Director, Enterprise Regulatory Compliance

Scorpion Therapeutics; Athens (GA); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Vacation

Sick leave

Holiday pay

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Military spouse time-off

Job summary

Scorpion Therapeutics is seeking a Director of Enterprise Regulatory Compliance to act as the single point of contact for policy interpretation, issue triage, and decision support across pharmaceutical and medical device businesses.

You will lead independent risk assessments, review health authority inspections and cGMP audits, drive inspection readiness, and provide strategic guidance to senior leadership. Travel up to 20% may be required.

Qualifications

• Bachelor’s degree minimum; advanced degree/certification preferred.
• 10+ years in quality and compliance.
• Health Authority/Notified Body experience preferred (not required).
• Prior cGMP regulatory compliance experience in medical devices and/or pharmaceuticals required.
• Strong written and oral communication; leadership in a complex matrix; travel up to 20%.

Responsibilities

• Serve as Enterprise Regulatory Compliance single point of contact for policy interpretation, issue triage, and decision support across pharmaceutical and medical device businesses.
• Provide independent assessments of manufacturing, quality, and compliance risks; ensure alignment with global regulations and company standards.
• Review and classify Health Authority inspections and cGMP audits; ensure consistency across businesses.
• Review and initiate issue management for health authority inspections and recalls; support escalation policies.
• Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.
• Lead regulatory compliance data reviews for senior leadership and provide consultative expertise on issue management.
• Provide cGMP training to corporate and internal audit teams on risk-based auditing.

Skills

Leadership

Communication

Influence

Data-driven

Education

Bachelor's degree

Advanced degree or certification

Job description

Director, Enterprise Regulatory Compliance (Enterprise Regulatory Compliance Assessment)

Responsibilities

• Serve as Enterprise Regulatory Compliance single point of contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharmaceutical and medical device businesses.
• Provide independent assessments of manufacturing, quality, and compliance risks; ensure consistent application of global regulations, company standards, and policies.
• Review and classify Health Authority inspections and corporate cGMP audits; ensure consistency across businesses.
• Review and initiate issue management for health authority 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.
• Analyze regulatory compliance data and lead periodic data‑driven compliance reviews for senior leadership.
• Build AI literacy and apply approved AI tools in alignment with data governance, privacy, and responsible AI expectations.
• Lead oversight/governance for significant compliance escalations; align required actions and communications to senior leadership.
• Participate in regulatory compliance audits, due diligence, and acquisition compliance assessments; develop strategic plans and influence outcomes.
• Provide consultative expertise on compliance issue management, including support for health authority responses and field action decisions.
• Provide cGMP training to corporate and internal audit teams on risk‑based auditing.

Qualifications

• Bachelor’s degree minimum.
• Advanced degree/certification preferred.
• 10+ years relevant quality and compliance experience required.
• Health Authority/Notified Body experience preferred (not required).
• Prior cGMP regulatory compliance experience in medical device and/or pharmaceutical regulations required.
• Strong written/oral communication; leadership track record; ability to influence without line authority; thrive in a complex matrix; up to 20% travel.

Preferred Skills

• Advanced Analytics; Audit and Compliance Trends; Audit Findings and Recommendations; Compliance Management; Compliance Risk; Confidentiality; Controls Compliance; Developing Others; Internal Auditing; Investigation Techniques; Legal Function/Services; Mentorship; Policy Development; Report Writing; Tactical Planning; Technical Credibility.

Benefits (time off, subject to policy/date of hire)

• Vacation: 120 hours/year; Sick: 40 hours/year (CO 48; WA 56)
• Holiday pay (incl. floating): 13 days/year
• Work/Personal/Family time: up to 40 hours/year
• Parental leave: 480 hours; Bereavement: 240 (immediate) / 40 (extended)
• Caregiver leave: 80 hours in a 52-week rolling period (listed as 10 days)
• Volunteer leave: 32 hours/year; Military spouse time-off: 80 hours/year