Manager, Operational Quality - VCGT 897 (Contract)

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.

• →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.

• 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.