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Alliance Inspection Management
Alliance Inspection Management

60 Alliance Inspection Management Jobs Hiring Near You

Alliance RV

PDI Inspector

Elkhart, IN · On-site

Alliance RV Job Openings >> PDI Inspector PDI Inspector Summary Title: PDI Inspector ID: 10175 ... Quality Manager Position Summary: The PDI (Pre-Delivery Inspection) Inspector is responsible for ...

BeiGene USA

Director, PV Alliance Management

The Director, PV Alliance Management leads the global team of PV Alliance Management and is ... Serves as subject matter expert for audits and inspections of the GPS pharmacovigilance system.

Alliance RV

PDI Inspector

Elkhart, IN · On-site

Quality Manager Position Summary: The PDI (Pre-Delivery Inspection) Inspector is responsible for ... Alliance RV, LLC is an Equal Employment Opportunity / Affirmative Action Employer

Alliance Consulting, Inc.

Be Seen First

Environmental Technician/Inspector

Canonsburg, PA · On-site

Monitoring and inspection tasks generally include: * Stream monitoring for flow volumes, flow ... Vegetation Surveys and Vegetation Management for long-term restoration and mitigation sites;

Alliance Consulting, Inc.

Be Seen First

Environmental Technician/Inspector

Canonsburg, PA · On-site

Monitoring and inspection tasks generally include: * Stream monitoring for flow volumes, flow ... Vegetation Surveys and Vegetation Management for long-term restoration and mitigation sites;

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All JobsAlliance Inspection Management Jobs

Senior Manager, Clinical and PV Quality Assurance (Inspection Readiness and Management)

Los Angeles, CA • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

$145K - $170K/yr

Other

Posted 16 days ago

Job description

The Position

Provide strategic leadership for the company’s global Clinical and Pharmacovigilance (GCP/GVP) Quality Assurance programs, including inspection readiness, regulatory inspection management, internal quality audits, and partner audit activities. Lead the Inspection Readiness and Management Program as the primary Inspection Lead for FDA (BIMO), MHRA, PMDA, EMA, and other global Health Authority inspections (including PV post-marketing inspections). Lead and execute a risk-based internal GCP/GVP audit program and oversee partner/alliance audits to evaluate compliance with regulations, industry standards, and company procedures.

Responsibilities
  • Own the global GCP/GVP Inspection Readiness Program and establish governance for continuous readiness.
  • Serve as primary Inspection Lead and Host for health authority inspections (including PV post-marketing surveillance).
  • Lead inspection planning (scope, logistics, agendas, virtual platforms, document management, communications).
  • Facilitate inspection management before/during/after inspections; chair daily meetings and debriefs.
  • Prepare SMEs/executives via mock inspections, interview coaching, simulations, and readiness assessments.
  • Oversee regulatory document requests, submission quality reviews, and response consistency.
  • Lead responses to Form FDA 483/equivalent findings, CAPAs, effectiveness checks, and regulatory commitments.
  • Provide oversight of CROs/vendors/business partners to ensure inspection support.
  • Develop and present inspection readiness dashboards, KPIs, and risk/trend analyses.
  • Implement new global regulatory expectations (ICH E6(R3), FDA, EMA, MHRA, PMDA, GVP).
  • Drive continuous improvement initiatives for inspection readiness and quality systems.
  • Develop and lead risk-based GCP/GVP internal audits, including CAPA oversight.
  • Lead/host partner, alliance, licensing, and due diligence audits.
Location

Pasadena; expectation to be in office 5 days/week.

Requirements
  • Bachelor’s degree in life sciences, pharmacy, chemistry, or related.
  • 8+ years regulated pharma/biotech experience; 5+ years in leadership with increasing responsibility.
  • Full knowledge of GxP (including GCP/GVP), ICH, and ISO standards.
  • Project management, organization/execution, and priority-setting skills.
  • Strategic, continuous-improvement mindset; ability to anticipate/resolve problems.
  • Excellent communication/interpersonal/leadership skills; influence stakeholders.
  • Experience with EMDS/EQMS.
  • Business travel ~25–30%.
Preferred
  • Advanced degree in life science.
Compensation

California pay range: $145,000–$170,000 USD.

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