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Sr. Manager, Clinical Manufacturing QA Biologics

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

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. QA Manager, Clinical Manufacturing QA Biologics. This position supports GMP operations and Quality Management Systems related to biological products during clinical development (prior to commercialization). The Senior Manager ensures that manufacturing; packaging and testing of biological products are performed in compliance with GMP requirements, regulatory submissions and Incyte's procedures.

Essential Functions of the Job (Key responsibilities)

Act as QA lead for managing biological products.

Develop, implement, perform, and maintain Quality Systems and procedures.

Support implementation of Incyte Quality Management Systems and Global Policies.

Develop, implement and maintain Incyte procedures.

Act as a knowledge manager of internal eDMS / eQMS and provide training when needed.

Perform internal and external cGMP audits.

Responsible for suppliers GMP oversight per Incyte's procedures.

Negotiate Quality Agreements with third parties.

Approve supplier GMP documents including, but not limited to master batch records, specifications, test procedures.

Review and disposition of suppliers executed drug substance and drug product batches intended for use in clinical studies during clinical development stage.

Perform QA duties during management of supplier quality events such as investigations, change controls, CAPAs and complaints related to clinical development projects.

Review Regulatory documentation, such as NDAs, INDs and IMPD, as well as responses to Health Authority questions as needed.

Report and maintain Quality Management System metrics associated with his/her responsibilities, as needed.

Manage and track controlled document distributions to external CMO's.

Perform QA role during management of internal Quality Events records in Veeva such as audits, deviations, CAPAs and change controls as needed.

Provide support and participate in regulatory agency inspections.

Identify & alert QA Management of internal and external quality system issues.

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

Bachelors degree in scientific/life-sciences or related field.

A minimum of 5-7 years experience in the Pharmaceutical or Biopharmaceutical industry with at least 5 or more years experience in an FDA quality/regulatory related function required.

Experience in GMP operations related to biological products.

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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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.        

        

 

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Job Posting: 879307

Posted On: Dec 02, 2021

Updated On: Jan 01, 2022