QAM Specialist for Pharma & Chemistry Candidates @ Novo Nordisk

Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases.

Job Title:    QAM Specialist

Job Description:

Key responsibilities:

Categorize in headlines the key responsibilities that demonstrates the variety of roles that the organisation expects the position to fulfill.

Department responsibility:

• Assist in the implementation/maintenance of the Novo Nordisk Quality Management System in Regions and
• Staff functions, ensuring focus on business critical issues that may have an impact on NN license to operate and inspection readiness in these areas.
• Mediate contact between QAM customers and HQ for resolution of various quality-related issues.
• Initiate and support continuous improvement initiatives when identified.

Personal responsibility:

Execute the above for areas of direct responsibility

Main job tasks:

For each headline indicated above the job tasks should be described in more detail

Compliance:

• Support development, implementation, maintenance and continuous improvement of the quality management system in Regions and Staff functions
• Coordinate between units in Regions, Staff functions, and HQ regarding compliance/ other quality related issues
• Specialist support/guidance to Regions and Staff functions, on ad hoc basis
• Timely follow-up on defined goals and tasks

Training:

• Conduct training courses on quality processes for Regions. E.g. Introductory QA Course, Advanced QA Course,
• Lead Auditor & GDP Course, Advanced Lead Auditor & GDP Course
• Train Regions’ business partners in compliance related matters in order to improve the quality level for handling of NN products at all steps in the distribution chain, as agreed with affiliate
• Provide ad-hoc training as requested

Projects:

Project involvement representing the interests of Regions.

Department specific:

Support maintenance of QAM owned SOPs
Support the colleagues from Regions joining QAM on job rotation
Initiate/propose/roll-out improvement projects
Necessary reporting as requested
Substitute for other QAM Supporters as needed

Scope of Authority:

Assigned acts of authority (QMS requirements) – also include information on independence and decision-making authority
Practices with minimum supervision from Manager; subject to approval from Manager
Communication and Stakeholder interaction:

Key stakeholders
Operations (Affiliates, Business Areas, Regions)
Staff areas
Corporate Quality
Limited interaction with stakeholders outside NN
Type of communication
Able to establish contact, connect and interact with stakeholders on all levels
Written and spoken communication of facts, practices and policies (email, phone, skype and F2F meetings) including presentations
Able to present topics and facts – simpler as well as complex – in an engaging, simple and understandable manner
Proactively engages with stakeholders at all levels in the value chain to ensure alignment and mutual understanding
Innovation and change:
High and pro-active
Takes initiatives for projects or improvements. Contributes with improving/innovative ideas.
Is able to, independently, to take charge and drive/launch solutions
Seeks and shares better practices and knowledge with colleagues, peers and other relevant stakeholders in the value chain.
Geographic responsibility:
Direct/functional influence on QA and stakeholders in Operations and Staff areas in HQ
Tasks and responsibilities impact operations in a wider and global Novo Nordisk business context
Knowledge, skills and experience:

Minimum knowledge required to fulfil job responsibilities

Education:

University/equivalent degree (Pharmacy, Medicine, Biology, Chemistry, Engineering or similar

Qualifications: 

Education:

University/equivalent degree (Pharmacy, Medicine, Biology, Chemistry, Engineering or similar

Experience:

• MSc: and 5+ years relevant experience
• BSc: and 8+ years relevant experience
• Broad knowledge/experience in biopharmaceutical industry
• Experience in at least 2 areas of NN (Affiliate, Quality, Product Supply, Clinical Development, Marketing, Sales, Regulatory) for at least 3 years each
• Experience with GMP/GDP on operational/decision level for at least 3 years
• Experience from international work within or outside NN
• Thorough knowledge of/experience with Quality and the Novo Nordisk Quality Management systems
• Thorough understanding of relevant regulatory requirement
• Understands the Novo Nordisk business in a wider and global context
• Master stakeholder management
• Master change management

Personal skills:

• Fluency in English (written and spoken)
• Computer skills
• Good presentation skills for various audiences
• Good analytical skills
• High level of integrity
• Flexible and ready for change Cultural aware
• ​Engaged and able to drive own performance

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