This position will ultimately ensure that commercial products are distributed to end-customers in compliance with Incyte Quality standards and International requirements.
This position supports the Incyte global expansion by supporting product launches and establishment of new Distributorships.
Essential Functions of the Job (Key responsibilities)
Manage for Quality the Incyte Distribution network for all International markets (ex-US)
Provide QA support for new country launches, overseeing change control system, ensuring set-up of new shipping routes, approval of new distribution suppliers, implementation of artworks and conduct of mock launches
Develop, negotiate and maintain Quality Agreements with logistic partners
Support the set-up of new strategic commercial partnership for Incyte global expansion
Oversee the change control system for Product distribution
Monitor distribution contractors quality performance by defining set of metrics with periodic reporting and management review
Maintain a system to capture and monitor all applicable local regulatory requirements for product importation and distribution
QA lead for shipping validation activities and cold chain programs
Own the Global product Recall program for commercial products and ensure effectiveness of recall system
QA lead for the conduct of Distribution Risk Assessments, ensuring any distribution risks are mitigated
QA Management of change control for Product distribution activities
Support development of Annual Product Quality Reviews for product distribution related aspects
Represent the QA function in global anticounterfeiting and product security initiatives in collaboration with supply chains teams
QA lead for investigation of distribution related deviations and ensure implementation of CAPA at logistic centers
Manage Product returns
Chair Management Review Boards for major and critical product distribution issues
Develop, maintain and roll-out SOPs in line with scope of activities,
Perform audits according to Incyte audit program,
Ensure Incyte Biosciences GMP & GDP related process stay current with regulations,
Stay current with the applicable International Regulations and promote Quality across the Incyte organization,
Contribute positively to a strong culture of business integrity and ethics,
Act within compliance and legal requirements as well as within company guidelines.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Academic degree in natural or applied sciences preferred
Firsthand experience of min 8 years in the pharmaceutical and / or biotech industry preferably in Quality related roles
Thorough knowledge in cGMP and GDP and global regulatory requirements
Experience in dealing with Distribution Partners outside the EU and the US
Strong Interpersonal skills
Strong verbal and written communication skills with well-structured communication and presentation ability
English fluency written and spoken (the company language)
Knowledge of other languages such as French is an asset
Organized and results focused which may require negotiating skills, empathy, diplomacy, common sense
Disclaimer : The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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