic computing. Engaging with industry and academia to drive ecosystem growth.
Senior Business Development Manager focusing on B2B and Partner collaborations for EV charging in Germany. Targeting partner network expansion, business acquisition, and sales growth.
Business Development Executive at OneDigital, developing new business opportunities and closing sales. Collaborating with teams to achieve aggressive revenue goals while improving the wellbeing of people.
Senior Business Development Manager at Sokin engaging mid - market and enterprise clients. Sokin is a B2B financial services provider simplifying global payments.
Senior Business Development Manager at Sokin engaging with corporate clients in the mid - market and enterprise segments. Responsible for sourcing and qualifying high - value business opportunities.
Senior Business Development Manager driving corporate client engagement at Sokin. Focusing on global payments and financial solutions for mid - market and enterprise segments.
Business Development Representative focusing on expanding healthcare services and driving growth. Building strong relationships with clients and community partners to enhance patient engagement and service offerings.
Business Development Representative expanding healthcare services footprint by identifying and cultivating new business opportunities. Building relationships with clients and community partners to drive growth in behavioral health care.
Business Development Representative at Lakeview Health expanding healthcare services by identifying new opportunities. Fostering relationships with clients and community partners to enhance patient engagement.