Manager , Operational Quality, External Manufacturing; VCGT

Job Description

The Operational Quality Assurance Area Manager will provide QA support for manufacturing and analytical laboratory operations for external manufacturing programs s role will review batch data, including batch records, deviations, in-process data, EM data, QC release and stability testing and other quality systems documentation as needed in support of product disposition.

• Reviews master batch records and provide customer approval for quality tasks for externally manufactured products
• Reviews analytical laboratory testing data including method validation, QC testing and CoA issuance with providing customer approval for externally manufactured products
• Performs final review of executed batch and/or critical systems documentation including certificate of analysis / certificate of conformance and determines acceptability by using standard operating procedure
• Ensures presence and acceptability of all required documentation prior to the release of the product and/or system
• Assists with analytical investigations, deviations, and change controls for external programs
• Supports the day-to-day management of the batch release process
• Communicates proactively with internal and external partners and management
• Assists in the maintenance and archival of document management such that documents are readily available and easily retrievable
• Assists with metrics and data reporting pertaining to program reporting
• Escalates critical and major findings to Quality management
• Collaborate with external vendors supporting the review of external GMP documentation for product disposition

• Bachelor’s degree in a scientific or allied health field with 5-7 years of relevant work experience, or relevant comparable background
• Knowledge of cGMP's in a pharmaceutical setting
• Experience providing QA support and oversight of GMP manufacturing and GMP laboratory operations with external vendors
• Experience working with external vendors on reviewing external GMP documentation
• Experience successfully leading event investigations, deviations and change controls
• Experience with network-based applications such as Veeva, LIMS and Oracle
• Strong attention to detail
• Effective communication skills, both verbal and written
• Ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects

$70-75/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.

The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

No C2C or Third-Party Vendors