Manager, QA Biologics Manufacturing

Role Summary

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 assigned products (Biologics and Combination Products as applicable). The role participates in transferring biologic compounds from development to commercial phases in collaboration with internal and external stakeholders, and ensures compliance of assigned registered products throughout their lifecycle with cGMP requirements and registration files.

• 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.
• Ensures that appropriate Quality Risk Management is in place for early identification of risks related to product quality, safety, and GMP compliance of the assigned CMO.
• Ensures escalation of relevant quality issues or concerns and contributes to the definition and implementation of relevant mitigation plans.
• Interprets GMP, general regulatory requirements, and quality systems regulations in the area of manufacturing and ensured implementation as applicable.
• Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
• Stays current with the applicable regulations and promote Quality across the Incyte organization.

• 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.

• 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.

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