Cache of job #13255071

Job Title

Compliance/Quality Systems Director

Employer

Life Science Consultants Ltd

Location

Dublin

Description

Associate Director of Compliance and Quality Systems is required by a leading Biopharmaceutical start up in Dublin for an initial 10 month contract in a new state of the art large-scale biologics manufacturing facility. An exciting opportunity for a Quality Consultant/Professional to lead the development, implementation and lifecycle management of the Quality and Compliance Systems necessary to support construction, qualification and validation, technical transfers, regulatory approvals and ongoing commercial operations. The role will also support the existing global biologics labooratory through start up to PAI inspection readiness and into commercial finished product testing and release and assure integration of quality systems. As Associate Director of Compliance and Quality Systems you will be responsible for: Development and implementation of a robust quality system aligned with site quality system framework to support commercial bulk drug substance manufacture and release. Ensuring quality oversight of site compliance and quality systems activities including Quality Risk management, internal and supplier auditing, inspection management, records management, change control, and validation quality system approval. Hiring and managing resources to implement and manage the site's quality & compliance system and drive continuous improvement to ensure continuous quality of product to patient. Facilitating the development of GMP Training Curricula for both quality and non quality functions. Implementing and managing the Supplier Quality Agreements program to ensure that raw materials suppliers, services suppliers and equipment vendors meet applicable regulatory and company requirements. Developing/deploying Trackwise (Investigations and eCC) , DCA, GTS, SuccessFactors as well as user training module development and work instructions. This Associate Director of Quality will have: A degree in science, engineering or related discipline is essential. Prior experience and knowledge of biotech bulk and finished product manufacturing, analytical testing is essential. Minimum 15 years' experience in the biopharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, or a position within a Health Authority Agency. A minimum of 8 years management experience, and experience establishing, managing and improving commercial quality system programs is required. Qualified Person status as defined by the EU GMP requirements is a distinct advantage. Demonstrated proficiency communicating and collaborating at a variety of levels and across divisions. Proven success working well in a team environment with flexibility to react to changing business needs, as well as demonstrated problem solving and project management ability. For further information on this opportunity please contact Kathy at LSC on 021 4777329 or apply directly through this advert. This job originally appeared on RecruitIreland.com.

Date Added

2830 days ago

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