Quality Manager Validation and Launch, Finished Goods Commercial - Hybrid
The Quality Manager,Validation & Launch FG Commercial, is an internal technical resource in the application of quality assurance and compliance principles to executes activities on multiple projects and takes a role in the design and execution of new projects.
The Quality Manager, FG Validation & Launch works with a high degree of independence on multiple complex primary & secondary packaging validations, serialization validations and commercial manufacturing efforts for new product launches and line extensions in various regions. They provide over sight of the development, implementation, and maintenance of relevant quality initiatives in support of their function and completes work in a resourceful, self-sufficient manner. They can assess risk and design alternative approaches to achieve desired outcomes. They can troubleshoot problems, coordinate, and execute activities in alignment with corporate goals and compliance with all regulatory requirements.
This role is expected to work closely with business partners and stakeholders to ensure Packaging and Labeling validation execution is successful and commercial launch supply is available in global markets.
Key Duties and Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
- Lead Quality Commercial Finished Goods process validation activities
- Support Commercial Finished Goods product launch activities
- Collaborate with key business partners to develop launch and validation strategies
- Develop relationships with strategic external partners in support of Vertex's expanding commercial portfolio and manages ongoing relationships
- Perform disposition activities for Finished Goods in support of Commercial Product, including:
- Master and Executed Batch Record review and resolution of comments/issues
- Evaluations of investigations/ OOS/ Change Controls to support Disposition Status
- Certificate of Analysis approval
- Status change in Oracle
- Archiving of batch documents in electronic document system
- Assist with Escalation and Material Review Board activities, when necessary
- Lead quality oversight of artwork review, approval, & implementation for Commercial Finished Goods
- Provide quality guidance for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
- Provide compliance guidance to Commercial project teams
- Serve as QA assessor/approver on Commercial Change Controls: resolve gaps, approve change plans, verify change classifications, provide strategy for GMP release and disposition strategy
- QP Relationship, including facilitation of QP Release of finished goods and QP Declaration requests
- Perform Quality assessments and approvals for Commercial Change Control, ensure engagement of correct assessors on change type and provide strategy for product disposition
- Support review/approval of Supply Chain maps to ensure accuracy of end to end supply chain
- Assist in creating, negotiating, and maintaining Quality Agreements.
- Assist with establishment of Quality Processes/Process Ownership Packaging /Labeling and QP Release of Finished Goods
- May serve as CAPA owner
- Identifies risks and communicates gaps to management
- Generates and maintains operational batch release metrics for launch activities
- Support deployment of the Quality Management System as GMP Representative
- Provide Audit/Inspection Support
EDUCATION AND EXPERIENCE:
Bachelor's degree in a scientific or allied health field (or equivalent degree) Typically requires 4 years of experience, or the equivalent combination of education and experience
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:
1. On-Site and work 5 days per week with ad hoc flexibility;
2. Hybrid and work remotely up to two days per week on regularly scheduled days; or select
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.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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 [Register to View]