Global Quality and Compliance Director

3 days ago

London, United Kingdom CV-Library Full time

Global Quality and Compliance Director - UK REMOTE - to £100k plus package.


We are seeking an experienced Quality Assurance and Compliance Director with a background in the Life Sciences / Pharmaceutical sector and a strong understanding of GMP regulations. You will manage a large Pharmaceutical account globally, requiring confidence, diplomacy, and the ability to foster positive relationships. This role involves developing solutions to comply with GMP and includes travel with excellent career progression opportunities.


Job Purpose

The Global Quality Compliance Lead is part of the Pharma Quality & Compliance Group and is responsible for overseeing Quality and Compliance globally across the CLIENT, covering both Human Health and Animal Health divisions. This high-profile role provides exposure to senior management and unique opportunities for career advancement.

The Pharma Quality & Compliance group supports regional QC teams dedicated to specific contracts/clients, conducting audits, regulatory intelligence, and managing the global Quality Management System for the Pharma business.


Accountabilities – Client Focused
  1. Manage quality and compliance activities and oversee GxP compliance aspects globally.
  2. Perform audits of all GxP services provided to the CLIENT.
  3. Work with CLIENT teams to investigate root causes and implement corrective actions for GxP deficiencies.
  4. Influence and coach senior management to ensure robust quality systems are in place.
  5. Present quality topics to senior management through governance meetings.
  6. Develop strong relationships and maintain communication with key CLIENT personnel.
  7. Provide oversight to global Quality and Compliance staff on the account.
  8. Conduct site visits to implement quality systems and ensure compliance with regulatory expectations.
  9. Advise CLIENT of any legislative changes impacting the business.
  10. Conduct training in GxP and QMS topics for operations and management teams.
  11. Support operational performance management related to quality and GxP KPI targets.
  12. Ensure oversight of vendor-delivered GxP services.
  13. Execute processes in compliance with relevant standards (e.g., QMS/documentation control, risk management).
  14. Work across the global portfolio as part of the CLIENT senior leadership team.

Accountabilities – Above Account Focused
  1. Serve as a member of the Quality Assurance Leadership Team (QALT).
  2. Execute special audits as required by senior executives.
  3. Assist with the development and improvement of the Global Quality Management System.
  4. Perform investigations and special projects as required.
  5. Support business development teams in securing new business.

Key Performance Indicators (KPIs)
  1. Successful CLIENT and regulatory audits of GxP activities.
  2. Timely reporting and investigation of GxP quality incidents.
  3. Added value through efficient, standardized systems.
  4. Good team player in an international environment.
  5. Flexibility to perform ad hoc assignments.
  6. Continuous development of technical and business skills.

Skills, Knowledge, and ExperienceEssential
  1. Solid grounding and practical experience in a pharmaceutical environment, particularly in Quality functions.
  2. In-depth knowledge of GxP regulations and standards.
  3. Substantial auditing background.
  4. Ability to write effective reports and communications.
  5. Strong analytical skills.
  6. Ability to apply Quality Risk Management principles.
  7. Excellent communication skills, recognizing cultural values.
  8. Fluent in English; other languages are an advantage.
  9. Minimum 5 years' GXP Pharmaceutical Quality experience in senior roles.
  10. Extensive knowledge of current market conditions.

Desirable
  1. Clear thinker with determination and energy.
  2. Assertive yet personable.
  3. Excellent communication and interpersonal skills.
  4. Influential leader, able to work independently.
  5. Strong attention to detail.
  6. Able to work under pressure and manage change.
  7. Committed to self-development and continuous improvement.
  8. Commercial judgment and project management experience.

Competencies (Operational & Core)
  1. Growth, Client and Customer Satisfaction.
  2. Rigorous management of results.
  3. Brand notoriety.
  4. Analysis & decision making.
  5. Leadership & people management.
  6. Innovation & Change.
  7. Industry acumen.
  8. Planning & organization.

Job Info

Job Title: Global Quality and Compliance Director

Company: CV-Library

Location: UK REMOTE

Posted: [Insert Date]

Closes: Jan 10th 2025

Sector: Medical, Pharmaceutical & Scientific

Contract: Permanent

Hours: Full Time

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