Job Summary (Primary function)
This position will provide support to the Global Distribution team in the area of Packaging & Distribution for Incyte Corporation. This individual will be responsible for complying with the quality requirements and standards for small and large molecule commercial products in a GMP regulated environment.
Essential Functions of the Job (Key responsibilities)
·Manage the Incyte Distribution network in line with regional scope.
·Provide the QA expertise and input for the conduct of Distribution Risk assessments in the assigned regions. Escalate the potential strategic risk through the GMP GDP Risk Management program and the MRB process.
·Record, assess and reconcile Product Quality Complaints while coordinate collection of additional information from external and internal stakeholders (i.e. patient, Pharmacies, etc).
·Develop, negotiate and maintain Quality Agreements in the assigned territories.
·Ensure compliance of Incyte Products by reviewing, approving and ensuring maintenance of Packaging & Shipment Specifications with new product introduction and product expansion.
·Develop, maintain and roll-out SOPs in line with scope of activities.
·Lead the resolution of Packaging & Distribution related change controls, CAPAs, deviations and logistic events.
·Lead Risk Management initiatives for the Distribution Network related to expansion of Incyte products.
·Develop and maintain a QA KPI dashboard for Packaging CMOs and Distribution.
·Lead the QA part in Quality Business Reviews performed with key 3PLs/Distributors and Partners.
·Chair Management Review Board for major and critical product distribution issues for assigned product(s).
·Coordinate complaint with Contract Manufacturers to ensure on-time closures of change controls, CAPAs & deviations.
·Complete review and approval of packaging component artworks and proofs review for existing and new product introductions for responsible markets.
·Cooperate with the US Supply Chain, CMC, QC and RA functions in matters relating to commercial Product.
·Manage and organize the batch disposition activities across commercial products to ensure compliance and timely supply of products.
·Support Annual Product Review issuance for assigned product(s).
·Support and lead the execution of mock recalls and continuously improve process as needed.
·Ensure on time issuance, assessment and close out of distribution related deviations & logistic events.
·Perform all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
·Stay current with applicable International Regulations and promote a Quality culture in all interactions both internally across Incyte organization and externally.
·Contribute positively to a strong culture of business integrity and ethics.
Qualifications (Minimal acceptable level of education, work experience, and competency)
·Bachelor’s degree, preferably in a scientific discipline, or 5 years’ experience in a pharmaceutical and/or biotech industry in Quality-related roles.
·Thorough knowledge of cGMP, GDP and global regulatory requirements.
·Ability to multitask and work both independently and within multi-disciplinary teams.
·Ability to critically appraise and apply GxP knowledge.
·Strong verbal and written communications skills.
·Strong interpersonal skills for effective professional communications, aiming to cultivate strong working relationships with both internal and external groups and to promote quality and GxP compliance.
·Travel up to 10%
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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