QA Lead DS/DP Manufacturing
Our client, a global vaccine development and manufacturer, is currently recruiting a QA Lead Drug Substance/Drug Product Manufacturing to join their team on a permanent basis. In this role, you will be responsible and accountable for ensuring that a GMP production quality system is in place, adhering to all regulatory, cGMP, and company requirements. You will ensure that all structures are in place to monitor, measure, and apply a successful program. You will be responsible for ensuring that all necessary plans and standards are achieved consistently, maintaining a high level of quality. Previous people management experience is required for this role. This is a 5-day per week on-site role.
Responsibilities
* Act as site QA responsible for on-site quality monitoring of DS/DP manufacturing and participate in GMP production activities, such as process transfer and validation.
* Closely monitor the construction quality of GMP production.
* Support CQV activities as necessary.
* Work with functional departments to create department SOPs and assure alignment with corporate policies.
* Audit quality documents of functional departments to assure data integrity and provide guidance from a QA perspective.
* Support site GMP readiness preparation activities, including internal self-inspection programs.
* Responsible for establishing the DS/DP QA team, including online support.
* Work closely with other teams to support all GMP production activities.
* Perform routine audits for the manufacturing area to assure GMP production compliance with all regulatory, market, EU, FDA, and company standards.
* Review and approve manufacturing-generated documents, including but not limited to qualification plans/reports, SOPs, batch records, IPC results, deviations, CAPA, change control, and QRM.
* Ensure accurate reporting of manufacturing-generated results and assure data integrity in daily activities.
* Manage a team of employees across QA for DS/DP, ensuring all associated performance management requirements are in place for each employee and relevant reviews are completed regularly.
* Ensure all relevant training is provided to employees who carry out DS/DP duties to ensure site SOPs are followed and accurate identification of deviations or any other quality issues.
* Liaise actively with cross-functional teams for the release of DS/DP, including preparation of all documentation necessary for QP release.
* Other quality activities as assigned by the supervisor.
* Delegate responsibilities to Sr. Specialist, QA for DS/DP.
Requirements
* Knowledge of legislative, regulatory, market, biologics, and data integrity requirements.
* Preferable to have a qualification degree in Biopharmaceutical Science or another related science discipline.
* Relevant experience in vaccine/bio-pharma or similar experience in a pharma/science background.
* Strong communication skills with a demonstrated ability to work in a matrix environment.
* Strong leadership competencies with demonstrated 5+ years of management experience.
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