Compliance Coordinator

Position Summary

The Compliance Coordinator supports inspection-ready compliance systems across Empower’s 503A and 503B operations. This individual contributor owns auditing company procedures and protocols mandated by federal and state regulators. Success means FDA and state inspections conclude without systemic findings, deviation rates decline relative to production growth, CAPAs prevent recurrence, and compliance infrastructure scales ahead of expansion. The role applies artificial intelligence as a daily force multiplier to increase monitoring speed, enhance decision quality, automate low-leverage review work, and forecast inspection risk. Operating with high autonomy and measurable accountability, this role partners cross-functionally with Quality, Operations, and licensing to support and audit embed regulatory controls at design stage rather than after failure. The Compliance Coordinator protects patient safety, facility licensure,and brand trust by review and ensure Empower adheres to regulatory complexity into structured systems, quantified risk models, and defensible execution standards.

Duties and Responsibilities

Enterprise Regulatory Control Architecture

• Audit compliance control frameworks across multi-site 503A and 503B sterile operations to sustain inspection readiness.
• Remain current on federal and state laws and regulations to address organizational business needs.
• Monitor regulatory changes and support translation of FDA, USP, and state requirements into operational controls.
• Maintain and organize an inspection-ready compliance library, including licenses, permits, policies, training files, vendor and third-party records, audit reports, and CAPAs.
• Assist in locating controlled documents during audits and regulatory inspections.
  
  

Deviation, CAPA, and Risk Suppression

• Support rigorous root cause investigations that eliminate systemic causality and measurably reduce recurrence across facilities.
• Track CAPA lifecycle velocity through structured timelines, effectiveness checks, and proactive barrier removal.
  
  

Cross-Functional Regulatory Influence

• Embed regulatory controls into product launches, facility expansions, and process changes at design stage.
• Issue written compliance positions outlining regulatory basis, quantified risk exposure, and recommended action.
• Design targeted behavior correction interventions tied to documented deviation patterns and measurable outcomes.
  
  

AI-Enabled Compliance Transformation

• Deploy AI tools to analyze batch records, deviation narratives, and environmental monitoring datasets for anomaly detection at scale.
• Build regulatory intelligence workflows that synthesize enforcement trends into prioritized internal control enhancements.
• Implement automated record review systems that reduce manual review hours while increasing detection sensitivity.
  
  

Inspection Readiness and Scalable Impact

• Own high-consequence compliance initiatives end to end, defining measurable success metrics tied to inspection outcomes.
• Install personal operating systems including dashboards, risk reviews, and documented decision logs to ensure disciplined execution.
• Represent compliance during audits with evidence-based precision, factual clarity, and composure under scrutiny.
  
  

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

Knowledge and Skills

• Knowledge of FDA regulations, cGMP, USP standards, sterile compounding controls, state regulations and can support
• Strong organizational skills with ability to maintain audit-ready documentation systems and regulatory libraries.
• Proficiency leveraging AI tools for anomaly detection, regulatory intelligence synthesis, predictive risk modeling, and automation of documentation review workflows.
• Advanced analytical, written communication, and cross-functional influence skills with the ability to provide overviews of regulatory deficiencies to support leadership in translating complex regulatory requirements into operationally executable controls.
  
  

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
  
  

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.
  
  

Experience And Qualifications

• Bachelor’s degree required.
• 5 years of professional experience in compliance, regulatory affairs, quality systems, or related field.
• Experience in healthcare, pharmaceutical, manufacturing, or other regulated industry preferred.
• Ability to apply data analytics or AI tools to improve execution speed, decision quality, or process automation strongly preferred.
• Proven ability to operate independently in high-growth, high-accountability environments.
  
  

Benefits

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/