Senior QP

Thermo Fisher Scientific
29 Sep 2016
11 Nov 2016
Contract Type
Company Information About Thermo Fisher Scientific Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $12 billion, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and UnityTM Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit Job Description Job Title: Senior Qualified Person Reports To: Lead Qualified Person Group/Division: BSD Career Band: 7 Job Track: Management Position Location: Horsham Number of Direct Reports: approx. 5 Position Summary: The Senior QP will provide support to all appropriate and relevant activities within Fisher Clinical Services, Horsham. The job has three primary functions, QP certifications and declarations, technical contribution to the operations of FCS Horsham and conducting audits. The senior position will fulfil a point of contact and facilitation for the QP group in the absence of the Lead QP, and will also provide day to day routine allocation of duties in the QP group. The jobholder will form part of the ‘QP team', supporting the QP certification activities, maintaining an up to date awareness of current legislation and contributing to QP policies. Key Responsibilities: To provide QP certification in compliance with regulatory requirements and if required, specific client technical agreements. To provide a point of contact and deputy when the Lead QP is absent. To provide QP GMP declarations including on site audits if required, in support of importation activities. Mentoring (Sponsor) of trainee QPs To support routine allocation of tasks within the QP group. Day to day scheduling of the QP team. To provide management and mentoring to direct reports. Conducting internal and external audits as required To act as the Quality Lead, the primary contact point for Quality for major clients. Provision of GMP training. To provide information and training on the EU QP roles and responsibilities to FCS personnel in the UK and outside the UK. 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 informed where appropriate. To provide technical advice and support in the preparation of Technical Agreements. Support client audits with QP input. Minimum Requirements/Qualifications: Meets the EU requirements for Qualified Person status Management/leadership experience Non-Negotiable Hiring Criteria: Experience in acting as a QP for IMPs is an advantage Knowledge of pharmaceutical development process desirable Experience of managing a group desirable. Teamwork especially in a matrix management organisation. Ability to influence across functions across Fisher sites and across companies to achieve objectives. Flexible and adaptable, with strong customer management skills. Must be highly responsive whilst maintaining strategic direction. Needs to be comfortable with ambiguity. Ability to interpret the regulatory requirements in a pragmatic manner to support both the client study needs and that of the business