Director, Enterprise Regulatory Compliance

Scorpion Therapeutics; Cornelia (GA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Vacation 120 hrs/yr

Sick time 40 hrs/yr

Holiday incl. floating 13 days/yr

Work/Personal/Family Time 40 hrs/yr

Parental Leave 480 hrs

Bereavement 240 hrs immediate

Caregiver Leave 80 hrs

Volunteer Leave 32 hrs/yr

Military Spouse Time-Off 80 hrs/yr

Job summary

Scorpion Therapeutics seeks an experienced Enterprise Regulatory Compliance leader to act as the single point of contact for policy interpretation, issue triage, and decision support across pharma and medical device businesses.

You will lead risk assessments, inspections readiness, and health authority responses, build AI-assisted processes, and guide cross-functional teams while traveling up to 20% as needed.

Qualifications

• 10+ years regulatory compliance experience.
• cGMP regulatory compliance in pharma/medical devices.
• Health Authority/Notified Body experience preferred.
• Willing to travel up to 20%.

Responsibilities

• Serve as single point of contact for policy interpretation and issue triage.
• Provide independent assessments of manufacturing, quality, and compliance risks.
• Review Health Authority inspections and cGMP audits for consistency.
• Lead issue management for inspections and recalls per policies.
• Support inspection readiness for Health Authority and Notified Body audits.
• Review FDA responses for completeness and alignment.
• Analyze regulatory data and lead data-driven reviews for executives.
• Build AI literacy and use approved AI tools to improve analysis and checks.
• Lead oversight for significant escalations and coordinate actions.
• Support audits, due diligence, and acquisition compliance assessments.
• Provide consultative expertise on health authority actions.
• Deliver cGMP training on risk-based auditing strategies.

Skills

Regulatory leadership

Policy interpretation

Data-driven analysis

Cross-functional leadership

Communication skills

AI literacy

Auditing knowledge

Education

Bachelor's degree

Advanced degree preferred

Tools

AI tools

Job description

Key Responsibilities:

• Serve as Enterprise Regulatory Compliance single point of contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharma and medical device businesses.
• Provide independent assessments of manufacturing, quality, and compliance risks; ensure consistent application of global regulations and company standards across segments and sites.
• Review and classify Health Authority inspections and corporate cGMP audits for consistency.
• Review/initiate issue management for inspections and recalls following escalation policies and standards.
• Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.
• Review US FDA response reviews (as assigned) for completeness, quality, and alignment to requirements.
• Analyze regulatory compliance data and lead periodic data-driven compliance reviews for senior executives.
• Build AI literacy and use approved AI tools to improve analysis, synthesis, documentation, and quality checks (aligned with governance/privacy/responsible AI).
• Lead oversight/governance for significant compliance escalations and coordinate required actions/communications.
• Support audits, due diligence, and acquisition compliance assessments; develop strategic plans aligned to enterprise objectives.
• Provide consultative expertise on compliance issue management and health authority responses/field action decisions.
• Deliver cGMP training on risk-based auditing strategies.

Qualifications:

• Bachelor’s degree required; advanced degree/certification preferred.
• 10+ years relevant quality and compliance experience required.
• Prior cGMP regulatory compliance experience in medical device and/or pharma required.
• Health Authority/Notified Body experience preferred.
• Strong written/oral communication; leadership track record in cGMP compliance; ability to influence cross-culturally and across all org levels; thrive in complex matrix.
• Up to 20% domestic/international travel.

Preferred Skills:

• Advanced Analytics
• Audit and compliance trends
• compliance management/risk
• confidentiality
• controls compliance
• internal auditing
• investigation techniques
• policy development
• report writing
• tactical planning
• technical credibility
• mentoring/developing others.

Benefits (time off):

• Vacation (120 hrs/yr)
• Sick time (40 hrs/yr; CO:48; WA:56)
• Holiday incl. floating (13 days/yr)
• Work/Personal/Family Time (up to 40 hrs/yr)
• Parental Leave (480 hrs within one year)
• Bereavement (240 hrs immediate; 40 hrs extended)
• Caregiver Leave (80 hrs/52 weeks; incl. 10 days)
• Volunteer Leave (32 hrs/yr)
• Military Spouse Time-Off (80 hrs/yr).