Manager Global Distribution QA at Incyte Corporation
1110 Morges, VD, Switzerland -
Full Time


Start Date

Immediate

Expiry Date

10 May, 25

Salary

0.0

Posted On

11 Feb, 25

Experience

8 year(s) or above

Remote Job

No

Telecommute

No

Sponsor Visa

No

Skills

Interpersonal Skills, Applied Sciences, Communication Skills, Regulatory Requirements

Industry

Pharmaceuticals

Description

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%
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,
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