The Compliance Manager will develop, implement, maintain, and continually assess The Apothecary Shoppe’s compliance with internal company standards and external regulatory and customer requirements.
CORE JOB DUTIES AND RESPONSIBILITIES
- Develop, from the ground up, a comprehensive compliance program for all of The Apothecary Shoppe’s processing and manufacturing operations
- Implement, maintain, and continually assess and improve The Apothecary Shoppe’s compliance program
- Collaborate with The Apothecary Shoppe’s leadership team for planning, execution, and oversight of the regulatory and internal compliance.
- Define, develop, and implement short-term and long-term strategies, goals, objectives, and tactics relating to compliance.
- Subject matter expert on regulatory compliance as related to manufacturing and processing cannabis in the state of Florida
- Knowledgeable on all safety regulations including OSHA, State of Florida and local municipalities
- Monitors all production activities from a compliance perspective to ensure compliant operations and safe products for patients
- Leads safety initiatives to ensure a safe working environment for our employees
- Maintains and leads process for manufacturing team SOP development including interfacing with R&D for new products and processes
- Works with technicians to integrate feedback into SOPs
- Maintains all necessary permits for manufacturing and the manufacturing facility
- Provides leadership on certification processes including Food Safety, GMP and ISO as required
JOB SKILLS AND REQUIREMENTS
- 5+ years in highly regulated environments and exposure to compliance functions
- Prior experience working with, developing, implementing, and managing a compliance program.
- Experience in an FDA-regulated industry (including pharmaceuticals, medical devices, or bioprocessing) and aseptic manufacturing is preferred.
- Experience with cGMP, cGPL, and/or related compliance programs.
- Ability to work in a fast-paced, changing, and challenging environment.
- Analytically and communicatively intelligent.
- Focuses simultaneously on short- and long-term goals; ability to identify problems quickly.
- Knowledge of customer service, inventory management (including software) and regulatory compliance.
- Accurate data-entry and record keeping.
- Strong attention to detail, organizational skills and time management abilities.
- Ability to pass a background check, including drug testing, to be registered as an employee of a licensed organization in Florida, Texas, and/or other Surterra geographies
- Comfort with security protocols, including video monitoring and employee tracking.
- An ability to travel up to 25% of the time.
- Bachelor’s degree; advanced degree preferred.
- The ability to lift 20-50 pounds as needed.
- The ability to move safely over uneven terrain or in confined spaces.
- The ability to perform various physical activities, including lifting, standing, and squatting.
- The ability to work in extreme weather.
- The ability to wear personal protective gear during portions of the day.
6 CORE VALUES OF A SURTERRA EMPLOYEE
• Integrity - We operate in a regulated and unchartered industry. Act and make decisions that stand up to scrutiny and reflect our position as a sophisticated, credible and respected leader. Be honest, trustworthy, dependable, and honorable. Demonstrate sound moral and ethical ways of interacting.
• Collaboration - We are a collection of the best talent at all levels. Learn and grow from this diversity: welcome healthy debate and proactively seek other perspectives and points of view to find the best solution while not resting on consensus. Proactively ensure the right people have the right information at the right time. Work as a team vs. an individual performer.
• Agility - We are growing incredibly fast in a new industry. Be open to change, be ready to pivot on the moment’s notice, and act with a sense of urgency to take advantage of opportunities. Then be ready to do it again. Quickly –and calmly -respond and adapt to the unexpected. Modify and streamline processes, find more efficient ways of doing your job. Work efficiently across markets, time zones, and functions.
• Intentionality - Intentionality requires action –it makes your intentions happen. Good thoughts are meaningless without action. It is initiative directed by the purpose to move our business forward. Intentionality is doing things important to you, even when not easy. Transformational change happens with intentionality.
• Alignment - Together, we must understand and believe in our vision, mission, business and team goals and priorities. When we make a decision, even when we don’t have consensus we all align behind that decision and execute. We don’t revisit decisions unless we have material new data or circumstances.
• Accountability - Make the best proactive and reactive decisions given the available information and the wisest counsel. • Own your decisions, actions and outcomes, and promptly correct mistakes. • Be reliable, honor commitments and do not finger point, off- load responsibilities, or criticize co-workers. Look after co-workers and team’s success.