Head of Quality and Pharmacovigilance Compliance

Nobelpharma America, LLC

Head of Quality and Pharmacovigilance Compliance providing compliance oversight for U.S. operations.

Posted 4/28/2026full-timeBethesda • Maryland • 🇺🇸 United StatesLead💰 $180,000 - $240,000 per yearWebsite

About the role

Key responsibilities & impact

Serve as the accountable owner of the U.S. compliance framework, ensuring that compliance risks across regulatory domains are identified, documented, monitored, and appropriately mitigated.
Maintain a consolidated, enterprise-level view of compliance status, risks, and mitigation progress across U.S. regulatory areas, including but not limited to Medical Information / OPDP, DSCSA, and state-level compliance.
Act as a key advisor to the CEO and executive leadership by providing clear visibility into compliance risk exposure, trends, and inspection readiness.
Prepare and present regular updates to executive management on material compliance matters, risk assessments, and remediation activities.
Review and provide formal approval of compliance- and regulation-related documents to confirm they are complete, accurate, and aligned with applicable regulatory requirements and internal SOPs.
Provide formal readiness confirmation for documents requiring executive signature, while ultimate legal responsibility remains with company officers.
Coordinate with functional owners and external consultants to ensure accountability and timely remediation, without performing hands-on execution of operational tasks.
Oversee adherence to Quality Assurance SOPs and quality processes outside of Pharmacovigilance, acting as the internal counterpart to external Quality Assurance consultants.
Monitor compliance metrics, review audit findings and reports, and identify gaps or deviations from established quality standards.
Require corrective actions where deficiencies are identified, confirm ownership and timelines with functional leaders, and escalate unresolved issues as necessary.
Ensure that quality governance, documentation, and reporting practices are applied consistently across functions.
Serve as the formal owner of the U.S. Pharmacovigilance Quality System, including governance of PV SOPs, deviations, CAPAs, training, and documentation readiness.
Drive adherence to PV SOPs by internal teams and external vendors through oversight, guidance, and monitoring, while execution remains with responsible functions.
Lead and coordinate FDA inspections, regulatory interactions, and internal audits related to Pharmacovigilance quality.
Oversee PV vendors and adverse event and complaint case processing, including case quality, triage, and regulatory submission readiness.
Review key safety deliverables (e.g., PADERs, DSURs) to confirm quality, completeness, and regulatory compliance.
Maintain ongoing inspection readiness through periodic reviews of PV processes, records, training, and vendor performance.
Oversee the design and effectiveness of U.S. quality and pharmacovigilance compliance training programs, including role-based training requirements.
Promote a strong compliance culture by providing guidance and support to functional leaders and employees.
Serve as a key escalation point for compliance questions, concerns, or potential issues.

Requirements

What you’ll need

6+ years of experience in Pharmacovigilance, PV Quality, or related Quality / Compliance roles within pharma or life sciences, including U.S. post-marketing PV
Strong understanding of PV Quality System governance, including SOP management, deviations, CAPAs, training oversight, and vendor compliance
Experience supporting FDA inspections or PV-related audits (preparation, response coordination, and follow-up)
Demonstrated ability to operate effectively in a lean organization, balancing governance responsibilities with pragmatic decision-making
Exposure to broader compliance or QA areas beyond PV (e.g., GXP, OPDP, DSCSA, state-level compliance)
Experience coordinating external vendors or consultants in a quality or compliance context
Interest in expanding scope from PV-focused leadership to enterprise-wide Compliance & QA oversight
Prior experience in small or mid-sized life sciences companies
Ability to communicate complex regulatory topics clearly to non-specialist audiences

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Nobelpharma America, LLC Website LinkedIn All Job Openings 11 - 50 employees Nobelpharma develops medicines and medical devices with a focus Head of Quality and Pharmacovigilance Compliance 🔥 1 hour ago 🏢🏡 Bethesda – Hybrid 💵 $180k - $240k / year ⏰ Full Time 🔴 Lead 🚔 Compliance Apply Now Find Hiring Managers Customize resume for this job Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Serve as the accountable owner of the U.S. compliance framework, ensuring that compliance risks across regulatory domains are identified, documented, monitored, and appropriately mitigated.
Maintain a consolidated, enterprise-level view of compliance status, risks, and mitigation progress across U.S. regulatory areas, including but not limited to Medical Information / OPDP, DSCSA, and state-level compliance.
Act as a key advisor to the CEO and executive leadership by providing clear visibility into compliance risk exposure, trends, and inspection readiness.
Prepare and present regular updates to executive management on material compliance matters, risk assessments, and remediation activities.
Review and provide formal approval of compliance- and regulation-related documents to confirm they are complete, accurate, and aligned with applicable regulatory requirements and internal SOPs.
Provide formal readiness confirmation for documents requiring executive signature, while ultimate legal responsibility remains with company officers.
Coordinate with functional owners and external consultants to ensure accountability and timely remediation, without performing hands-on execution of operational tasks.
Oversee adherence to Quality Assurance SOPs and quality processes outside of Pharmacovigilance, acting as the internal counterpart to external Quality Assurance consultants.
Monitor compliance metrics, review audit findings and reports, and identify gaps or deviations from established quality standards.
Require corrective actions where deficiencies are identified, confirm ownership and timelines with functional leaders, and escalate unresolved issues as necessary.
Ensure that quality governance, documentation, and reporting practices are applied consistently across functions.
Serve as the formal owner of the U.S. Pharmacovigilance Quality System, including governance of PV SOPs, deviations, CAPAs, training, and documentation readiness.
Drive adherence to PV SOPs by internal teams and external vendors through oversight, guidance, and monitoring, while execution remains with responsible functions.
Lead and coordinate FDA inspections, regulatory interactions, and internal audits related to Pharmacovigilance quality.
Oversee PV vendors and adverse event and complaint case processing, including case quality, triage, and regulatory submission readiness.
Review key safety deliverables (e.g., PADERs, DSURs) to confirm quality, completeness, and regulatory compliance.
Maintain ongoing inspection readiness through periodic reviews of PV processes, records, training, and vendor performance.
Oversee the design and effectiveness of U.S. quality and pharmacovigilance compliance training programs, including role-based training requirements.
Promote a strong compliance culture by providing guidance and support to functional leaders and employees.
Serve as a key escalation point for compliance questions, concerns, or potential issues. 🎯 Requirements
6+ years of experience in Pharmacovigilance, PV Quality, or related Quality / Compliance roles within pharma or life sciences, including U.S. post-marketing PV
Strong understanding of PV Quality System governance, including SOP management, deviations, CAPAs, training oversight, and vendor compliance
Experience supporting FDA inspections or PV-related audits (preparation, response coordination, and follow-up)
Demonstrated ability to operate effectively in a lean organization, balancing governance responsibilities with pragmatic decision-making
Exposure to broader compliance or QA areas beyond PV (e.g., GXP, OPDP, DSCSA, state-level compliance)
Experience coordinating external vendors or consultants in a quality or compliance context
Interest in expanding scope from PV-focused leadership to enterprise-wide Compliance & QA oversight
Prior experience in small or mid-sized life sciences companies
Ability to communicate complex regulatory topics clearly to non-specialist audiences Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

PharmacovigilanceQuality AssuranceSOP managementCAPAsregulatory complianceaudit preparationrisk assessmentcompliance metricsdocument readinessadverse event processing

Soft Skills

communicationleadershipdecision-makingguidancesupportcoordinationproblem-solvingvisibilityescalationcollaboration