Qp Lead

**Position Summary**:
The QP will provide support to all appropriate and relevant activities within Fisher Clinical Services, Horsham, and is encouraged to provide significant to support clients and colleagues across the EMEA region

The job has three daily tasks, QP certifications and IMP declarations, technical contribution to the operations of FCS Horsham and conducting audits. This will take the form of international assignments such as US, Japan, India and European destinations. In addition, this will encompass significant diversity in dosage forms such as Sterile, Biologics, Solid oral and liquid dosage forms. The EMEA QP will be encouraged to collaborate closely directly and provide consultative approach to small biotech’s through to large blue chip pharma organizations.

The QP community at Thermofisher Pharma Services group is significant and covers many different sites in the network. Is encouraged that the job holder interacts and is as an active member of this QP community, entering into QP agreements, providing thought leadership and developing technically. Attendance and speaking at external forums with cascade of technical detail to the QP community. EMEA QPs engage with Trainees QPs and provide mentoring, development, training and guidance to those looking to qualify.

This is a fast paced and changeable environment which requires intermediate and final QP certification over large Global supply chains as well as small compassionate use supplies.

**Key Responsibilities**:

- To provide Final QP certification in compliance with regulatory requirements and if required, specific client technical agreements.
- To provide QP GMP declarations including on site audits if required, in support of importation activities.
- Negotiate QP to QP agreements, Quality technical agreements and other agreements in the oversight of the supply chains.
- Conducting internal audits as required globally
- To act as the Quality Lead, the primary contact point for Quality for major clients.
- Provision of thought leadership and actively providing new views on cutting edge regulatory/legislative and GxP training, completing blogs, internal and external speaking appointments as required.
- To provide information and training on the EU QP roles and responsibilities to FCS personnel in the UK/EU and Internationally.
- Provide support and mentoring to Trainee and newly qualified QPs.
- Support EMEA region in multisite initiatives to improve quality and compliance.
- Provide input/authoring on all aspects of the Global Quality management system, actively providing support on new policies and procedures as they are written and adopted.
- Support in larger scale investigations which could mean liaising with sites across time zones and companies as well as in the extensive PSG network.
- Provide support to Business Development/ Sales and Project Management at pre-contract stage to assess new contracts.
- To maintain an up to date awareness of the regulatory issues affecting the clinical supplies process keeping relevant FCS colleagues advised where appropriate.
- To provide technical advice and support in the preparation of Technical Agreements.
- Support client audits with QP input.
- Potential for addition to multiple licenses in the region if desired.
- Developing expertise in EAP, Compassionate and named patient release globally.
- Consultation on appropriate Comparator sourcing strategies
- Advising on appropriate blinding processes and techniques.

**Minimum Requirements/Qualifications**:

- Meets the EU requirements for Qualified Person status
- Experience in acting as a QP for IMPs is an advantage
- Knowledge of pharmaceutical development process desirable
- Be willing to step through technical and leadership training and investment to complete a thorough development process to focus on individual contribution as SME or Leadership progress.
- Actively willing to join external communities to drive and cascade key GxP and legislative changes into the business.