Quality Assurance Department Manager

The Role

• The role is to provide leadership & management of the Quality Assurance and Quality Control activities at the Mirfield Site. Managing the formal planning and control of activities to meet anticipated product release dates. Ensuring that team operational targets, product quality, customer service and safety objectives are met
• To lead forward planning and managing the resource requirements of the QA and QC departments
• Recruitment, training, and performance management of team members to ensure the correct number of suitably qualified people are available
• Collation and reporting of quality metrics at site and business level
• Interpreting European and US cGMP guidelines and regulations and applying to ways of working and integrating into the QMS at site
• Champions key quality systems on site: Change Control, Validation and Cleaning Validation
• Participate in and lead regulatory and customer audits
• Provide expertise and support on Quality and cGMP aspects to other departments
• Ensures that all incidents, OOS and OOT results are investigated, root caused and appropriate CAPAS are put in place
• Ensures effective communications across the QA & QC teams
• Identifies, develops & initiates continuous improvement initiatives in QA & QC
• Provides team leadership & motivation to ensure the achievement of targets & objectives
• Monitors team’s performance identifies individual & team training requirements, develops & initiates plans to improve individual & team performance
• Monitors & controls spend within defined budget & parameters
• Develops, monitors & measures Key Performance Indicators
• Responsible for site compliance training

About You

• The jobholder should ideally be educated to degree/HNC level or equivalent or have an NVQ level 3 with relevant experience
• Pharmaceutical GMP experience is essential
• A strong operational excellence/continuous improvement background essential
• In addition, you should be receptive to new ideas and poses a broad knowledge of the business, effective communication, interpersonal, organisation & decision-making skills with the ability to lead, manage and motivate teams within a pressurised environment
• People Leadership
• Speed & Rigour in Execution – able to multi-task and prioritise, excellent attention to detail
• Innovation – commitment to continuous improvement
• Results Driven – able to focus on achieving outcomes and delivering KPI’s. Self-motivated and disciplined with an eye on the end goal
• Excellence Focus – uses professional expertise to ensure excellence. Brings in outside perspectives and best practices
• Deep knowledge of ICH guidelines and cGMP requirements

Benefits

• Flexible working:
• 40 hours per week, typical hours are 08.30-17.00 with a 30-minute lunch break, hours are flexible the company core hours are 10.00-16.00
• Annual leave:
• 25.5 days plus bank holiday (the 0.5 day is for Christmas Eve)
• Then an additional day after 5, 10 and 15 years’ service up to 28.5 days
• 8 days can be carried over or cashed in
• Enhanced Maternity, Paternity and Adoption leave:
• Over a years’ service get enhanced parental leave
• Enhanced maternity which is 13 weeks full pay then 26 weeks half pay
• Enhance paternity is 2 weeks full pay
• Sick pay:
• 4 weeks full sick pay every 52 weeks
• Income Protection
• Business and Personal Travel Insurance
• Full personal travel insurance for employee, partner and children
• Life Assurance 4 x salary
• Private Medical Insurance (Two-thirds of the premium funded by the Company; remainder by employee)
• Premium varies dependent on type of cover i.e., single, self & partner, family etc
• Sports and Health Club Reimbursement
• Pay 70% of gym or sports clubs up to £1200 per year
• Cycle to work
• Annual Health Checks
• Employee Assistance Programme