Senior Quality Manager - International GDP

Location London, Greater London, England
Discipline: Quality Assurance, Regulatory Affairs
Job type: Permanent
Salary: £Salary: £60,000 - £70,000 Per annum + Generous benefits package inc. bonus, shares, travel allowance
Contact name: Katie Dunbar

Contact email: Katie.Dunbar@rbwconsulting.com
Contact phone: 01293584300
Job ref: 21368
Published: about 1 month ago
Expiry date: 30 July 2021

There is an opportunity to join a leading biopharma business as a Senior Quality Manager for an international team, based in London. With an international distribution network, my client is seeking an expert in the principles of quality and GDP regulatory compliance, who is comfortable developing GDP processes on a global scale, for the distribution of raw materials and medicinal products for commercial and clinical applications.

This role reports to the Associate Director of GDP Operational QA, and collaborates with a range of internal key stakeholders including: Operations and QMS QA, International Supply Chain, Demand Planning, Logistics, Geographic Expansion, and Vendor Management teams.

Overview of Responsibilities:

  • Establish robust Quality Processes/Process Ownership for the distribution of raw materials and intermediates, and Commercial & Clinical finished goods

  • Develop and manage an effective global shipping qualification process

  • Support inspection preparation and management for competent authority inspection of international locations

  • Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.

  • Support recalls, mock recalls and any other on-market activity

  • Support the GDP management review process; review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps, and recommend mitigation approaches

  • Participate in geographic expansion activities to ensure that quality related actions are planned into projects

  • Support in New Product Launch activities to assess new territories’ distribution requirements and expectations

  • Day to day oversight of distribution partners

Essential Requirements:

  • Master’s degree or bachelor’s degree in a scientific discipline and relevant work experience

  • Knowledge of International GDP regulations; GMP and GVP regulations governing oral drug products and knowledge of product manufacturing practices

  • Previous GDP auditing experience with GMP experience

  • Able to work flexible from London office, WFH and to travel up to 30% of the time globally after Covid-19

  • Work cross functionally with all levels to foster exceptional collaboration and drive breakthrough results in a high throughput environment

  • Ability to evaluate quality matters and make decisions utilizing risk-based approach

  • Change Management and Continuous Process improvement

  • Ability to design technical documentation required for the role

Personal Profile;

  • High attention to detail, analytical thinking, and data analysis

  • Swift critical thinking, problem solving and decision-making ability

  • Ability to manage time and resources to prioritise, plan and organise

  • Excellent relationship management skills- can communication, influence, understand and translate customer needs

  • Strategic thinking / forward thinking / planning

My client are a well-respected business, and this role sits within a high performing team, offering room to develop and learn new skills. The remuneration and benefits package is highly competitive in the current market. If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.

Salary: £60,000 - £70,000 Per annum + Generous benefits package inc. bonus, shares, travel allowance