Director, Enterprise Regulatory Compliance

Scorpion Therapeutics; Horsham (PA); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Vacation time: 120 hours/yr

Sick time: 40 hours/yr

Holiday pay: 13 days/yr

Parental Leave: 480 hours/yr

Bereavement: 240 hours/yr

Volunteer Leave: 32 hours/yr

Job summary

Scorpion Therapeutics is seeking a Director of Enterprise Regulatory Compliance to lead policy interpretation, issue triage, and risk assessment across pharmaceutical and medical device businesses.

The role will independently review inspections, manage health authority responses, and drive data-driven compliance reviews for senior leadership, with potential for up to 20% travel and cross-site collaboration.

Qualifications

• Bachelor’s degree required.
• 10+ years of quality and compliance experience.
• cGMP regulatory experience in medical device/pharma required.
• Experience with Health Authority or Notified Body preferred.

Responsibilities

• Serve as Enterprise Regulatory Compliance Single Point of Contact and SME for policy interpretation and issue triage.
• Assess manufacturing, quality, and compliance risks and ensure global regulations are applied consistently.
• Review and classify Health Authority inspections and cGMP audits.
• Lead issue management for health authority inspections and recalls.
• Support inspection readiness for Health Authority and Notified Body audits.
• Review FDA responses for completeness and alignment with requirements.
• Analyze regulatory compliance data and lead data-driven reviews for leadership.
• Lead governance for compliance escalations and communications to executives.
• Participate in audits, due diligence, and acquisition compliance assessments.
• Provide consultative expertise on compliance issue management and field actions.
• Provide cGMP training on risk-based auditing.

Skills

Advanced analytics

Audit/compliance trends

Investigation techniques

Compliance management

Policy development

Report writing

Mentoring/developing others

Confidentiality

Legal function knowledge

Education

Bachelor's degree

Advanced degree preferred

Job description

Director, Enterprise Regulatory Compliance (Quality & Compliance)

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; support consistent application of global regulations, company standards, and policies across segments and sites.
• Independently review and classify Health Authority inspections and corporate cGMP audits.
• Independently 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 with requirements.
• Analyze regulatory compliance data; lead periodic data-driven compliance reviews for senior leadership.
• Build AI literacy and apply approved AI-enabled tools for analysis, synthesis, documentation, and quality checks (aligned with governance, privacy, and responsible AI expectations).
• Lead enterprise interpretation/oversight/governance for compliance escalations, including alignment on actions and communications to senior leadership.
• Participate in audits, due diligence, and acquisition compliance assessments; develop strategic plans aligned to enterprise objectives.
• Provide consultative expertise on compliance issue management, including health authority responses and field action decisions.
• Provide cGMP training on risk-based auditing strategies.

Qualifications

• Bachelor’s degree minimum.
• Advanced degree or certification preferred.
• 10+ years relevant quality and compliance experience.
• cGMP regulatory compliance experience in medical device and/or pharmaceutical regulations required.
• Work experience with a Health Authority or Notified Body preferred.
• Strong communication skills; leadership track record; ability to influence across cultures/functions without line authority; ability to thrive in a matrix environment; up to 20% travel.

Preferred Skills

• Advanced analytics; audit/compliance trends; investigation techniques; compliance management/risk; internal auditing; policy development; report writing; mentoring/developing others; controls compliance; confidentiality; tactical planning; technical credibility; legal function/legal services.

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

• Vacation: 120 hours/year; Sick time: 40 hours/year (Colorado: 48; Washington: 56)
• Holiday pay (floating): 13 days/year
• Work, Personal and Family Time: up to 40 hours/year
• Parental Leave: 480 hours within one year; Bereavement: 240 immediate / 40 extended per year
• Caregiver Leave: 80 hours in a 52-week rolling period; Volunteer Leave: 32 hours/year; Military Spouse Time-Off: 80 hours/year