Description

Job Description

Responsible for the principles and application of quality and GDP regulatory compliance supporting the global processes for distribution of Vertex materials, intermediates, and finished medicinal products (commercial) across its global distribution network.

Stakeholders include GMP QA, Market Quality, Global Logistics, Vendor Management and AIM.

This position reports directly to: Associate Director/Director, Distribution Quality

Key Responsibilities:

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

• Distribution Quality subject matter expert providing technical and strategic direction to functional areas including Global Logistics on network and transport strategy projects, change controls, deviations, qualification and risk assessments.
• Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions and provide technical guidance specifically to functional areas including Global Logistics.
• Support the Quality Processes/Process Ownership for the distribution of product agnostic Commercial Finished Goods raw materials and intermediates. These processes will cover controls and oversight at Vertex office operations, GMP storage providers and transport providers.
  • Preparation and maintenance of Quality Agreements
  • Review of deviations, CAPA and changes identified.
  • Support the lifecycle management of distribution partners , vendor related plans, and ongoing gaps or risks for programs engaging with cross functional teams.
  • Attend Quarterly Business Reviews
  • Maintaining KPIs
  • Analyze, resolve, or assist in solving compliance and customer issues.
  • Escalation of issues

• Support the activities for Shipping qualification for Global Logistics for the new products:
  • Oversight of shipping qualification within Global Logistics

• Quality-related actions are planned into projects and completed in line with the commitments and that controls and oversight from Vertex are implemented
• Provide front and backroom inspection support and post-inspection follow-up with responses and CAPAs.
• Support DMQ in gathering relevant documentation for disposition on temperature excursions.
• Support the GDP Management Review process (metric review, regulatory intelligence, identification of risks and gaps)
• Manage/approve/assess event investigations (deviations)
• Manage CAPAs and effectiveness checks.
• Support recalls, mock recalls, and any other in-market activity.
• Serve as QA assessor on Change Controls: resolve gaps and identify strategy for GDP/GMP actions.

Qualifications/Knowledge/Skills:

• Bachelor's degree in a scientific or allied health field

• Strong knowledge of International GDP regulations; Good knowledge of GMP and GVP regulations,

• Good understanding of ICH Q9 and the ability to apply risk-based approaches to lead and development of efficient solutions that balance compliance and business requirements.

• Ability to proactively identify risk and develop mitigation strategies.

• Ability to collaborate cross functionally with good communication skills and the ability to influence others by leveraging active listening and delivering articulate and convincing ideas.

• Ability to align and adjust activities within one's scope of ownership to positively embrace change and support business growth and process improvements.

• Demonstrates ability to effectively communicate to one's team, local, international and global audiences, with integrity

• Ability to leverage critical and strategic thinking to determine and mitigate complex challenges and impact.
• Ability to apply business acumen, and leadership skills; across all relevant aspects of one's role; skilled at time and resource management,

Pay Range:
$0 - $0

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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