Manager, Operational Quality - VCGT 897 (Contract)

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 90,000 - 103,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston, MA is seeking an Operational Quality Manager to provide QA oversight for GMP manufacturing and testing operations, reviewing batch records, deviations, in-process data, and product disposition decisions.

The role requires a Bachelor’s degree in a scientific field and 5–7 years of relevant experience, plus knowledge of cGMP and experience with Veeva, LIMS and Oracle to support investigations and change controls.

Qualifications

• Bachelor’s degree in a scientific or allied health field; 5–7 years of relevant experience or equivalent mix of education and experience.
• Knowledge of current Good Manufacturing Practices (cGMP) in a pharmaceutical environment.
• Experience providing QA oversight for GMP manufacturing and testing operations.

Responsibilities

• Review master batch records and approve quality tasks for manufactured products.
• Review in-process, environmental monitoring, and QC data including certificates of analysis and provide required quality approvals.
• Perform final review of executed batch records and critical systems documentation for conformance.
• Confirm all required documentation is complete before product or system release.
• Support investigations, deviations, and change controls within manufacturing operations.
• Support day-to-day management of the batch release process.
• Communicate with internal and external partners and management.
• Maintain and archive records for retrievability.
• Prepare metrics and data for program reporting.
• Escalate critical and major findings to Quality management.
• Collaborate with external vendors to review GMP documentation supporting product disposition.

Skills

QA oversight

GMP knowledge

cGMP compliance

Documentation review

Investigations

Change controls

Data analysis

Communication

Prioritization

Vendor collaboration

Education

Bachelor's degree in scientific or allied health field

Tools

Veeva

LIMS

Oracle

Job description

Job Description

The Operational Quality Manager provides QA oversight for GMP manufacturing and testing operations. The role reviews batch records, deviations, in-process and environmental monitoring data, QC release and stability testing, and related quality documentation to support product disposition.

Key Responsibilities

• Review master batch records and approve quality tasks for manufactured products.
• Review in-process, environmental monitoring, and QC data, including certificates of analysis, and provide required quality approvals.
• Perform final review of executed batch records and critical systems documentation, including certificates of analysis and conformance, in accordance with procedures.
• Confirm all required documentation is complete and acceptable before product or system release.
• Support investigations, deviations, and change controls within manufacturing operations.
• Support day-to-day management of the batch release process.
• Communicate proactively with internal and external partners and management.
• Maintain and archive records so documents are readily available and retrievable.
• Prepare metrics and data for program reporting.
• Escalate critical and major findings to Quality management.
• Collaborate with external vendors to review GMP documentation supporting product disposition.

Qualifications

• Bachelor’s degree in a scientific or allied health field and 5–7 years of relevant experience, or an equivalent combination of education and experience.
• Knowledge of current Good Manufacturing Practices (cGMP) in a pharmaceutical environment.
• Experience providing QA oversight for GMP manufacturing and testing operations.
• Experience reviewing GMP documentation from external vendors.
• Experience leading investigations, deviations, and change controls.
• Experience with systems such as Veeva, LIMS and Oracle.
• Strong attention to detail and effective written and verbal communication skills.
• Ability to manage competing priorities and timelines in a fast-paced environment.

Contract Length: 12 months

Pay Range

$65/hr.-$75/hr.

Shift/Hours

Monday–Friday, onsite.

Requisition Disclaimer

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