Our client, a leading pharmaceutical company located in County Mayo, is recruiting for a Quality Director. This role is an exciting opportunity to join the leadership team within the company. The areas of responsibility include commercial, clinical and development operations oversight, bioanalytical laboratory management and quality oversight of biologics expansion project activity. The successful candidate for this Quality Director Biologics role will hold responsibility for providing competent, highly engaged staff to meet company and regulatory requirements.
The Quality Director, Biologics is accountable for the management of the Biologics management team and associated direct reports. The Director will drive and foster an ethos of continuous improvement, provide direction and input to all Biologics project activities to ensure appropriate quality design and risk management principles are captured from project initiation through to delivery.
The Quality Director Biologics must show the competence to drive forward Biologics Operation at the site and the skills to ensure that the function operates to meet/exceed defined targets. The Quality Director, will work collaboratively with the Executive Director of Quality Operations, Biologics Operations Director, Site Leadership Team, Global R&D & GPT in addition to other manufacturing sites to ensure company business goals and objectives, strategic objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and regional Ministries of Health are adhered to.
- Provide direction to all quality personnel in the Biologics Business Operation at the site, including commercial operations quality activities: Compliance, QP/product release, Bioanalytical Laboratory, Clinical & Development quality activities: Compliance, QP/Product release and Biologics site strategic project management team.
- Manage and motivate all employees through effective communication, coaching and influencing skills.
- Hold performance review meetings and manage staff performance according to company policy.
- Maintain resources and staff capacity in line with business needs including the recruitment and management of staff.
- Coach and develop team to support the Company’s succession planning and Development Plans.
- Create, foster, implement and sustain the culture of Quality in area of responsibility and site in conjunction with the site compliance/quality team.
- Foster a strong working relationship with DS, R&D & relevant global functions as it relates to the Biologics commercial and development activities.
- Assist in the planning and of the annual site Quality Plan/ & quality site initiatives as it pertains to Biologics operations. Implement and manage said initiatives to full delivery.
- Evaluate and assess all new and revised global regulations and standards and ensure implementation is planned and executed in accordance with company requirements.
- Ensure quality focus is maintained in site strategic initiatives and participate in strategy development and deployment for the Biologics operation.
- Participate in product and technology business assessments, as required.
- Ensure that quality requirements and support is provided for site expansion and new product introduction projects as it relates to Biologics division of the business.
- Acts as Quality Lead for Biologics operations: Commercial, Clinical & Development manufacturing and testing activities
- Manage and provide guidance to Biologics management team across compliance, product release, clinical/development, site expansion projects and bioanalytical.
- Plan and deploy resources and assignments as required. Ability to prioritise competing activities and manage resources accordingly.
- Manage the application of GMP requirements and the implementation and continuous improvement of the Quality Management System and Policies.
- Provide quality input for all activities undertaken within the Biologics Operation at the site and liaise with company DS manufacturing site to represent the company in all business unit Ministries of Health inspections, ensuring the unit is audit-ready while ensuring any non-conformances and open commitments related to the Biologics operation are addressed.
- Ensure focused management of Bioanalytical data in conjunction with laboratory team, Operations function and sister DS manufacturing site.
- Participate in the Biologics Operational Excellence program providing quality input.
- Act as Biologics Business Operation Quality Representative in all MOH inspections.
- Prepare, attend, and participate in business update meetings for Biologics business as required.
- Attend and participate in strategic planning meetings and off-site events as they relate to Biologics business.
- Roll-out employee engagement and business update meetings for area of responsibility.
- Attend and participate in customer and site visitor meetings as necessary.
- Represent the Biologics quality group at internal/external meetings as required.
- Attend all meetings as required or arrange an appropriate deputy: (non-exhaustive list):
Education, Experience and Skills
- BS/MS in Scientific Discipline. Must be qualified / recognised to hold Qualified Person status.
- 10+ experience in Pharma/Biotech industry with 5-7 years’ leadership experience in Quality or Quality related function.
- In-depth and current knowledge of all relevant GxP and Quality System requirements (US, EU) for pharmaceutical and biotech, manufacturing and related activities.
- Experience of leading and managing regulatory inspections with Global Health Authorities and of interacting with and representing the company to Health Authorities, their agents, or related entities.
- Excellent analytical, communication, managerial and leadership skills.
- Can develop and implement programs to establish and maintain quality standards of existing products and services. While developing programs to focus employees on quality improvement.
- Can develop policies, procedures and methods to check product, material, components and/or operational quality and improve same and develop, assures and maintains the quality of products and processes, including standard procedures, quality audits/review, process reengineering, etc.
For further information on this Director role in Mayo please contact Caroline Kingston on 0868395531/ firstname.lastname@example.org
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