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May 23 2018

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Offer: Quality Director:RFT Group - Pharmaceutical Division.

Job description:

Quality Director

RFT Group - Pharmaceutical Division.

   » Westmeath
   » 100000 - or more
   » Permanent full-time
   » Updated 16/05/2018
   » Gerry Kennedy this job is expired SaveSave Apply Now

Job detail

Quality Director in sterile manufacturing

Quality Director
Our client is a young exciting biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research.
The Quality Director is accountable for the overall manufacturing plant quality assurance operations. The function includes QA and QC groups and reports directly to Corporate QA with a dotted line to the Ireland Site Director. The Quality Director is a key member of the Site leadership abilities Team responsible for developing the site culture, organization, systems, and operational readiness etc. The Quality Director will provide quality input and oversight of the validation and operation of the new Ireland manufacturing facility, including creation and implementation of the site quality management system and its interfaces with the corporate QMS. The new facility will manufacture, package and label the company's drug products. The Quality Director will be responsible for developing the Quality team for the site and will be responsible for ensuring that the site is validated, approved and licensed for manufacturing operations in Ireland by the HPRA and by the regulatory authorities in global markets where the company operates (US/Canada/Japan etc).
Job Spec:
Designs and implements a quality management system for the plant in conformity with overall corporate Quality policy. Provides leadership abilities and direction for all site quality programs and operations which are governed by GMP regulations or are part of the quality management system. The Ireland manufacturing plant is scheduled to be built out, validated, and commissioned over an approximate 2.5-year period. In addition to developing a team and implementing an effective quality management system at the site, the Quality Director will provide key input and QA approval for specifications, design and validation activities and QA/QC support for future manufacturing activities.
   » Responsible for developing the strategic vision for the Quality organization and supporting the execution of the site goals. Key member of the Site leadership abilities Team.
   » Designs and implements the overall quality management system and the connected site quality policies and procedures in conformity with corporate policies and in compliance with global regulatory requirements in partnership with other site functions and in conformity with global regulatory regulations and guidance. Plan resources for QA and QC to ensure the function achieves its regulatory obligations, and operational and strategic goals.
   » Review and approval of initial facility and equipment specifications, designs and validations and has overall responsibility (in conjunction with operations and engineering teams) for ensuring that the site project validation and regulatory approval is delivered in conformity with the overall project plan and timelines.
   » Responsible for ensuring that commercial (and where significant investigational) release of products is conducted in conformity with applicable legal requirements (i.e. QP release etc), including batch record review, analytical testing, and investigation / resolution of deviations and connected investigations.
   » Responsible for the Quality Control organization, including internal/external microbiology, chemistry and stcapability testing.
   » Manage the interface between the Ireland site and the corporate Quality organization and ensure that the objectives of the site quality organization are aligned and delivered in conformity with corporate objectives and quality plans.
   » Responsible for the selection, functional design, growth and development of the Quality organization staff at all levels.
   » Ensures that all suppliers are appropriately qualified and for the maintenance of Quality oversight of suppliers and vendors supporting product manufacturing and testing, including audits, quality agreements, etc.
   » Generation and review of site related information and data for regulatory submissions and approval of submissions related to the site
   » Responsibility to ensure that site is validated in conformity with global requirements and for maintenance of the validated state of all required systems, equipment, and processes on an continuing basis through oversight of the site validations function.
   » Responsible for compliance of the Ireland manufacturing site - understand current and new regulations and guidelines and ensure that appropriate processes and procedures are implemented.
   » Responsible for interaction and relationship with all regulatory and statutory compliance authorities as related to the scope of operations and functioning of the site (HPRA/FDA/Health Canada/EMA/PMDA etc)
   » Responsible for development and design of key quality metrics for the site and in conjunction with site colleagues, the measurement of the quality team's performance against Key Performance Indicators.
   » Creates strategic plans to improve the quality and efficiency of the QA organization.
   » Responsible for overall quality budget and connected elements (Capital/Headcount/Spending) as part of the overall site budget

Person Spec:
Comprehensive working and theoretical knowledge of current pharmaceutical Regulatory/Compliance requirements, especially those applicable to sterile product manufacturing
Excellent leadership abilities and organizational expertise. Strong analytical and strategic thinking.
Excellent communication expertise. capability to represent the organization during regulatory inspections and other interactions.
Knowledge of fundamental technical and scientific concepts, tools and practices employed in manufacturing and testing of pharmaceutical products, including chemical and microbiological testing.
Demonstrated practice building a high capcapability organization and developing people. Strong situational leadership abilities expertise (e.g. teambuilding, facilitation, conflict resolution, persuasion, negotiation).
Budget development and management.
BSc in chemical or biological science or chemical engineering. Postgraduate degree (MS / MBA) preferred. Must be eligible to act as a Qualified Person, per EU regulations.
practice Required:
Proven senior leader with at least 10 years-practice working in a sterile pharmaceutical manufacturing organization with at least 5 years of senior management practice (at Director / Site leadership abilities Team level) in a quality function.
Candidates with Senior Manager (or equivalent) practice of a key site quality function must have at least 8 years-practice in this function managing a quality function.
Sterile manufacturing practice an essential and Ophthalmic manufacturing practice an advantage.
Industry related knowledge:
   » Fully conversant with US and European regulatory/CGMP requirements
   » practiced in design, validation and operation of sterile manufacturing equipment and systems
   » Demonstrated practice of personnel and functional line management
   » practice of acting as a QP with broad knowledge of QP regulations and obligations and how these are applied across the quality management system
   » Thorough knowledge of global Quality systems and operational best practices
   » practice in leading interactions with regulatory agencies and demonstrated results in leading prosperous regulatory authority inspections
   » practice in lean manufacturing concepts and/or six sigma and their application within the quality system are a considerable advantage
leadership abilities:
Creates an impactful vision for the Quality function and communicates a strategy to align people, resources and management. Supports and develops the capabilities of the organization and staff
Proven track record of managing and developing teams. Sets high performance expectations and holds others accountable for results
Promotes a culture of technical excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, innovation, transparency, execution, quality and effective communication
Energetic, highly motivated, with an enquiring mind and passion for excellence and innovation in pursuit of business growth and success
Anticipates needs, assesses and manages business risks and organizational dynamics as well as their implications
capability to prioritize multiple work streams with a commitment to delivering quality results and overcoming obstacles and challenges in a time-sensitive environment
Agile & flexible - capability to adapt and work with all organizational levels
Demonstrates and espouses a simplified approach to maintaining compliance
Proven capability in development and deployment of strategic plans
Proven capability to work seamlessly across functions and international boundaries
10% of the time. 30-50% for the first 12 months during the initial start-up phase of the manufacturing facility project.
Ref: q.d.CC
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RFT Group - Pharmaceutical Division.


   » 6A Old Dunleary Road, Dun Laoghaire, Co Dublin
   » +353 (0) 1 2302400


Job Category: Customer Service [ View All Customer Service Jobs ]
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Salary: Unspecified
Degree: Unspecified
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Job Location: Westmeath
Company Type Employer
Post Date: 05/16/2018 / Viewed 12 times
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Company: RFT Group - Pharmaceutical Division.
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