Manager Global Distribution QA

Overview

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.

DUTIES AND RESPONSIBILITIES

1. Manage the Incyte Distribution network in line with regional scope.
2. Represent QA for country launches and oversee related Change Controls.
3. Collaborate with Incyte commercial partners for submissions management.
4. Coordinate submissions preparations activities with Incyte QA manufacturing and Incyte CMOs.
5. Collect and maintain product submission data as well as country specific GMP accreditations for Incyte entities and partners.
6. Represent the QA function for the selection, approval and qualification of new suppliers in line with scope.
7. Maintain Quality Agreements up to date in line with the expansion plans.
8. Represent QA in Quality Business Reviews with key 3PLs/Distributors/Partners.
9. Chair Management Review Board for major and critical product distribution issues.
10. Be the QA lead for investigation for deviations within regional scope.
11. Perform batch disposition for finished products and coordinate with QP/RP for final release.
12. Record, assess and reconcile Product Quality Complaints.
13. Develop and provide on the job training on Batch Disposition, Deviation, Complaints and Change Control to new hires as per scope of expertise.
14. Perform audits as Lead Auditor according to Incyte audit program.
15. Perform all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
16. Continuously strive for process improvement in line with Quality Mission.
17. Stay current with the applicable International Regulations and promote Quality across the Incyte organization.
18. Contribute positively to a strong culture of business integrity and ethics.
19. Act within compliance and legal requirements as well as within company guidelines.

REQUIREMENTS

1. Academic degree in natural or applied sciences preferred.
2. Firsthand experience of min 8 years in the pharmaceutical and/or biotech industry preferably in Quality related roles and in market readiness activities.
3. Thorough knowledge in cGMP and GDP and global regulatory requirements.
4. Qualified auditor with proven experience in GMP/GDP audits is a plus.
5. Strong interpersonal skills.
6. Excellent verbal and written communication skills.
7. English fluency written and spoken (the company language).
8. Travel up to 15%.

DELEGATE: N/A

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.

#J-18808-Ljbffr