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.
Our Global Quality Assurance Group is looking for a Director, Clinical Manufacturing QA, Small Molecule. The Director leads QA group responsible for supporting GMP operations for small molecule projects during clinical development. Responsible for development, implementation of Incyte procedures and ensures compliance with Incyte Quality Systems as it applies to small molecule products during clinical development stage.
Lead, mentor and manage QA team within Clinical Manufacturing QA - Small Molecule group.
Ensure timely and efficient support of internal and external Quality Systems records (Deviations, Change Controls, Complaints, CAPAs).
Plan and manage group resources to implement GMP initiatives and provide effective QA oversight of GMP operations.
Accountable for managing team's projects and workload to ensure timely completion of teams assignments and objectives.
Act as quality lead for developing and maintaining a strong collaboration with Incyte cross-functional teams and external partners.
Ensure appropriate procedures supporting manufacturing, testing and process development for small molecule products are in place and followed.
Ensure inspection readiness for regulatory visits including hosting audits, management of inspections/rooms and responses to regulatory agency observations.
Support development and implementation of Incyte's Quality Systems.
Develop and perform GMP training.
Lead internal and external cGMP and GDP audits as required.
Review regulatory submission s such as IND, IMPD and NDA as well as responses to Healthy Authority questions.
Drive and monitor Quality issues related to GMP operations to resolution within the company and with external parties.
Stay abreast with the most current GMP regulations and guidelines.
Define and follow-up standard quality metrics and review quality indicators with recommendation for actions for improvement.
Notify Sr. Management of internal and external quality and compliance issues in a timely manner.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor's degree in scientific/life-sciences or related field.
Minimum of 7 years of experience in the Pharmaceutical or Biopharmaceutical industry with at least 5 or more years' experience in an FDA quality/regulatory related function required.
Thorough understanding of quality management systems and quality system practices in the pharmaceutical industry.
Extensive knowledge of small molecule drug substance and drug product analytical and manufacturing operations.
Proven experience in managing and mentoring highly active and dynamic team.
Experience with oversight of GMP operations performed at third party sites.
Experience with an EDMS, Training and Quality Management System.
Organized, detail-oriented with focus on quality of work.
Ability to manage and prioritize projects under tight timelines
Strong written, oral communication, interpersonal, and organization skills.
Strong computer skills including knowledge and experience using Microsoft applications including Excel, Word, and PowerPoint.
Ability to travel 15-20% or more as needed.
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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