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Senior Director, Global Manufacturing & Distributi

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

SUMMARY

This position will lead and manage Incyte's Global Manufacturing & Distribution QA organization and provide strategic leadership across the Technical Operations product portfolio for Quality and compliance to Incyte and regulatory standards.

This leadership role is responsible for promoting & implementing Quality assurance over operations related to manufacture, testing and supply of drug substance, drug product and Finished Products destined for clinical and commercial use.

The Senior Director is a member of the Quality Leadership Team and promotes Quality, GxP awareness and continuous improvement across Incyte.

KEY RESPONSABILITIES

The Senior Director, will be responsible for:

 

Managing and developing the Incyte Global Manufacturing & Distribution QA Operations group

 

Developing the functional objectives in line with the business

 

The implementation and management of an effective Quality oversight of the Incyte global product manufacturing, supply and distribution operations, including management of associated changes, deviations, complaints as well as the planning of disposition and regional QP certification activities

 

Ensure Product disposition is performed in line with procedures and business timelines for supply continuity.

 

Ensure internal and external serious quality issues are driven to resolution

 

Responsible for informing Senior/Executive management of compliance or quality risks and concerns.

 

Represent QA function for introduction of new manufacturing and distribution business initiatives including due diligence activities

 

Lead QA Operations in support of new product launches and new markets

 

Develop and implement the risk based vendor Quality management program for Technical Operations and ensure maintenance of Quality agreements with suppliers

 

Ensure GMP/GDP audit programs are developed, implemented and monitored.

 

Partner with the Quality System and Development Quality functions to develop and maintain the Incyte Global Quality Management System and Quality improvement programs

 

Ensure Incyte sites, CMOs, contract labs, 3 PLs inspection readiness for product related inspections

 

Oversee Product Recall Operations

 

Define key Technical Operations Quality metrics and perform periodic GMP/GDP Quality Management Reviews

 

Ensure implementation of new regulations and requirements across technical operations as applicable,

 

Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements

 

Stay current with the applicable regulations and promote Quality across the Incyte organization

 

Lead, motivate and develop on-going competencies of the global Manufacturing & Distribution QA team of Quality professionals.

 

Effectively organize resources to support long term business growth in line with Incyte's requirements and external regulations and standards.

 

Lead QA contact and partner for Technical Operations Management including developing and maintaining strong collaborations with individual Technical Operations functions.

 

Define and implement the GMP/GDP quality standard for Incyte Corporation including alignment of policies and procedures with US and International regulations.

 

Ensure business and compliance timelines associated with QA operational tasks are met.

 

Standing member of Incyte's Quality Leadership Team.

 

Point of contact with Health Authorities for Quality matters in collaboration with RA

 

Initiate and implement continuous quality improvement programs

 

Ensure Quality risk management principles are applied within technical operations.

REQUIREMENTS

 

Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering);

 

Firsthand experience of min 15 years in Quality Assurance for international pharmaceutical and/or biotech industry with at least 7 years in leadership global roles.

 

Thorough knowledge in US, EU, ICH GMP and global regulatory requirements;

 

Experience in managing manufacturing and distribution contractors

 

International exposure in positions interacting with and influencing sites operations;

 

Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements;

 

Strong Interpersonal skills;

 

Strong verbal and written communication skills with well-structured communication and presentation ability;

 

English fluency written and spoken (the company language);

 

Knowledge of other languages such as French is an asset;

 

Results... For full info follow application link.

 

We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.        

        

 

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Job Posting: 821949

Posted On: Jul 12, 2021

Updated On: Aug 11, 2021