Manager, Clinical Manufacturing QA – Small Molecule - Incyte Corporation

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.

Job Summary (Primary function)
The QA Manager supports GMP Quality Assurance (QA) in maintaining Quality Systems related to clinical development including the manufacture and testing of clinical supplies for large and small molecules.  The Manager also ensures the control over the documentation required for regulatory submissions.

Essential Functions of the Job  (Key responsibilities)

• Develop, implement, perform, and maintain Quality Systems and procedures. 
• Act as a subject matter expert for Incyte's EDMS and Quality Management System.
• Provide training when needed on the EDMS and Quality Management System.
• Manage CMO Quality relationships.
• Attend and be an active participant in technical project team meetings.
• Review cGMP documentation related to the manufacturing of drug substance product, drug product, packaging, and labeling for clinical use.
• Manage the execution, review, and/or approval process of all controlled documents, including SOPs, deviations, investigations, change requests, CAPAs.
• Assist with the notification, monitoring, and closure of internal and third party investigations and complaints related to clinical supplies.
• Ensure timely routing and processing of all GxP documents.
• Disposition of drug substance, drug product, packaging, and labeling of supplies for clinical use.
• Accountable for entry of Quality Management System related information into applicable systems.
• Review Regulatory documentation, such as IND and IMPD, as well as responses to Health Authority questions if requested.
• Manage and track controlled document distributions to external CMO’s.
• Negotiate Quality Agreements with third parties. 
• Perform and support internal and external cGxP audits and activities as required.
• Provide support and participate in regulatory agency inspections.
• Identify internal and external Quality System issues and alert QA supervision.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Bachelor’s degree in scientific/life-sciences or related field.
• A minimum of 3-5 years of experience in the Pharmaceutical or Biopharmaceutical industry with at least 3 or more years of experience in an FDA quality/regulatory related function required.
• Thorough understanding of quality management systems and quality system practices in the pharmaceutical industry.  Experienced with CMO relationship/Quality System management preferred.
• Experience with an EDMS, Training and Quality Management System. Strong detail orientation and focus on quality work product.
• Ability to manage and prioritize projects under tight deadlines.
• Ability to work under challenging deadlines and be accountable for completing work within specified project 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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