|Senior Director, Quality|
In collaboration with the Vice President Quality, the Senior Director Quality is responsible for Quality oversight and execution of GMP and GDP activities in Europe and supports the development and execution of Quality strategy globally.
Design and oversee the quality systems necessary to support EU commercialization of the company’s product portfolio, including obtaining the necessary licenses to allow batch release (MIA) and distribution (WDA) within the EU.
The primary contact with European Health Authorities (EMA, HPRA, etc.) with responsibility for leading inspections and preparing Quality-related correspondence.
Responsible for managing suppliers and vendors in the European region, and globally as needed.
Responsible for ensuring the business processes, to enable the Quality policies and systems, are installed and effective through surveillance and Quality Systems management.
Leverage the expertise and collaborate pro-actively with cross-functional colleagues across the organization and with external service providers.
- Collaborates with the VP Quality to promote quality related company objectives and systems.
- Fulfills responsibilities as a key member of the Dublin leadership team.
- Develops and executes the project plan for Quality deliverables to support EU commercialization of the company product portfolio and specifically to acquire the applicable license approvals.
- Acts as primary contact with European Health Authorities (EMA, HPRA, etc.) and is responsible for hosting regulatory GMP/GDP inspections and preparing quality-related correspondence.
- Acts as EU Qualified Person responsible for batch disposition and certification OR oversees and facilitates contract QP service.
- Acts as Responsible Person in accordance with Good Distribution Practice (GDP) regulations.
- Manages Supplier Qualification activities in area of responsibility. Negotiates and approves Quality Agreements. Accountable for supplier audit schedules and remediation plans and provides support for inspection readiness at key sites.
- Supports routine product release and stability testing activities to ensure product quality and regulatory compliance. Maintains batch records, advises on investigation of deviations and assesses change controls for batches prior to release by Quality.
- Provides Quality oversight for the creation and revision of method development reports, method transfers and validations, general technical reports, analytical methods, laboratory procedures, and review of critical raw data.
- Participates in the preparation and/or review of internal SOPs, investigations, specifications, methods, and technical reports.
- Ensures that all pre-marketed and marketed product stability programs are in compliance with pertinent regulatory requirements and commitments.
- Provides input and direction for the quality and compliance aspects of GMP/GDP projects which support the European business (e.g. serialization).
- Liaises with colleagues in CMC, Regulatory Affairs, Supply Chain and R&D teams on quality and compliance matters.
- Appropriate science or engineering based degree (advanced degree an advantage) e.g. Qualified Person or Responsible Person is desirable.
- You will have an outstanding track record 10+ years-experience at leadership level in the pharmaceutical industry, including quality assurance, quality systems, auditing, compliance, pharmaceutical manufacturing and distribution, and/or new product introduction.
- You will possess a thorough knowledge and understanding of global cGMPs, laws and regulations pertaining to pharmaceutical product development, laboratory operations, commercial production and supply.
- Experience with regulatory inspection procedures, creation and improvement of quality systems and risk-based decision making is required.
- Experience in related job functions, e.g. manufacturing, technical support, customer relations and/or regulatory is an advantage as is demonstrated experience with managing major organization changes and successful multi-functional project implementation.
- Recent experience in achieving EU licensing approvals (MIA, WDA) is desirable.
- You will be an independent, experienced leader with a strong results orientation, positive attitude and a sense of urgency to get things done.
- You will demonstrate a high level of personal and professional integrity and trustworthiness with strong work ethic.
- You must have the ability to lead, influence and collaborate effectively within cross-functional team environments, focusing on accountability and meeting and exceeding expectations as a team.
- You will possess a demonstrated ability to engage effectively with others and solve complex issues in a timely, efficient manner.
- You must possess strong technical writing skills, ability to communicate with all levels in the company, and to act as Quality voice both internally and externally.
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