We are currently looking for a Product Operations Manager to join a global biotechnology company based in the Cambridge area. As the Product Operations Manager you will be responsible for ensuring that in-vitro diagnostic (IVD) activities are developed and delivered in a manner that is commercially effective, value driven and focussed on the patient.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Product Operations Manager will be varied however the key duties and responsibilities are as follows:
Define and plan the delivery of the objectives, goals and targets of the operations department.
Manage and supervise the lab team in line with the achievement of strategic and operational goals.
Promote effective and efficient use of available tools, technologies and other resources with a focus on value, impact and relevance of outcomes to both the business and the patient.
Customer Liaison and Communications
Promote a customer-focused operational policy taking account of broad stakeholder needs (internal and external) and in particular partner laboratories, patients, and healthcare professionals.
Provide direct field support to partner laboratories, travelling to site as needed, in order to equip them with the skills and expertise necessary to deliver a high-quality test service.
Market Surveillance & Vigilance
Together with the regulatory and quality functions, validate and manage vigilance incidents, IVD issues and related corrective actions.
Promote engagement and dialogue with users of products to maintain focus on proactive and preventative assessment & surveillance activities while ensuring reactive issues are addressed effectively and in a timely manner.
Contribute to the development of annual plans for reactive and proactive market surveillance activities based on inputs from end users, the team, and other market analysis activities.
Quality Management & Regulatory Affairs
Ensure that the procedures and policies of the Quality Management System (QMS) are maintained, deployed, and adhered to in all activities executed.
Contribute to implementing, updating, adapting Standard Operating Procedures (SOPs) and other QMS documentation.
Participate in any relevant internal audits including the identification and implementation of any required corrective actions.
Work with the marketing function, to ensure that proposed market actions on products are robust, consistent, and effective and appropriate in reference to legal and regulatory stipulations.
Support the finance function, by liaising with suppliers and customers on purchase requests and order fulfilment.
To be successful in your application to this exciting opportunity as the Product Operations Manager we are looking to identify the following on your profile and past history:
1. Postgraduate qualification in a relevant scientific, life-sciences, engineering or related discipline.
2. At least 4 years' experience in an IVD operational management role.
3. At least 2 years' experience in supervisory/people management role.
4. In depth knowledge of IVD development and commercial delivery.
5. Prior laboratory management experience.
6. RNA handling and RT-qPCR experience.
7. Broad knowledge of molecular biology techniques.
8. Experience of working within an ISO13485 or similar regulated environment.
9. Up to date knowledge of IVD regulatory pathway in UK, EU and US.
10. Strong project management skills - track record in planning and executing complex projects.