QA Manager, GMP Operations and Release

Site Name: Singapore - Tuas Posted Date: Dec 12 2022 Purpose The purpose of the QA Manager (GMP Operations and Release) is to provide direction, guide and coach a team of QA professionals to ensure quality oversight on manufacturing operational activities and timely product release in compliance with cGMP and defined quality requirements. Key Responsibilities Area People Lead a team of quality professionals the QC teams to manage the following: Provide QA oversight to manufacturing operations and product batch release and complaint management QA oversight activities include establishing compliant and practical systems with stakeholders, provide QA consultation, reviewing and approving SOPs, GMP records and documents, change controls, deviations and CAPAs. Provide QA operations support in managing complaints and recall investigations including the associated SAP system and workflow. Review and approve periodic product review, periodic management review where applicable. Release of produced batches (e.g. media/buffer, intermediates and final bulk), including the associated SAP system and workflow. Review and approve quality-tag-outs to ensure systems are fit for GMP purpose Be the business owner of site complaint management, batch release and internal/external customer quality agreement systems. Keep up-to-date on the regulations/development concerning biopharmaceutical activities (relevant to area of responsibility) to provide support and guidance to the team and to ensure appropriate QA oversight in manufacturing operations Create a culture of openness, accountability and ownership. Lead and ensure continuous improvement in area of responsibilities Team management Ensure appropriate team resources and stafffing to perform required quality oversight on manufacturing operational activities. Plan and develop the training and development plan of the team, giving consideration to working knowledge and stakeholder management of the team of QA executives. Plan, empower, develop, coach team where required Address team conflicts and manage performance of the team Work across boundaries Ensure teamwork within/across departments and/or sites Ensure adequate support to other team/departments/sites when necessary Safety Ensure safety and security policies and practices are deployed and respected in the team. Ensure a safe working environment for the team. Encourage team to contribute to a safe working environment by initiating