What will you do?
Manage and lead the Quality Assurance (QA) Operations department and all aspects of the people process including hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and employee development
Responsible for resource management and for initiating timely resource planning for the QA Ops team based on production forecasts and business needs
Provide QA oversight, technical expertise and leadership across all aspects of product manufacturing from raw materials, through warehouse activities, engineering, quality control, manufacturing and operations support
Monitor and oversee the batch record review process, including escalation of issues and driving completion of quality records , Investigations, CAPA and Change Controls
Drives and owns Quality on the Floor facilitating the desired way of working’, quality culture and the 4i values through actions, coaching and mentoring
Manage completion of GMP documentation to the required standard and timescales, to ensure timely and efficient service for our internal and external clients
Prepare quality documents , technical documents, undertake investigations, review and approvals , Deviations and Complaints
Ensure new products, equipment and processes are effectively introduced to internal & external standards
Proactively drive and react to system trending (, complaints) to ensure ongoing quality performance.
Act as QA Ops representative during Regulatory Inspections and audits ()
Ensure own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved. Including standard lead-times and supporting the Business goals for
Embrace and actively drive Practical Process Improvements (PPI) and performance by identifying opportunities to improve quality / compliance, reduce cycle time, reduce COGs, and increase operational efficiency.
Partner with key stakeholders to prioritize projects aligning with the quality goals and objectives
Ensure that own, and teams work complies with GMP, Data Integrity & Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents ’s, BMR’s, Protocols, Guidance’s, etc.
Ensure own, and teams training is undertaken in a timely and GMP compliant manner before the task is undertaken and maintain an updated and compliant training matrix for the team
Maintain thorough understanding of international regulatory guidance, ISO, corporate and client requirements pertinent to the site, and to ensure that all work within the Quality department and across the aligned cell complies with these and with departmental procedures
Deliver effective leadership and communications in line with company rules, policies and procedures
Can act as back up for other managers in the quality organisation
Understand and ensure implementation of emergency procedures and safe systems of work
Ensure compliance with environment, health and safety rules, signage and instructions at all times
Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
How will you get here?
Minimum Science based degree in Chemistry, Pharmacy or Microbiology
Substantial experience minimum 10 years’ working in a pharmaceutical Quality department on a sterile site.
This position requires deep understanding and proven application of cGMP regulations and international guidelines in a sterile production setting.
This knowledge needs to be combined with clear decision making, pragmatism aligned with quality risk management principles to demonstrate release of product appropriate for commercial use.
Substantial Quality Assurance experience 5-10 years’ and hands-on’ knowledge of all Quality Systems required for a sterile manufacturing facility.
Understanding of the principles of sterile manufacturing.
Knowledge, Skills, Abilities
Demonstrated ability to make sound decisions regarding evaluation of GMP compliance, and leadership abilities in the management of QA oversight
Eligible to act as a Qualified Person’ as defined in 2001 / 83 / EC and 2001 / 82 / EC (as amended), is preferable but not essential
Strong working knowledge of the principles and guidelines for GMP as set out in the Orange Guide, Eudralex Volume 4,
Is not afraid to make decisions for the group. Holds self and others accountable in achieving goals
A proven track record of developing and leading a high performance team
Strong leadership skills with good collaboration, communication and problem solving skills
Excellent written and verbal communication skills to internal and external stakeholders
Ability to work in a fast paced, matrix environment essential
Capable of working to deadlines and prioritize multiple tasks
Flexibility to meet changing needs and priorities of the business