The Manager Commercial QA Packaging & Distribution is responsible for the Quality oversight of product distribution activities in multiple markets. He ultimately ensures that commercial products are distributed to end-customers in compliance with Incyte Quality standards and applicable regulations and GxP guidelines.
He / She oversees the Incyte distribution network in the assigned region. He / She is the QA lead for product launches and establishment of new distribution suppliers in the assigned region.
DUTIES AND RESPONSIBILITIES
* Manage the Incyte Distribution network in line with regional scope.
* Represent QA for country launches and oversee related Change Controls.
* Collaborate with Incyte commercial partners for submissions management.
* Coordinate submissions preparations activities with Incyte QA manufacturing and Incyte CMOs.
* Collect and maintain product submission data as well as country specific GMP accreditations for Incyte entities and partners.
* Represent the QA function for the selection, approval and qualification of new suppliers in line with scope.
* Maintain Quality Agreements up to date in line with the expansion plans.
* Represent QA in Quality Business Reviews with key 3PLs / Distributors / Partners.
* Chair Management Review Board for major and critical product distribution issues.
* Be the QA lead for investigation for deviations within regional scope.
* Perform batch disposition for finished products and coordinate with QP / RP for final release.
* Record, assess and reconcile Product Quality Complaints.
* Develop and provide on the job training on Batch Disposition, Deviation, Complaints and Change Control to new hires as per scope of expertise.
* Perform audits as Lead Auditor according to Incyte audit program.
* Perform all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
* Continuously strive for process improvement in line with Quality Mission.
* 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.
REQUIREMENTS
* 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 and in market readiness activities.
* Thorough knowledge in cGMP and GDP and global regulatory requirements.
* Qualified auditor with proven experience in GMP / GDP audits is a plus.
* Strong interpersonal skills.
* Excellent verbal and written communication skills.
* English fluency written and spoken (the company language).
* Travel up to 15%.
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