Associate Director QA release

SUMMARY

This Position will manage the QA release team for Incyte biological Drug Substance manufacturing facility at Yverdon-les-Bains, Switzerland. It will ultimately ensure that Drug Substances manufactured and tested at the BioPlant conform to the GMPs, the Specifications and regulatory filings.

In a context of rapid geographical expansion, he/she will develop processes and maintain strong collaboration with other global QA groups to ensure compliance of DS in all new territories.

With multiple tech transfers ahead, he/she will play a key role in setting QA strategies for an effective management of Tech transfer in the area of responsibility.

Responsibilities includes the QA oversight of QC activities, Raw materials and Drug Substance release.

The Associate Director will maintain a strong collaboration with other Bioplant and global functions and will promote continuous improvement and Quality culture.

The Associate Director will act as deputy QP, in accordance with Swiss regulations.

Duties And Responsabilities

• Manage the QA release team
• Act as QP delegate
• Lead the QA oversight of QC activities to ensure compliance of the QC laboratory, QC processes and methods, QC data
• Manage the Drug Substance batch release activity, including Release specifications management, batch disposition process
• Lead cross functional teams to ensure DS batches are released within defined timelines
• Responsible for the QA oversight of the Warehousing activities
• Manage the raw materials disposition activity including specifications management, raw materials disposition process
• QA lead for Tech transfer activities related to QC methods and raw materials qualification
• QA representative for the management of Contract Laboratories and third-party logistics centers
• Manage the BioPlant supplier Quality Management program
• Member of the Incyte Global Audit team (internal and external audits)
• Lead the Annual Product Quality Review Process
• QA lead to support regulatory Submissions
• Lead gap analyses to ensure compliance of QC activities and Raw materials with any new territories’ requirements
• Manage and Organize the activities to ensure compliance and timely supply of products
• Drive resolution of major quality issues
• Chair Management Review Boards and Change Review Boards for product related events
• Participate or lead continuous improvement projects
• Lead or contribute to the elaboration of risk assessments
• Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by Bioplant employees
• Ensure regulatory inspection readiness in area of responsibilities
• Support any Heath Authorities inspections (Swissmedic, FDA and other International Health Authorities) in relation to area of expertise and responsibilities
• Contribute positively to a strong culture of business integrity and ethics
• At all times work in a right first time and site inspection readiness approaches
• Act within compliance and legal requirements as well as within company guidelines

Delegation

• From Quality Assurance Director/QP BioPlant:
• Technical release of Bulk Drug Substances batches
• Review and approval of significant Changes, Deviations, Investigations and CAPAs
• Chair Quality Management Reviews
• Approval of Quality and Technical Agreement

To Quality Assurance BioPlant Management Team

• Review and approval of deviations
• Review and approval of change controls
• Review and approval of SOP, reports and other GMP documents

EXIGENCES

• Good speaking and reading skills in English and French
• Minimum of 10 years in a Quality Assurance role in a biopharmaceutical or related manufacturing environment
• Proven people management skills
• Thorough knowledge of biotechnology processes
• Demonstrated proficiency in good practice requirements cGMP as well as biopharmaceutical industry regulations
• Qualified auditor is preferred
• Proficiencies with the quality systems and with manufacturing processes
• Demonstrated experience in Health Authorities inspections
• Ability to make pragmatic and compliant decisions
• Strong problem solving skills
• Strong result orientation and committed team member
• Flexibility and ability to travel (10%)
• Excellent written and verbal communication skills.

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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