£85,000 - £100,000 Plus Benefits
My Client is rapidly expanding and requires an experienced Technical Director to come on board to manage and influence the QA, RA and PV departments as they continue to grow.
- To head all technical departments (RA, QA, PV)
- Responsible for Technical Projects and Strategic Programs worldwide
- To ensure they are compliant with all Regulatory and Quality requirements and maintain and update all UK license applications
- To provide technical manufacturing, regulatory and analytical support for transferring technology to third party CMO’s
- Act as a Qualified Person to release batches in EU
Key Roles & Responsibilities:
- To manage the Technical teams (RA, QA, PV) and communications with Contract Manufacturing Organizations (CMOs)
- To write, review and/or maintain all GMP and SOPs
- To keep abreast of the regulations of the Medicines and Healthcare Regulatory Agency (MHRA) and additional European regulatory legislation and guidelines.
- To ensure the company’s manufacturer (MIA), wholesale dealer (WDL) and Controlled Drugs (CDL) licenses are maintained to allow importation and distribution of all company’s products and all vendors and customers are compliant with GMP, GDP, MHRA guidelines.
- To support the Group’s regulatory department with eCTD and NeeS submissions by either National, DCP or MRP procedures. To manage/submit variations to existing license as and when required.
- To co-ordinate with EU QPPV for PV activities relating to and respond to medical information queries from patients
- Act as Qualified Person (QP) to release batches
- To finalize Regulatory and Manufacturing Strategy for Technology Transfer with each CMO and give technical support to departments on data requirements for Technology Transfer and evaluation of risk
- To set objectives for commercial, regulatory and technical resources within the department and external consultants to ensure launch objectives are achieved in line with company expectations
- To mentor, train and develop the Technical Operations team
- To agree department budgets and ensure spend is within agreed limits
- To scope and make recommendations to management for potential vendors for new product opportunities
- To identify and report key milestone status in all new product launches
- To visit Contract Manufacturing Organizations (CMOs) based on an agreed plan and for issues resolution and recommend ways to make the process efficient
- To communicate with key partners (internal and external) to ensure agreed milestones / objectives are achieved
- To continuously assess and report the resources allocated to a project to realign priorities and expectations if they change significantly during the life of the project launch process
- To reduce Cost of goods by recommending and discussing options with CMOs including alternate sources of API
- To undertake ad hoc duties on behalf of the General Manager as and when required.
- To comply with the office policies and guidelines
Knowledge and Experience Required:
- Understanding of European regulatory guidelines, regulations and procedures
- Experience in manufacturing and technology transfer of oral solids to CMOs
- Knowledge of GMP and GDP
- Knowledge of Regulatory Affairs esp MHRA
- Experience of managing a multi-cultural team
- Understanding of the timescales of the approval processes within the MHRA
- Qualified Person for EU Batch Release
- Understanding of pharmacovigilance practices and procedures
- Understanding of the drug development and manufacturing process
This is a genuinely exciting role which can lead to much greater things within the company as this client continues to expand and grow their product portfolio and launch into new markets, creating a platform for the Technical Director to make strategic business decisions, which will aid in the company’s growth.