Senior/Principal Quality Lead - Hertfordshire

Senior/Principal Quality Lead - HertfordshireHertfordshireReference: 3157
  • Global Pharmaceutical Organisation
  • Senior or Principal QA Leads considered
  • Excellent package including bonus
  • Some remote working

We have a number of exciting roles within Quality Assurance for a global Pharmaceutical organisation in the South East of the UK including Senior and Principal Quality Leads.  These senior roles will design and implement Quality Assurance strategies.

Naturally, there is a competitive package for these roles including generous salary, bonus, some flexibility of working from home and other benefits you would associate with a world leader.

Responsibilities of the Senior/Principal Quality Lead:

  • Design and Implementation of Quality Assurance strategies 
  • Establish strong partnership/relationship with business stakeholders 
  • Define molecule/process/affiliate level approach with appropriate measures to enable oversight and management of Quality 
  • Assess specific risk areas on an ongoing basis, communicate to PDQ senior leadership and propose modifications to the Quality Assurance strategy where necessary 
  • Define the activities that need to be conducted to deliver the Quality Assurance strategy and provide evidence of effective implementation 
  • Lead the development of methodology including the use of data analytics and maintain related tools/procedures. 
  • Delivery of activities to assess Quality Assurance status 
  • Independently perform and lead Quality activities including preparation, conduct, presentation and timely reporting of outcomes, and evaluation of actions taken 
  • Group individual issues into systemic issues and areas of opportunity for process improvement beyond the individual findings 
  • Present observations and associated compliance risks to business stakeholders and Pharma representatives and prepare a written report where required. This should require minimal input from manager/report reviewer 
  • Ensure appropriate action plans have been developed and determine acceptability of evidence of compliance per the Clinical and Safety Finding Management (CSFM) process 
  • Demonstration of implementation of Quality Assurance strategy to Health Authorities 
  • Lead or support inspection preparation and management of Health Authority inspections. Activities including but not limited to: provide inspection training to staff, prepare, review and provide relevant inspection materials on request and presentation of Quality strategies and associated documentation during Inspections 
  • Participate in or lead departmental or cross-functional compliance projects and initiatives as assigned 
  • Lead the development and/or revision of PDQ processes and procedures including SOPs, Work Instructions, and risk assessment tools 
  • Provide education and/or training to business stakeholders as required 
  • Act as trainer and mentor for junior staff providing meaningful feedback on a person’s performance in close collaboration with their line manager 
  • Perform other tasks as assigned by line management 
  • Maintains highest level of awareness and expertise in GxP regulations and internal policies and SOPs 
  • Assess impact of new regulations and guidance on GxP activities 
  • Maintain in-depth knowledge of company policies, SOPs, and supporting documents related to drug development as well as FDA and EU regulations and ICH guidance documents (as applicable) along with any other national or international regulations that may affect drug development and post-marketing processes (as applicable) 

 

Requirements of the Senior/Principal Quality Lead:

 

Education/Qualifications: 

 

  • Masters, Bachelor’s degree or equivalent in scientific or quality-related field

 

Experience: 

 

  • Strong experience in the pharmaceutical industry
  • Good experience within GCP/PV/CS/GLP related discipline 
  • Demonstrated applied knowledge of clinical / pharmacovigilance / drug safety and regulatory requirements, as well as analytical, organizational and planning skills 
  • Project management experience with proven leadership, mentoring and coaching 
  • Desired: 
  • Proficiency in the conduct of GCP/GVP/GLP/CS audits 
  • Experience supporting regulatory authority inspections 
  • Ability to formulate clear business questions that can be answered with data 
  • Proficiency in utilizing data and visualization tools to generate insights 

Contact: Neil Dewsbury
Email: neil.dewsbury@zestbusinessgroup.com
Telephone: 0114 238 1728