Senior Director, Global Manufacturing & Distribution QA

Job content

Summary

This position will lead and manage Incytes 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 Incytes 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 Incytes 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 focused which may require negotiating skills, empathy, diplomacy, common sense
• Ability to travel domestically and internationally
  

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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Department: Global Quality Assurance Location: Incyte Biosciences Technical Operations Sàrl - Morges