OneTrust

Senior Director, Regulatory Compliance, Large Molecule

OneTrust

full-time

Posted on:

Location Type: Office

Location: Horsham • New Jersey • Pennsylvania • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $178,000 - $307,050 per year

Job Level

Senior

About the role

  • Define and lead a global GMP compliance strategy for Large Molecule biologics that aligns with IM Compliance objectives and business priorities.
  • Translate strategy into an annual compliance roadmap with measurable milestones, resource plans and KPIs tied to inspection readiness.
  • Oversee compliance across all stages of the biologic’s lifecycle, from production to storage and distribution.
  • Ensure that suitable GMP controls are implemented for each type of system.
  • Maintain continuous inspection readiness across internal manufacturing sites, CMOs, analytical labs and key suppliers; lead inspection planning, mock inspections, readiness assessments, cross-functional briefings and response coordination.
  • Act as primary or co-lead for interactions with health authorities (e.g., US FDA, EMA, MHRA, PMDA), including drafting inspection responses, preparing submission-related GMP evidence and negotiating remediation plans.
  • Design and direct a risk-based audit program covering manufacturing sites; oversee audit scope, execution, findings resolution, CAPA effectiveness verification and trending.
  • Lead risk identification, assessment and mitigation across biologics manufacturing and support functions; prioritize remediation to reduce patient and regulatory risk while maintaining supply.
  • Provide compliance input for regulatory filings, pre-submission meetings and responses to agency questions relative to GMP/CMC readiness and inspection history.
  • Build and lead a high-performing Large Molecule compliance team; define competency frameworks and deliver targeted GMP training for manufacturing, analytical and supplier organizations to raise compliance maturity.
  • Promote a culture of quality-first decision making, transparent escalation and continuous improvement across the platform.
  • Drive continuous improvement initiatives to reduce repeat findings, enhance process robustness and shorten time-to-release while be compliant with regulatory expectations.

Requirements

  • Bachelor of Science degree preferred; advanced degree (MS, PhD) desirable.
  • Experience providing remediation support for organizations facing FDA Warning Letters or Consent Decrees preferred.
  • Background working with agencies such as the US FDA, EMA or MHRA in the context of biologics manufacturing.
  • Hands-on operational knowledge of cell banks, upstream cell culture, downstream purification, analytical labs and CMOs for biologics.
  • Experience as an Investigator for the US FDA is also acceptable.
  • Expertise in biologics modalities, viral clearance/inactivation strategies, potency/assay strategy, stability and comparability assessments.
  • Demonstrated success implementing inspection readiness, audit programs and vendor oversight for large molecule products.
  • Proven experience collaborating with, or working for, regulatory agencies or health authorities such as the US FDA or MHRA.
  • A proven record of leading both direct and indirect teams to accomplish objectives and deliver results.
  • Ability to balance technical knowledge of products and processes with a compliance-driven perspective and sound business judgment.
  • Candidates must have a minimum of 10 years of experience managing people, including building and developing technical compliance teams.
Benefits
  • Vacation – 120 hours per calendar year
  • Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays – 13 days per calendar year
  • Work, Personal and Family Time – up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period10 days
  • Volunteer Leave – 32 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
GMP compliancebiologics manufacturingrisk-based auditinspection readinessremediation plansviral clearance strategiespotency assay strategystability assessmentscomparability assessmentsCAPA effectiveness verification
Soft skills
leadershipcollaborationdecision makingcommunicationteam buildingproblem solvingstrategic planningcontinuous improvementorganizational skillscross-functional coordination
Certifications
Bachelor of ScienceMaster of SciencePhD