SUMMARY
The Manager Commercial QA Packaging & Distribution will be responsible for the Quality oversight of commercial product distribution activities in EU, Swiss and UK markets. He/she will ultimately ensure that commercial products are distributed to end-customers in compliance with Incyte Quality standards and regulations.
He/She will oversee commercial packaging activities conducted at EU CMOs as well as the distribution at Third Party Logistics (3PLs) / Distributors.
DUTIES AND RESPONSABILITIES
Provide QA support for country launches and oversee related Change Controls.
Manage the Incyte Distribution network in line with regional scope as it pertains to Quality aspects and in compliance with GDP regulations.
Develop, negotiate and maintain Quality Agreements in line with regional scope.
Monitor contractors’ quality performance by defining metrics with periodic reporting.
Organize and chair Quality Business Reviews with packaging CMOs and key 3PLs/Distributors.
Be a Packaging Committee chair in line with regional scope.
Support the redaction of Annual Product Quality Reviews reports.
Oversee the change control process for Product distribution activities.
Manage secondary packaging activities at CMOs.
Perform batch disposition for finished products and coordinate with QP/RP for final release.
Manage Product returns and associated process.
Record, assess and reconcile Product Quality Complaints.
Be the QA lead for investigation for deviations within regional scope.
Chair Management Review Boards for major and critical product distribution issues in the region.
Support (mock) recalls execution and follow-up.
Develop, maintain and roll-out SOPs in line with scope of activities.
Perform audits according to Incyte audit program.
Perform all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
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
Thorough knowledge in cGMP and GDP and global regulatory requirements
Qualified auditor with proven experience in GMP/GDP audits
Experience in packaging operations and associated regulations
Strong interpersonal skills
Strong verbal and written communication skills
English fluency written and spoken (the company language)
Travel up to 15%
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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