Manager / Sr. Manager, Clinical Manufacturing QA -

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 Manager / Sr. Manager Clinical Manufacturing QA - Small Molecule. This role provides the QA leadership and oversight on GMP operations related to clinical manufacturing for the project he/she is in charge of. He/She also ensures appropriate use and improvements Quality Management Systems related to small molecule products during clinical development (prior to commercialization). The Senior Manager ensures that manufacturing and testing of small molecule products are performed in compliance with GMP requirements, regulatory submissions and Incyte's procedures.
Essential Functions of the Job (Key responsibilities)
Ensure QA leadership and oversight for managing small molecule products.
Implement, perform, and maintain Quality Systems and procedures, provide input for improvements when deemed necessary,
Support implementation and promote use of Incyte Quality Management Systems and Global Policies,
Develop, implement and maintain Incyte procedures related to Her/his area of responsibilities.
Act as a Key User of internal eDMS / eQMS and provide advise and/or training when needed,
Assesses CMO's Quality risk levels and ensures mitigation of risks,
Leads the development of QTA (Quality Technical Agreement) templates and ensures establishment and maintenance of QTAs with concerned CMOs.
Acts as QA Representative for Business Reviews Program with CMOs to ensure sustained compliance and performance,
Perform QA duties and ensure QA oversight during management of supplier quality events including deviations, OOS, investigations, change controls, CAPAs and complaints related to clinical development projects.
Leads Quality Business Review Meetings with CMOs as Incyte representative,
Perform internal and external cGMP audits, ensure review and approval of the auditee response and follow-up on CAPA when applicable,
Responsible for suppliers GMP oversight per Incyte's procedures.
Drives the resolution of major Quality issues,
Reviews and approves internal and external deviations, OOS, OOT and related investigations,
Ensures implementation of internal and external change controls,
Ensures implementation of internal and external CAPAs,
Perform QA role during management of internal Quality Events records in Veeva including audits, deviations, CAPAs and change controls as needed,
Quality review of stability data for clinical stage products,
Approve supplier GMP documents including, but not limited to master batch records, specifications, test procedures,
Manages and organizes the batch disposition activities across assigned clinical products to ensure compliance and timely supply of products, Decides on Product batch disposition for the assigned products,
Review Regulatory documentation, such as NDAs, INDs and IMPD, as well as responses to Health Authority questions as needed,
Collect, report and maintain Quality Management System metrics associated with his/her responsibilities,
Manage and track controlled documents distribution to external CMO's, ensure consistency of shared version with applicable regulatory files
Ensures inspection readiness at assigned CMOs for product related inspections.
Identify & alert QA Management of internal and external quality system and product issues.
Cooperates with the IMSC Supply Chain, RA-CMC, Analytical and Manufacturing Development in matters relating to assigned clinical Products,
Collaborate with QA Validation and Commercial Manufacturing QA to ensure smooth handover of projects QA ovesrsight from clinical stage to validation stage.
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 managing GMP operations related to small molecule products.
Experienced with CMO relationship/Quality... For full info follow application link.

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Job Posting: 1049751

Posted On: Sep 30, 2022

Updated On: Oct 30, 2022