Senior Quality Manager, GDP Operational Quality, 12 month FTC - London, United Kingdom - Vertex Pharmaceuticals

Description

Senior Quality Manager, GDP Operational Quality, 12 month FTC page is loaded

Senior Quality Manager, GDP Operational Quality, 12 month FTC

Job Description

General position summary:

The Senior Quality Manager is responsible for t he p rin c ip l e s a nd a ppl i ca t i on of qu a l i t y a n d GDP re g ulato r y c omp l ia n ce . The Quality Manager will support the development of global processes for distribution of Vertex's materials, intermediates, and finished medicinal products (commercial and clinical) across its global distribution network.

This role supports GDP operations for all distribution activities within the global distribution network; key stakeholders include Operations QA, International Supply chain, demand planning, logistics, Geographic expansion, QMS/OMS QA, Vendor Management & AIM QA.

Key Responsibilities:

The responsibilities of this position will include, but are not limited to, the following:

• Responsible in the Quality Processes/Process Ownership for the distribution of Commercial & Clinical material movement. These processes will cover controls and oversight at Vertex office operations, third party logistics providers, distribution partners, unlicensed medicines supply, wholesalers and carriers.
• Proactively manage an effective global shipping qualification process.
• Participate in inspection preparation and management, prior to, during and following any Competent Authority inspection of international locations; Support manufacturing locations as required
• Participate the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.
• Participate in Geographic Expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Wholesale Dealers Authorization (or equivalent) application, audits, and Quality Agreements.
• Support recalls, mock recalls and any other in-market activity.
• Support in New Product Launch activities to assess new territories distribution requirements and expectations.
• Serve as QA assessor on Change Controls: resolve gaps and identify strategy for GDP/GMP actions.
• Have a strong knowledge of GDP regulations and requirements.
• Day to day oversight of Distribution Partners, including:
  • Preparation and maintenance of Quality Agreements
  • Review of deviations, CAPA and changes identified
  • Maintaining KPIs
  • Escalation of issues
• Support late stage customization operations performed on behalf of, or by a commercial partner

Experience, Skills and Qualifications:

• Bachelor's degree in a scientific or allied health field (or equivalent degree) and relevant work experience, or relevant comparable background
• Knowledge of International GDP regulations; GMP and GVP regulations
• Previous GDP auditing experience, GMP experience preferable.
• Ability to learn new information and roll out to the wider audience to develop their knowledge.
• Strong leadership skills with the ability to thrive in a high throughput environment.
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Ability to collaborate cross functionally across all levels of the organization
• Ability to design, develop and deliver effective training
• Ability to drive results
• Adaptability /Flexibility
• Analytical thinking / Data Analysis/ Attention to detail
• Change Management
• Continuous Process improvement
• Critical thinking / Problem solving / decision making
• Project Management- time and resource management and prioritization, planning and organization skills
• Relationship Management skills- communication, influence, conflict management, ability to understand and translate customer needs
• Strategic thinking / forward thinking / planning
• Technical writing
• Expert knowledge of global GDP/GMP requirements governing oral drug products and knowledge of product manufacturing practices

This is a hybrid role where you will be expected to be onsite 3 days per week and work from home 2 days per week.

You will also be required to travel up to 20% of the time

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at

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Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook , Twitter/X , LinkedIn , YouTube and Instagram .

The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.

Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.