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 Site Director. The Quality Director is a key member of the Site Leadership Team and will provide quality input and oversight on the design, construction, validation and operation of the new manufacturing facility, including creation and implementation of the quality management system.
The Quality Director will be responsible for recruiting and developing the staff needed to build 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.
Designs and implements a quality management system for the plant in accordance with overall corporate Quality policy. Provides leadership and direction for all site quality programs and operations which are governed by GMP regulations or are part of the quality management system. In addition to developing a staff 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 Team.
- Designs and implements the overall quality management system and the associated site quality policies and procedures in accordance with corporate policies and in compliance with global regulatory requirements in partnership with other site functions and in accordance with global regulatory regulations and guidance. Plans 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 accordance with the overall project plan and timelines.
- Responsible for ensuring that commercial (and where relevant investigational) release of products is conducted in accordance with applicable legal requirements (i.e. QP release etc), including batch record review, analytical testing, and investigation / resolution of deviations and associated investigations.
- Responsible for the Quality Control organization, including internal/external microbiology, chemistry and stability 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 accordance 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 accordance with global requirements and for maintenance of the validated state of all required systems, equipment, and processes on an ongoing 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 associated elements (Capital/Headcount/Spending) as part of the overall site budget
Comprehensive working and theoretical knowledge of current pharmaceutical Regulatory/Compliance requirements, especially those applicable to sterile product manufacturing
Excellent leadership and organizational skills. Strong analytical and strategic thinking.
Excellent communication skills. Ability 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 experience building a high capability organization and developing people. Strong situational leadership skills (e.g. teambuilding, facilitation, conflict resolution, persuasion, negotiation).
Budget development and management.
Person Spec :
Degree in chemical or biological science or chemical engineering. Postgraduate degree preferred. Must be eligible to act as a Qualified Person, per EU regulations.
At least 10 years experience working in a sterile pharmaceutical manufacturing organization with at least 5 years of senior management experience (at Director level) in a quality function. Candidates with Senior Manager (or equivalent) experience of a key site quality function must have at least 8 years experience in this role managing a quality function. Sterile manufacturing experience an essential.
Industry related knowledge: US and European regulatory/CGMP requirements; Design, validation and operation of sterile manufacturing equipment and systems. Demonstrated experience of personnel and functional line management; Experience of acting as a QP with extensive knowledge of QP regulations and obligations and how these are applied across the quality management system.
Thorough understanding of global Quality systems and operational best practices. Experience in leading interactions with regulatory agencies and demonstrated results in leading successful regulatory authority inspections. Experience in lean manufacturing concepts and/or six sigma and their application within the quality system are a considerable advantage.
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.
Sets high performance expectations and holds others accountable for results.
Promotes a culture of technical excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication.
Anticipates needs, assesses and manages business risks and organizational dynamics as well as their implications. Demonstrates and espouses a simplified approach to maintaining compliance.
Works across functions and international boundaries.
During the initial start-up phase of the manufacturing facility project, travel his may be as high as 30% + for the first 12 months. Once the plant is operational, travel will be 10%.