Director Senior Director QA

This job has now expired please search on the home page to find live IT Jobs.

I am working with one of the world's Leading Biotechnology companies who is currently building Irelands largest scale bulk biologics production facility in Ireland. The Irish site is currently recruiting for a Senior Director/Director of QA operations.

An extremely competitive salary and benefits package in addition to relocation package is on offer.

The successful candidate will be responsible for the development and execution of the strategy and plan for the Industrial Operations and Product Supply (IOPS) quality function. The individual will also be responsible for providing direction to the functional area to ensure high-quality, safe and effective products that are compliant with global regulatory expectations. The incumbent will direct the quality efforts of the applicable functional area in support of the compliance and business objectives and will ensure that adequate talent and other resources are available to meet the challenges of the organization.

Essential Duties and Responsibilities include, but are not limited to, the following:

* Implement a value-added quality system based on sound science and the application of the appropriate quality, regulatory and legal requirements.

* Monitor the performance of the quality system using the appropriate metrics and demonstrate a commitment to continuous improvement.

* Embed quality tools and risk management processes with the quality system.

* Stay abreast of changing requirements/expectations and proactively address with the quality system.

* Use quality and risk management tools to make timely, science-based decisions to protect patient safety.

* Implement appropriate solutions that address complex technical, legal and global regulatory standards.

* Demonstrate confidence during difficult decision-making and influence internal and external business partners to ensure acceptable quality outcomes.

* Lead as quality and compliance decision maker to ensure the safety and effectiveness of the products.

* Represent as the face of IOPS quality and compliance to internal and external stakeholders, including regulatory agencies and corporate partners.

* Translate the vision and business strategies of the Quality organization into executable actions plans.

* Ensure the Quality Strategy is transparent and the organization is engaged in its execution.

* Allocate resources based on the quality system priorities and corresponding business needs.

* Establish high standards for performance management and accountability to achieve quality and organizational objectives.

* Attract, retain and proactively develop a pipeline of key talent through coaching, training, experience development and internal/external recruitment.

* Identify business-critical positions and establish robust succession planning strategies.

Education and Experience:

* BS or higher in Engineering, Chemistry, Biology or related science/technical field; MS in science/technical field / QP Qualification would be an advantage.

* Minimum of 15 years' experience in a pharmaceutical/biotechnology manufacturing environment (biotech preferred) with 5+ years prior experience in a managerial capacity.

* Prior experience with facility start-up, technology transfer, validation, Pre-Approval Inspections, and product launch activities is desired. Thorough knowledge of cGMPs and cGLPs; current knowledge and/or experience with QA systems such as change control, investigations (manufacturing / laboratory), deviations, CAPA, document management systems, etc.

* Comprehensive knowledge of quality expectations throughout drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, global regulations and guidelines, particularly CMC and GMP.

* Experience building up a quality culture and quality management capabilities. Specific knowledge of the core quality concepts (e.g. QRM, MRB), skills (e.g. product release, inspection readiness, quality engineering) and infrastructure (e.g. quality systems IT design and integration).

* Comprehensive knowledge and experience in CMC actions for investigational and marketed product submissions (IND, BLA, CBE, PSA) for FDA and equivalent (i.e. MAA, IMP, CTA/variations) submissions for Europe/Rest of World.

* A sense of passion and commitment for delivering things as quickly and efficiently as possible.

* Possesses the ability to think and operate in a rapidly evolving and ambiguous environment.

* Is able to articulate and execute concepts for developing and ensuring quality throughout the network.

* Has strong experience in quality risk identification, mitigation and management.

* Demonstrated experience accomplishing goals and delivering results through the management of a team.

* A change agent capable of recognizing mediocrity, defining required changes and delivering decisively.

* Strong communication skills - written and oral.

* Experience with businesses in different phases of the business lifestyle and the quality issues associated with these phases.

To hear more about the company and the role please contact me, for immediate consideration please apply with an up to date CV.