Quality Inspection Readiness Director

GSK; Parma; Ibrido; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading biopharma company in Italy is seeking a Quality Inspection Readiness Director to ensure regulatory compliance and maintain inspection readiness across various sites. The role involves supporting sites in preparing for inspections, offering expert guidance, and driving continuous improvement in quality processes. Candidates should have a bachelor’s degree and over 10 years of experience in regulatory compliance, ideally within biotech or pharmaceuticals. This hybrid role also requires occasional travel.

Servizi

Potential annual bonus

Comprehensive benefits package

Health care

Retirement plans

Competenze

• 10+ years of experience in quality assurance or regulatory compliance.
• Knowledge of global cGMPs and regulatory requirements.
• Experience in handling regulatory inspections.

Mansioni

• Support sites to be inspection ready through various activities.
• Prepare for, conduct and manage inspection readiness activities.
• Provide coaching and support during key regulatory inspections.
• Develop and maintain tools to support the inspection readiness process.

Conoscenze

Quality assurance

Regulatory compliance

Risk management

Continuous improvement

Formazione

Bachelor’s degree

Descrizione del lavoro

Overview

Join to apply for the Quality Inspection Readiness Director role at GSK.

Site locations include USA - Maryland - Rockville, GSK HQ, Marietta PA, Parma, UK - Hertfordshire - Ware, Upper Merion, Upper Providence, Zebulon. Posted date: Oct 15 2025.

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We are seeking the very best minds and capability to help us harness smart manufacturing technologies, including robotics, digital solutions and artificial intelligence, to deliver for patients.

Are you ready to make a meaningful impact in ensuring regulatory compliance and inspection readiness across a global organization? As a Quality Inspection Readiness Director, you will help sites meet regulatory standards and maintain inspection readiness daily, collaborating with cross-functional teams, providing expert guidance, and driving continuous improvement in compliance processes.

Responsibilities

• Support GSK sites/related functions that are inspected by key regulators (FDA, MHRA, EMA outside of Europe, HPRA and China) to be inspection ready through inspection readiness activities (pre-, during, and post-inspection).
• Pre-Inspection – Prepare for, conduct and manage inspection readiness activities and site assessments using a risk-based approach.
• Prepare clear and objective assessment reports communicating inspection readiness risks to senior management and ensuring corrective action plans are implemented.
• During Inspection – Provide SME coaching, Control Room and Inspection Room support for key regulatory inspections.
• Post Inspection – Review regulatory responses as part of the central review team, perform Global Assessments and participate in After Action Reviews; initiate multi-site commitments if there is a wider GSK impact.
• Act as a business partner to enhance GSK’s risk management and share best practices and improvement opportunities.
• Support site capability building through training and coaching of site SMEs in preparation for GMP regulatory inspections.
• Review and check CAPAs for key regulatory inspections before the next site inspection to ensure closure effectiveness.
• Attend internal GMP/GDP forums and provide recommendations for continued compliance and the use of new technologies in processes.
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies.

Additional Activities

• Be the point of contact with sites being assessed for inspection readiness.
• Propose updates to Global QMS documents and/or local site SOPs based on identified gaps.
• Assist in training and coaching of guest assessors.
• Promote excellence and continuous improvement in inspection readiness, best practices, and processes.
• Work with the QMS team on policies and processes related to Inspection Readiness.
• Participation in IR CoP/Compliance Forum and share learnings from significant regulatory inspections across GSK as appropriate.
• Develop and maintain tools to support the inspection readiness process; ensure suitable KPIs are in place to support decision-making.

Qualifications

• Basic Qualifications: Bachelor’s degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.
• Preferred Qualifications: Knowledge of global cGMPs and regulatory requirements; experience in regulatory inspections, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, or sterile products; ability to identify regulatory inspection risks; expertise in one or more pharmaceutical dose forms or technologies; familiarity with primary/secondary manufacturing and biopharmaceuticals; knowledge of risk management, governance processes, incident management, and process improvement related to inspection readiness.

This role is hybrid, but requires proximity to a GSK site and may require travel up to 50%.

Salary information for the US is provided as a range and may vary by location, skills, and experience. This position includes potential annual bonus and long-term incentive eligibility, with comprehensive benefits including health care, retirement, holidays, vacation, and parental/medical leave. Visit the GSK US Benefits Summary for details.

Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company focused on four therapeutic areas: respiratory, immunology and inflammation, oncology, HIV, and infectious diseases. We strive to create an environment where people can thrive and focus on delivering for patients, shareholders and colleagues. If you require an accommodation or other assistance to apply, contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or [phone] (outside US).

GSK is an Equal Opportunity Employer. This ensures all qualified applicants receive equal consideration, regardless of race, color, religion, sex, pregnancy status, gender identity, sexual orientation, parental status, national origin, age, disability, or genetic information.