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 Sr. Manager, Quality Operations. The Quality Management Senior Manager supports Clinical Manufacturing QA group in maintaining Regulatory Compliance and Quality Systems related to GMP operations for clinical projects. The position ensures GxP Quality Systems are developed, maintained and executed in accordance with Incyte standards and Regulatory requirements.
Essential Functions of the Job (Key responsibilities)
Assist with configuration, testing, implementation and maintenance of Incyte's Quality Management System.
Implement and manage Clinical Quality Management Systems, mainly for Deviations, CAPAs, Change Controls, Quality Agreements, Complaints, training and Audits.
Represent QA for implementation of non-compound specific Continuous Improvement Initiatives such as Supplier Relationship Management.
Lead Clinical Manufacturing QA Quality Management Review functions within Global QA and Business Partner.
Provide training on GMPs and the Quality Management System as needed.
Support cross-functional GxP audits and activities as required. Perform and Participate in internal and external cGxP audits as required.
Accountable for entry of Quality Management System-related information into applicable logs and system, both manual and electronic.
Collect, analyze and report Clinical Manufacturing QA Key Performance Indicators (KPIs) and metrics.
Track status and routing of Clinical Manufacturing Quality Systems documents: SOP's, Deviations, Complaints, Change Requests, CAPA's to ensure proper and timely implementation of assigned tasks and open action items.
Track status of review and approval of Quality Agreements and ensure timely revision of existing
Collaborate with Global QA to manage and maintain Incyte's GMP Approved Vendors List and Annual Audit Plan.
Draft and approve Standard Operating Procedures related to GMP/GDP operations.
Support preparing and hosting of inspections by regulatory authorities as needed.
Support and promote continuous improvement and quality culture.
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.
Understanding of quality management systems and quality system practices in the pharmaceutical industry. Experienced with Quality System management preferred.
Experience with an eDMS, eQMS, Training and Quality Management System.
Strong attention to detail.
Ability to manage and prioritize projects under tight deadlines.
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%.
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.