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Job Description

General Summary:

The GDP Operational Quality Senior Manager will develop global processes to support distribution of Vertex’s commercial products across its global distribution network.

This role supports GDP operations for distribution activities globally; key stakeholders include Operations QA, International Supply chain, demand planning, logistics, Geographic expansion, QA, Vendor Management & AIM QA.

Key Duties and Responsibilities:

• Establish robust Quality Processes/Process Ownership for the distribution of Commercial Finished Goods across our Distributor Markets
• Define a process outlining requirements for only using qualified vendors for distribution in Distributor Markets
• Support Inspection preparation and management, prior to, during and following any Competent Authority inspection of international locations; Support manufacturing locations as required
• Support 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, audits, and Quality Agreements.
• Support recalls, mock recalls and any other on-market activity as required
• Support in New Product Launch activities to assess new territories distribution requirements and expectations.
• Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.

Knowledge and Skills:

• Expert knowledge of global GDP/GMP requirements governing oral drug products and knowledge of product manufacturing practices
• Knowledge of International GDP regulations
• Previous GDP auditing experience
• 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
• Analytical thinking / Data Analysis/ Attention to detail
• Change Management
• Critical thinking / Problem solving / decision making
• Skilled at time and resource management and prioritization, planning and organization skills
• Ability to communicate, influence, conflict management, ability to understand and translate customer needs

Education and Experience:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree)
• Requires relevant work experience, or the equivalent combination of education and experience

#LI-SM2

#LI-Hybrid

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

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