Description

Job Description

General position summary:

Responsible for the principles and application of quality and GDP regulatory compliance supporting GDP operations for distribution activities within the distribution network. Partnering with Supply Chain on all aspects of Supply Chain Compliance, Launch, Geo-expansion, SCM, QMS, CI/Change Controls and Vendor oversight.

Key stakeholders include Market Quality, Supply Chain Small Molecule and CGT, Operations QA, Demand Planning, Logistics, Quality Systems & Compliance QA, Vendor Management & Quality Compliance.

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

Key Responsibilities:

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

• Provide primary support to the Shipping, Storage and Distribution PON
• Act as the lead for named PON projects
• As a QA SME provide technical and strategic support to functional areas including other teams within Supply Chain for change controls, deviations, qualifications, and risk assessments.
• Lead and triage quality investigations (including Deviations, and complaints), ensuring they are fully documented, with appropriate root cause and corrective and preventative actions (CAPA) have been identified and addressed.
• Write and maintain Quality Agreements/CSOPs between transport partners and Vertex, as needed.
• Act as QA reviewer and approve Shipping, Storage and Distribution SOPs and WIs.
• Act as QA reviewer and approve International Supply Chain Maps as directed.
• Ensure GDP and quality compliance by identifying and implementing areas for continuous improvement utilising the SS&D PON
• Partner with Supply Chain on Continuous Improvement initiatives attending CI forums as necessary and ensure the associated Change Control record is maintained.
• Support the lifecycle management and governance of distribution partners engaging with cross functional teams.
• Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions.
• Support in New Product Launch activities to assess new territories distribution requirements and expectations, acting as a Functional Impact Assessor and Change Action owner where appropriate
• 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 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:

• Bachelors 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 deliver articulate and convincing ideas.
• Ability to align and adjust activities within ones scope of ownership to positively embrace change and support business growth and process improvements.
• Demonstrates ability to effectively communicate to ones 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

Flex Designation:
Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

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