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Manager, Biologics Manufacturing Quality Assurance

Incyte Corporation

Wilmington, Delaware

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JOB DETAILS
SKILLS
Alliance/Partner Management, Biotech and Pharmaceutical, CMOS, Candidate Screening, Change Control, Chemistry, Communication Skills, Continuous Improvement, Contract Manufacturing, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Data Processing, Data Quality, Documentation, External Audit, File Maintenance, GMP (Good Manufacturing Practices), Healthcare Quality, Information/Data Security (InfoSec), Internal Audit, Interpersonal Skills, Maintain Compliance, Manufacturing, Manufacturing Management, Multitasking, Negotiation Skills, Performance Analysis, Pharmacy, Presentation/Verbal Skills, Process Validation, Product Lifecycle, Product Management, Product Reviews, Product Testing, Project Lifecycle, Project Tracking, Project/Program Management, Quality Assurance, Quality Management, Regulatory Requirements, Regulatory Submissions, Standard Operating Procedures (SOP), Technical Writing, Testing, Time Management, Willing to Travel, Writing Skills
LOCATION
Wilmington, Delaware
POSTED
10 days ago
Overview:

The Manager, Biologics Manufacturing Quality Assurance (QA) is responsible for the Quality oversight of clinical and commercial manufacturing and testing activities performed at Contract Manufacturing Organizations (CMOs) for the assigned products (Biologics and Combination Products as applicable).  This role participates in the transfer of biologic compounds from the development phase to commercial in close collaboration with internal and external stakeholders. This role ensures compliance of assigned registered products throughout their lifecycle, with cGMP requirements and registration files and is responsible for assigned product quality management.

 

 

 

 

 

 

 

 

 

 

 

    Essential Functions of the Job 

  • Acts as a QA expert role for assigned biological and combination products as applicable.
  • Ensures full quality oversight of assigned Clinical and Commercial CMOs including compliance and performance monitoring.
  • Ensures quality oversight on assigned project lifecycle including development, process and methods validation/transfer, registration and commercialization.
  • Responsible for compliance of products by creating, approving and maintaining Product Specification files, product monographs and /or Design History File as applicable.
  • Decides on batch dispositions after comprehensive review of batch documentation.
  • For applicable markets, develops and maintains close partnership with Incyte QP/RP to ensure full support to batch confirmation and certification.
  • Maintains and controls the product batch records filling and databases.
  • Manages and approves internal and external deviations, OOS and related investigations, CAPAs and Change Controls in a timely manner.
  • Performs Quality review of stability data for products under their scope.
  • Coordinates the collection of APQR/YBPR data and leads the issuance of Incyte Annual Product Quality Reviews for the assigned commercial products.
  • Establishes and maintains Quality and Technical Agreements with assigned clinical and commercial CMOs.
  • Contributes to the maintenance of Incyte Quality Management System with a focus on the biological and combination products related SOP.
  • Supports the preparation of GMP applications in the REALM countries and APAC region.
  • Serves as a qualified auditor and performs external and internal audits according to Incyte audit program, reviews and approve responses, and ensures CAPA follow-up with relevant CMOs.
  • Provides QA support to the RA-CMC group for regulatory submissions and follow-ups.
  • Ensures inspection readiness plan implementation at assigned Commercial CMOs.

 

 Qualifications 

 

  • Degree (such as Bachelor’s, Master’s, or Ph.D.) in a scientific or engineering discipline such as Pharmacy, Chemistry, Biotechnology, or related field, or equivalent industry experience.
  • Firsthand experience of a minimum of 5 years in Quality Operations for pharmaceuticals.
  • Expertise in biotechnology products manufacturing and testing.
  • Experience in Contractor quality oversight.
  • Thorough knowledge of cGMP and US, EU, CH, MHRA, CA, JP regulatory requirements. Learning other GMP requirements might be necessary.
  • Demonstrated ability to write technical documents such as APQR.
  • Proven track record in project management as project team member, ability to contribute to multiple ongoing projects.
  • Knowledgeable of technical transfer requirements for Biologics and Combination Products.
  • Strong interpersonal skills.
  • Strong verbal and written communication skills with well-structured communication and presentation ability.
  • Results-focused which may require negotiating skills, empathy, diplomacy, common sense and continuous improvement.

Willingness to travel up to 20%, both domestic and international, with reasonable accommodations provided for individuals with disabilities or other needs.

 

 

 
 

 

 

 

 

 

 

 

 

 

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job.   You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. 

You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

 

 

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About the Company

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Incyte Corporation

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