at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
We are looking for a motivated individual to lead our global Quality Assurance group. This executive position will lead Incyte's Global QA organization and provide strategic Quality leadership across the corporation for Quality, GLP, GCP, GMP and GDP.
This leadership role is responsible for promoting Quality, GxP awareness and continuous improvement across Incyte. The position will ensure Quality and GxP compliance to Incyte requirements and external regulations and standards for Incyte's pharmaceutical business in the area of pre-clinical, clinical, manufacturing, supply and distribution operations.
Duties and Responsibilities
Lead and develop the Incyte Global Quality organization to continuously meet the Incyte Quality objectives.
Enable the Quality organization to perform effectively with adequate Quality resources to support long term business growth.
Develop and maintain an environment of strong collaborations and partnership with GxP functions to achieve the Incyte objectives.
Participate in establishment of new partnerships and Business Development initiatives.
Define and implement the Incyte Quality standard for Incyte Corporation in line with US and International regulations.
Accountable to identify, report and mitigate company Quality and GxP compliance risks and concerns.
Member of the Tech Ops senior Management
Ensure Inspection readiness programs are in place regulatory inspections are managed in the most effective way.
Senior point of contact for Quality matters as it relates to Incyte's business
Foster an environment of continuous quality improvement
Bachelor's degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering);
Firsthand experience of min 15 years in QA for international pharmaceutical and/or biotech industry;
Thorough knowledge of GxP and global regulatory requirements;
Experience in managing development, 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
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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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.