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Job #03537

About our client Our client is a publicly traded biotechnological company headquartered in the United Kingdom which focuses on the development of treatments for cancer. The organization has an experienced management team, a robust pipeline of development products, a world-class corporate culture and an established reputation for being a leading innovator in the field. Position Location Director of Quality Assurance Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) This role is to provide quality leadership and expertise in the US and to contribute to the overall GMP/GLP/GDP quality management, and to be responsible for compliance with the requirements of the FDA and other regulatory authorities. 2) The job holder will also be expected to provide leadership and operational excellence to enable the quality function in the company to work effectively in a commercial environment by 2011. The company intends to have an MHRA license for release of IMPs in Europe, and the Pharmaceutical Quality Director needs to have the expertise to release IMPs to US and rest of world. 3) Member of Quality Strategy Group. The QSG defines and implements the quality strategy for the company across all GXPs. This group reports to the CEO via the Senior Management Team. 4) Work within Quality Strategy Group to ensure seamless processes across the GMP/GCP/Regulatory interfaces to maximize the quality and effectiveness and overall value of the quality operations. 5) Work with the Head of Pharmaceutical Quality Assurance to develop the quality strategy for the organization from the GMP/GLP/GDP perspective, and contribution to overall corporate quality management to ensure resources are allocated on a risk based approach. 6) Vigilance on conformance with new GMP/GLP/GDP guidance from FDA and rest of world regulatory authorities. 7) Lead preparations for and participate in Regulatory Authority inspections, as appropriate to project or geographical need. 8) Act as the QA representative on project teams as required. 9) Involvement in commercial activities as required. This could include contribution to meetings with partners or due diligence exercises. 10) Develop an effective working relationship with all team members, and external contractors. 11) Batch review and release - Perform batch record reviews and determine batch disposition for API, bulk IMP and Clinical IMP. Liaise with contractors to resolve any issues to ensure batch release activities can be completed as scheduled. 12) Report review - Perform the QA review of externally and internally generated reports/documents as necessary to support batch release activities and regulatory submissions. 13) Working with Head of Pharmaceutical QA to ensure effective operation of all aspects of the QMS, including: i) GMP Incidents - Review contractor generated deviations. Write deviations. Assign the final deviation category and approve as appropriate. ii) CAPA - Assign CAPA actions and approve as appropriate. iii) Change control - Review and approve change controls as required. iv) KPI trends - determine appropriate KPIs and prepare periodic reports for review by Senior Management. v) SOPs - Ensure that the SOPs reflect the current practices and are in agreement with the regulatory requirements. vi) Training - Help develop and maintain GMP training plans, providing the training and monitoring the training for effectiveness via the Quality Strategy Group. vii) Audits - Help develop the overall quality audit plan. Perform internal and external GMP audits either alone or as part of an audit team, depending on the nature of the audit. Prepare audit objectives/plans and audit reports and ensure timely follow up of all observations to a satisfactory conclusion. viii) KPIs - Work with quality team to determine KPI trends and prepare periodic reports for review by Senior Management. Requirements 1) A relevant degree (or equivalent). 2) Significant relevant experience of operating a quality function and determining batch disposition within a virtual or semi virtual environment. 3) Significant relevant experience manufacturing of small molecule APIs. 4) Proven GMP auditing experience for API and IMP and packaging contractors. 5) Experience of working in a commercial environment. 6) Ability to travel in US, Europe and Rest of World.