Address Job Description
General position summary:
The Senior Quality Manager is responsible for the principles and application of quality and GDP regulatory compliance. 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 ApplicationAssistance@vrtx.com.
