Quality Manager

The Quality Manager's role will ensure compliance with the Bayer GMP/GDP Quality Management System (QMS), ensuring all applicable regulatory requirements are met to maintain required authorisations and licences for the manufacturing and supply of products. The role is instrumental in the implementation and continuous improvement of the QMS, ensuring that the Pharma and Consumer Health divisions are in compliance with all relevant Bayer guidance and regulatory legislation, including Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). The successful applicant will act as deputy for the UK & Ireland Country Quality Head and will perform the role of Responsible Person (RP), ensuring that the conditions of the Wholesale Distribution Authorisation (WDA), applicable EU Directives/Regulations and MHRA Guidelines on GDP are complied with. Key Tasks

• Lead the development and maintenance of the GDP/GMP Quality Management System (QMS), leveraging best practices and innovative approaches. Ensure that all quality systems and processes are documented and maintained in accordance with applicable regulations and standards.
+ Monitor the effectiveness of the QMS, including maintaining appropriate KPI to demonstrate continued compliance. + Drive and implement a culture of data-driven decision making and continuous improvement. + Demonstrate a strong sense of ownership and accountability for the QMS.
• Execute various QMS processes such as:
+ Change Management, including change control coordination, risk assessment, and impact analysis. + Deviation and Quality Issue Management, including root cause analysis, corrective and preventive action planning (CAPA), driving closure and effectiveness monitoring. + Risk Management to identify, assess, and mitigate risks
• Perform roles and responsibilities of the Responsible Person
• Foster a culture of quality excellence by promoting awareness and engagement across the organisation, emphasizing the importance of quality in all aspects of commercial operations. This includes supporting, coaching and delivering engaging training on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Quality requirements and processes.
• Provide expertise, guidance and support to the Country Quality QMS Centre of Excellence by delivering world-class process documentation templates for global adoption by commercial organisations.
• Proactively participate in internal and external audits and inspections as needed.
  
  Education in Life Sciences, e.g. bachelor's degree in Pharmacy, Medicine or Chemistry, or other related discipline
• An in-depth knowledge and experience working in a Pharmaceutical regulated environment, and the standards which must be met to assure patient safety and product quality.
• An understanding of the quality requirements associated with Medical Devices, Cosmetic and Food Supplement products.
• Eligible to act as a Responsible Person
• Trained/Qualified GMP/GDP Auditor
• Strong communication, critical listening, negotiation, and interpersonal skills.
• Problem and analytical solving skills including the ability to systematically gather and analyse information from a variety of sources, identify implications of data, ask effective questions, draw appropriate conclusions, generate viable alternative solutions to a question or problem and have the ability to apply a risk-based approach to evaluate the consequences of choosing each alternative.
• Ability to make and act on decisions while balancing speed, quality and risk.
• Change agility and experience in leading others through change and ambiguity.
• Ability to provide innovative ideas or alternatives that create competitive advantages
• High organisation awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally.
• Ability to work effectively in a matrix environment including to drive results through influence and coaching.
• Digital skills including proficiency in a range of computer applications such as SAP, Microsoft Word, Excel, PowerPoint, Teams, SharePoint, Power BI and AI.
  
  At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.
Bayer is an organisation where decisions are made together and where innovation cycles are in 90 days sprints. Our operating model (Dynamic Shared Ownership (we call it DSO) is a reimagined way of operating a multinational company which moves at speed and scale with the goal of delivering on our vision. Being part of #TeamBayer means that you are part of our vision and of our future - delivering to our farmers, patients, and consumers. https://www.bayer.com/en/strategy/strategy As Quality Manager, you will have the opportunity to drive the development, implementation and sustainability of world-class and innovative quality management processes, systems and tools to ensure excellence. You will play a pivotal role in ensuring quality and compliance activities for the commercial operations.


• Competitive compensation package consisting of an attractive base salary and annual bonus. Individual bonus can also be granted for top performance awards.
• 28 days annual leave plus bank holidays
• Private Healthcare, generous pension scheme and Life Insurance
• Wellness programs and support
• Employee discount scheme
• State of the art offices
• International career possibilities
• Flexible and Hybrid working
• Help with home office equipment
• Volunteering days
• Support for professional growth in a wide range of learning and development opportunities
• We welcome and embrace diversity providing an inclusive working environment
The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.