Serialization Senior Consultant
Clarkston Consulting, United States
Job Description
Do you want the opportunity to leverage your skills to make a direct impact on the world’s leading life sciences, consumer products, and retail companies? Join Clarkston Consulting as a Serialization Senior Consultant to help deliver creative business solutions to our market-leading clients as a part of our team of experienced professionals.
We are looking for motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Together, we can help find the answers to our clients most challenging business problems.
What You’ll Do
Clarkston’s Serialization Senior Consultants advise clients on domestic and global supply chain standards and compliance requirements from a risk, value (ROI creation and retention), and integrity perspective. As expert advisors, they provide regulatory analysis and solution architecture recommendations for assisting clients in achieving compliance with US Drug Supply Chain Security Act (DSCSA) and global regulatory requirements.
Candidates must have a thorough understanding of the Life Sciences industry, the DSCSA Law, and FDA Compliance requirements and of the Global regulatory landscape. Effective candidates will also have a strong ability to understand the clients’ supply chain processes and create solutions for addressing the current and future needs of the organization.
Other responsibilities will include:
- Serve as lead for addressing the complex challenges facing our clients and developing a blueprint for DSCSA and other global compliance solutions
- Serve as part of a team implementing business process improvements and solutions that address the DSCSA and global regulatory requirements for our clients
- Engage with Clarkston’s team to provide functional requirements definition, guidance and design on track and trace solutions functionality, reports, and custom interfaces
- Observe and evaluate industry trends and benchmark operations against industry standards
- Provide guidance to systems analysts and client personnel assigned to the projects
- Assist with sales pursuits, including developing proposals and participating in sales calls
- Develop thought leadership on serialization and domestic and global industry trends
How You’ll Grow
At Clarkston, we feel that we provide the greatest value to our clients through a combination of our industry expertise, business process knowledge, and consulting excellence.
Beyond your day-to-day responsibilities, throughout your career at Clarkston you will:
- Have the support and mentorship of your Clarkston colleagues and leaders
- Own your career you'll be able to take charge of your career journey with diverse opportunities to lead and expand your skillset both at the client site and within the firm
- Have the opportunity to make a real and positive impact not only the clients you work with, but on the firm as well
Requirements
What We’re Looking For:
An ideal Serialization Senior Consultant candidate would have the following qualifications and experience:
- Five (5) years of professional consulting experience in the Life Sciences industry, with advanced knowledge of DSCSA, cGMP, GMP, FDA regulations and 21 CFR Part 11,210, 211 and 820compliance
- At least one (1) full life cycle implementation of track and trace solutions like SAP ATTP, TraceLink, RfExcel, Verify Brands/Optel or others in a project lead capacity
- Deep understanding of systems development lifecycle and system implementation methodologies with expert level configuration and design skills
- Deep understanding of the global supply chain and manufacturing process, tracking, and traceability
- Understanding of blockchain technology and how it may be used in serialization
- Deep familiarity with serialization functional and technical standards, e.g., GS1, EPCIS
- Knowledge of global serialization initiative, (i.e. EU FMD, South Korea, etc.) and the associated criteria is preferred
- Excellent interpersonal, written, and oral communication skills with a demonstrated ability to gain the confidence and respect of client leadership
- Demonstrated ability to work autonomously and in a team environment
- Meaningful client services orientation and accustomed to taking an active role in executing engagements and project plans/tasks
- Excellent analytical skills and the ability to present and write at publication-quality level to communicate findings and recommendations
- 4-year degree in Business, Management Information Systems, Engineering, Computer Science or an equivalent discipline
Travel Requirement
Travel is an integral part of this role and is estimate