R&D Quality Expert within CMC and Devices
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Would you like to help us bring new treatments to patients with skin conditions world-wide? Would you like to play a key role in driving GxP compliance for CMC and Devices in support of LEO Pharma’s growing R&D pipeline? Are you looking for a job where you can use your large Quality insight and impact the quality processes of a growing VP Area? Then this is the job for you!
The job
You will be part of the newly established CMC & Device Project Management and Business Support organisation where you will work in close collaboration with line of business stakeholders in the CMC Design & Development VP Area. Together you will ensure that LEO Pharma’s quality processes and capabilities are maintained and in line with health authority expectations and industry best practice.
An overview of your primary responsibilities are:
- Support the VP and CMC Design & Development Leadership Team to develop and drive the strategy for and implementation of a Quality agenda
- Recommend and support quality and compliance decisions covering CMC Design & Development responsibilities (Combination products, Biopharm, Device, Small Molecules activities for pre-Phase 1 to MAA and initial launch activities)
- Scope, plan and coordinate Quality projects to meet LEO Pharma R&D and CMC Design & Development quality objectives supporting CMC and device aspects of clinical development phase pre-Phase 1 and up to Market Authorization Application and initial product launch
- Lead and manage the CMC Design & Development Quality Network
- Secure data driven compliance decisions supported by other relevant information (e.g. industry best practices)
- Coordinate and support Health Authority inspections and internal and external audits
- Initiate and coordinate QMR preparations and support presentations
- Quality Data reporting
- Train and advice colleagues in relevant quality systems and coordinate Annual GxP training
- Super user of MyQMS (Veeva Vault) and platform user of Power BI
- Super user and advisor on compliance processes (e.g. Change Control, Non-Conformancies, SOP authoring and review)
- Secure close collaboration with LEO Pharma Development Quality organisation
- Simplify and increase the efficiency of SOP training of employees in the CMC D&D organisation
- Be a sparring partner for Line of Business Managers and Subject Matter Experts in writing quality documentation to the projects
You will work across the expanding CMC Design & Development organisation as well as with internal stakeholders in Global Quality, Global Product Supply and External Manufacturing and occasionally with external stakeholders (CRO/CMO or Partners) and be in contact with colleagues in various departments and functions.
About the Area
The CMC & Device Project Management and Business Support Area is a central part of the newly formed matrix organisation in the CMC Design & Development VP Area. The VP Area spans six Director Areas, working with API, formulation, analytical methods, devices and exploratory activities within combination products, biopharmaceuticals, small molecules, topicals and systemics, with a total of app. 160 dedicated colleagues.
Your new job role will be in reference to the Director of the newly established CMC & Device Project Management and Business Support Area, where you will join nine other highly skilled, helpful and engaged strategic business support colleagues and CMC & Device Project Managers.
The Area is established to provide CMC and Device Project Management for clinical development candidates and secure cross-organisational, strategic business support in support of LEO Pharma´s R&D 2030 strategy. We will build our organization together, bringing in best practices from own experience and other organisations while we simultaneously secure support and guidance to our colleagues and stakeholders.
Your qualifications
- Broad knowledge gained from working a number of years within several relevant fields of expertise, e.g. combination products, biopharmaceuticals, devices or small molecules and in CRO/CMO or Partner relations
- Strong understanding of combination products, (bio)pharmaceutical and/or medical device value stream
- Ability to include different perspectives through professional standard knowledge of areas across CMC Design & Development functions and clinical development phases
- Experiences with leading different types of projects and initiatives and with working in a matrix organization across cultures and time zones.
- Relevant formal GxP training and knowledge of Quality related principles and practices.
- Strong coordinating capabilities in combination with leadership abilities (e.g. set Quality strategy for the Area, ensure activity progress by holding Compliance Network members accountable, motivate, challenge and create a collaborative spirit, influence and impact without direct authority)
- Ability to take ownership of maintaining own necessary training and professional development
- Team-orientated and able work collaboratively with all organizational stakeholders
- Strong can-do attitude and with ability to provide hands-on documentation assistance if needed
What we provide:
By joining CMC & Device Project Management and Business Support you will have a unique opportunity for joining and forming a growing organisation and for designing and impacting business critical quality processes in a large VP Area. You will join a newly formed unit with a positive, constructive and helpful environment with highly skilled, engaged and caring colleagues and bringing new treatment to patients suffering skin conditions world-wide.
Interested?Please contact Director Pernille C. Svane +45 31 34 76 01 for more information. We look forward to receiving your application.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 11.6.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktspecialist
- Ballerup
- Søndag den 26. september 2021
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