SUMMARY

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.

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%

• 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,