When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

POSITION SUMMARY: As a member of the BioServices & Specialty Logistics (BSL) organization, this position will have the opportunity to join a growing and dynamic team at the forefront of innovation within the Clinical Trials Division. This role will be a key contributor to the BSL quality team, specifically related to the Patheon Logistics business and will act as the Controlled Substances Coordinator and support the DEA compliance profile for the Patheon Logistics business in North America. Additionally, this will include consulting on regulatory framework for the transportation/global business as needed. Under the direction of the Senior Quality Manager – Transportation & Logistics, the Regulatory Manager is primarily responsible for development and execution of new processes relating to DEA & TSA compliance, state licensure management and other factors which have regulatory impact on the pharmaceutical distribution business and ensure that these dynamic service lines are implemented and maintained in a compliant fashion.

This role will act as the Controlled Substances Coordinator and support the DEA compliance profile for the Patheon Logistics business in North America

WORK SCHEDULE: 8:00am – 5:00pm core hours. May be required to work some overtime and weekend hours.

TRAVEL: This position will limited travel estimated 10-20%

KEY RESPONSIBILITIES:

• Management of DEA and TSA responsibilities for both facilities including hosting inspections as needed.
• Implement and maintain SOPs that adhere to PSG and Thermo Fisher policies for the Patheon Logistics business as well as developing/improving appropriate local processes where needed. This will include working with relevant stakeholders to align on requirements.
• Act as the Controlled Substances Coordinator for the Memphis, TN and Swedesboro, NJ facilities.
• Be responsible for oversight of accurate and consistent documentation and execution on the execution of all CS transactions e.g. cage checkout/in, inventory reconciliation, record keeping, etc.
• Ensure alignment between site level SOPs and DEA/TSA and other regulatory requirements
• Complete and maintain DEA 106 Forms and other official documentation such as inspection readiness packs
• Apply for and maintain current DEA, State Licensure, VAWD and TSA registrations
• Prepare and submit regular DEA, State, FDA and TSA reporting as required (e.g. ARCOS reporting).
• Assist in the development and growth of a DEA security culture at the site for colleagues and contractors to ensure DEA compliance. This includes but not limited to developing and delivering training to employees.
• Support the internal audit process by coordinating the relevant audits of the controlled substances processes as necessary.
• Generate and report metrics/KPIs to the leadership team regarding DEA, TSA and state licensure compliance levels
• Work as a leader for the Patheon Logistics quality team and provide assistance and support to the overall quality management system as it pertains to regulatory inputs.
• Manage state licensure for Patheon Logistics facilities including but not limited to coordinating the requirements for each state, managing and maintaining the expiry/renewal process.
• Manage the relationship with any and all vendors employed with Patheon Logistics to assist with the regulatory processes e.g. licensure management.
• Facilitate regulatory reviews for Patheon Logistics and work with global quality as the business expands into new service lines and increases visibility to other agencies such as the FDA.
• Ensure operation under GxP principles and standards as well as coordination with the wider Pharma Services Group policies and procedures within the organization.
• Demonstrates and promotes the company vision.
• Ownership of change management including specific quality action items within Patheon Logistics associated with these services.
• Work with relevant business Unit leaders to facilitate integration of new Transportation/Logistics services

HOW WILL YOU GET THERE?

EDUCATION

• A Bachelors Degree in a Science discipline is required.

EXPERIENCE:

• 5+ years of experience in the pharmaceutical or biotech industries
• Working knowledge of GMP/GDP principles pertaining to a pharmaceutical distribution environment
• Desired to have experience in conducting and/or hosting audits/inspections
• Previous experience in transportation/logistics roles

KNOWLEDGE, SKILLS, ABILITES

• Well-versed in DEA, TSA and state licensing regulations.
• Project planning and working knowledge of Excel, Word, Access, and quality management software
• Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly Functioning team leader and team member in a multi-skilled, dynamic business environment
• Leadership skills: Proven ability to influence others, lead significant change and negotiate for win/win outcomes
• Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making
• Strong communication skills both written and verbal

NON-NEGOTIABLE HIRING CRITERIA:

• Must be able to meet all requirements for handling of controlled substances including passing relevant background checks
• Computer literacy with an understanding of Microsoft Windows applications
• Ability to maintain a high level of accuracy and attention to detail.
• Ability to work independently and possess problem solving ability

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

As the world’s leader in serving science, Thermo Fisher Scientific's professionals develop critical solutions—and build rewarding careers. They help customers in finding cures for cancer, protecting the environment, making sure food is safe, and so much more. When you #StartYourStory with Thermo Fisher, you are guaranteed meaningful work - both personally and professionally.