at Incyte Corporation in Wilmington, Delaware, United States
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.
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.
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.
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