30+ days ago
At our site in Swindon, Thermo Fisher are forging partnerships that are transforming the industry, creating new business models between pharma companies and their pharma service providers. We are pioneering solutions that are driven by client needs.
To provide end-to-end QA oversight of the Swindon site manufacturing facility and support functions ensuring product is manufactured in accordance with the site licences and that all associated quality documentation is timely reviewed and approved in compliance with internal and external cGMP requirements. This role requires the ability to apply cGMPs in the manufacturing environment in a compliant and pragmatic manner. Understanding of facility design requirements and operating principles for sterile/aseptic manufacturing. This is a client facing role.
What will you do?
Manage and lead the 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 e.g. Deviations, 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 e.g. SOPs, technical documents, undertake investigations, review and approvals e.g. Change Controls, Deviations and Complaints
Ensure new products, equipment and processes are effectively introduced to internal & external standards
Proactively drive and react to system trending (e.g. deviations, complaints) to ensure ongoing quality performance.
Qualification/validation doc review
Process and Cleaning oversight
Act as QA Ops representative during Regulatory Inspections and audits (e.g. client and corporate)
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 e.g. RFT and OTD/ OTIF
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 e.g. SOP’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
Attracts, hires, and develops exceptional, diverse talent empowered to excel in the Thermo Fisher Scientific culture
Defines and employs effective retention strategies to ensure team stability and focus
Actively engages in career management opportunities with team members to maximize impact for both the individual and the company
Who are we looking for?
Minimum Science based degree in Chemistry, Pharmacy or Microbiology
Substantial experience 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 and ‘hands-on’ knowledge of all Quality Systems required for a sterile manufacturing facility. Understanding of the principles of sterile manufacturing.
Demonstrated ability to make sound decisions regarding evaluation of GMP compliance, and leadership abilities in the management of QA oversight
Able to work effectively with Clients
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, U.S. 21CFR part 210/211 and other relevant regulations
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
Wants to learn and have a natural curiosity to understand systems and processes
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
Experience of developing and influencing business strategy is desirable
Experience of leading, supervising and motivating a team
What’s in it for you:
Competitive base salary
Free on-site car parking
Private medical insurance
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
With Thermo Fisher Scientific, it’s not just a career. It’s a chance to realise your best – professionally and personally.