Director, Enterprise Regulatory Compliance

Scorpion Therapeutics; Washington (District of Columbia); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Vacation

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Caregiver Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Scorpion Therapeutics seeks a Director of Enterprise Regulatory Compliance to serve as the single point of contact for policy interpretation, risk assessment, and issue management across pharma and medical devices. You will review inspections, support audit readiness, and drive data-driven compliance decisions.

You will lead cross-functional teams, apply AI-enabled tools, and guide governance of major escalations with strong communication and strategic planning. Travel up to 20% is expected.

Qualifications

• 10+ years relevant quality/compliance experience required.
• Health Authority/Notified Body experience preferred.
• cGMP regulatory compliance experience in medical device and/or pharma required.
• Strong written and oral communication; leadership in cGMP compliance; matrix environment capable.
• Up to 20% domestic/international travel.

Responsibilities

• Serve as Enterprise Regulatory Compliance Single Point of Contact for policy interpretation, issue triage, and decision support.
• Provide independent assessments of manufacturing quality and compliance risks.
• Review and classify Health Authority inspections and cGMP audits for consistency.
• Initiate issue management for inspections and recalls per escalation policies.
• Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.
• Review FDA responses for completeness, quality, and alignment.
• Analyze compliance data to produce actionable insights and lead reviews.
• Apply AI-enabled tools to improve governance and decision processes.
• Lead oversight/governance for significant escalations and actions.
• Support audits, due diligence, and acquisition compliance assessments; develop strategic plans.

Skills

Advanced Analytics

Audit/Compliance Trends

Audit Findings/Recommendations

Compliance Management/Risk

Confidentiality

Controls Compliance

Developing Others

Internal Auditing

Investigation Techniques

Legal Function/Services

Mentorship

Policy Development

Report Writing

Tactical Planning

Technical Credibility

Education

Bachelor’s degree

Advanced degree/certification

Job description

Director, Enterprise Regulatory Compliance (Enterprise Regulatory Compliance Assessment)

Responsibilities:

• Serve as Enterprise Regulatory Compliance Single Point of Contact for policy interpretation, issue triage, and decision support across pharma and medical devices.
• Provide independent assessments of manufacturing, quality, and compliance risks to support consistent application of regulations, standards, and policies.
• Review and classify Health Authority inspections and corporate cGMP audits for consistency.
• Initiate issue management for inspections and recalls following escalation policies/standards.
• Support inspection readiness for Health Authority and Notified Body audits and pre-approvals.
• Review assigned US FDA response reviews for completeness, quality, and alignment.
• Analyze compliance data to produce actionable insights and lead data-driven compliance reviews.
• Apply approved AI-enabled tools to improve ways of working (consistent with governance/privacy/responsible AI expectations).
• Lead oversight/governance for significant compliance escalations and align required actions/communications.
• Support audits, due diligence, and acquisition compliance assessments; develop strategic plans.
• Provide consultative expertise on compliance issue management and health authority/field action decisions.
• Provide cGMP training on risk-based auditing for key issues and trends.

Qualifications:

• Bachelor’s degree minimum.
• Advanced degree/certification preferred.
• 10+ years relevant quality/compliance experience required.
• Health Authority/Notified Body experience preferred.
• cGMP regulatory compliance experience in medical device and/or pharma required.
• Strong written/oral communication; demonstrated leadership in cGMP compliance; relationship building/influence without line authority; ability to work across all levels; self-directed in a matrix environment.
• Up to 20% domestic/international travel.

Preferred Skills:

• Advanced Analytics
• Audit/Compliance Trends
• Audit Findings/Recommendations
• Compliance Management/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):

• Vacation 120 hrs/yr
• Sick time 40 hrs/yr (CO 48; WA 56)
• Holiday pay (incl. floating) 13 days/yr
• Work/Personal/Family Time up to 40 hrs/yr
• Parental Leave 480 hrs/yr
• Bereavement Leave 240 hrs (immediate) and 40 hrs (extended)/yr
• Caregiver Leave 80 hrs in 52-week rolling period
• Volunteer Leave 32 hrs/yr
• Military Spouse Time-Off 80 hrs/yr.