Essential Functions of the Job (Key responsibilities)
- Senior point of contact for Quality matters as it relates to Incyte's business
- Ensure Inspection readiness programs are in place regulatory inspections are managed in the most effective way.
- Member of the Tech Ops Senior Management
- Accountable to identify, report and mitigate company Quality and GxP compliance risks and concerns.
- Define and implement the Incyte Quality standard for Incyte Corporation in line with US and International regulations.
- Participate in establishment of new partnerships and Business Development initiatives.
- Develop and maintain an environment of strong collaborations and partnership with GxP functions to achieve the Incyte objectives.
- Enable the Quality organization to perform effectively with sufficient Quality resources to support sustainable business growth.
- Lead and develop the Incyte Global Quality organization to continuously meet the Incyte Quality objectives.
- Foster an environment of continuous quality improvement
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Results focused which may require negotiating skills, empathy, diplomacy, common sense
- Proficiency in additional languages, such as French, is a valuable asset and can enhance our team's diversity and global reach;
- Strong verbal and written communication skills with well-structured communication and presentation ability; proficiency in English written and spoken (the company language), while valuing multilingual abilities;
- Experience in managing development, manufacturing, and distribution contractors. International exposure in positions interacting with and influencing site operations. Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements. Strong interpersonal skills, with an emphasis on collaboration and communication across diverse teams;
- Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering); Significant experience in QA for international pharmaceutical and/or biotech industry; Thorough knowledge of GxP and global regulatory requirements;
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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