Director of Compliance

Director of Compliance

Galt Pharmaceuticals is a purpose-driven organization dedicated to improving the quality of life for patients by providing products that address unmet clinical needs. We empower entrepreneurs support our employees and make a positive impact in the communities we serve. We are seeking a highly motivated self-starting Director of Compliance to join our growing team!

This is a full-time salaried position offering a comprehensive benefits package including medical coverage paid time off and holiday pay! We provide a flexible and collaborative work environment with hybrid coworking and flex office space options! Galt features a 4-day work week (Monday through Thursday with Fridays off!) and our office is conveniently located in the Atlanta Metro area!

Position Overview:

Reporting to the Chief Executive Officer & Co-Founder as the Director of Compliance you will design implement and oversee Galts ethics and compliance program ensuring adherence to a dynamic landscape of federal state and international laws and regulations. This leadership role is critical to mitigating legal and financial risks preventing misconduct and promoting a strong culture of ethical conduct across the -depth knowledge of FDA OIG EMA DOJ Medicare/Medicaid regulations and a strong understanding of healthcare laws such as the Anti-Kickback Statute False Claims Act PDMA GMP GCP and Sunshine Act is required. Candidates with contract management experience are encouraged to apply.

Responsibilities:

• Program Management: Develop execute and continuously improve the corporate compliance program across all business units.
• Risk Assessment & Mitigation: Identify compliance risks and vulnerabilities; conduct audits and reviews; develop corrective action plans; implement preventative strategies.
• Regulatory Monitoring: Stay abreast of evolving laws regulations and industry trends from regulatory bodies (FDA EMA DOJ OIG etc.) and industry codes (e.g. PhRMA Code). Ensure manufacturing and vendor relationships are compliant.
• Policy Development: Draft update and maintain compliance policies SOPs and the corporate code of conduct.
• Training & Communication: Lead the development and delivery of compliance training for employees and third parties; foster a culture of compliance through clear effective communication.
• Internal Investigations:Oversee or assist in investigations of potential compliance violations; document findings and ensure appropriate corrective action.
• Stakeholder Collaboration: Serves as a liaison between outside counsel and/or consulting services; serves as a strategic partner and compliance advisor to senior management legal counsel medical and regulatory affairs and cross-functional teams; represent Galt during regulatory inspections and client audits.
• Reporting: Prepare and present reports on compliance activities program effectiveness and risk metrics to senior leadership and compliance committees.
• Compliance and Administration: Ensure contracts programs business initiatives comply with corporate policies legal requirements and industry regulations and maintain organized records.
• Manages personnel as required.
• Performs other duties as assigned.

Professional Qualifications:

• Bachelors degree in a relevant field (science law business administration or related discipline).
• Minimum 5 years experience in the pharmaceutical healthcare or biotech industry with at least 35 years in a compliance leadership or managerial role.
• Pharmaceutical Compliance Certification (Certified Pharmaceutical Industry Professional (CPIP) Certified in Healthcare Compliance (CHC) or Good Manufacturing Practices (cGMP) Certified Professional etc.) is preferred.
• Experience with federal reimbursement discounts rebates and pricing is a plus.
• Proven leadership skills and experience managing teams and cross-functional projects.
• Self-starter with the ability to work independently and proactively with minimal supervision.
• Exceptional verbal and written communication skills; demonstrated ability to translate complex regulations into clear policies and effective training.
• Strong analytical and problem-solving abilities particularly in risk assessment and solution development.
• High ethical standards and integrity with the ability to build trust and credibility across all stakeholders.

Employment Requirements:

• Must pass a background check.
• Must be legally authorized to work in the United States.

Whats the Culture like at Galt

Were not your traditional pharmaceutical company! At Galt our company culture is dynamic employee-focused and entrepreneurial. We take pride in offering a career experience that makes you eager to come to work every day. Our environment is built on continuous improvement fueled by collaboration and diverse perspectives where challenging problems are solved together!

At Galt youll find daily opportunities to learn grow and inspire those around you. Youll join a team of self-starters each motivated to make a real impact in every interaction. We value flexibility with work hours and understand the importance of life outside the office empowering you to achieve your best both professionally and personally!

Below are a few perks of joining our Team:

• 4-day work week: Monday through Thursday with Fridays off
• Collaborative passionate and intelligent team
• Culture of creative problem solving and entrepreneurial thinking
• Fast-paced and engaging environment
• Solution-driven low-ego workplace
• Regularly catered lunches for the team

Benefits:

• 401(k) retirement savings plan
• Comprehensive Medical Dental and Vision Insurance
• Life and Disability Insurance coverage
• Health Savings Account (HSA) option
• Flexible Spending Account (FSA) option
• Employee Assistance Program (EAP)
• Flexible Paid Time Off (PTO)
• Paid company holidays
• And more!

Required Experience:

Director