What are the responsibilities and job description for the Senior Manager, QA Biologics & Combination Products Manufacturing position at 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 Senior Manager, Quality Assurance (QA) provides oversight for biological and combination products from clinical development through commercial manufacturing. This position ensures that manufacturing, packaging, labeling, and testing operations are performed in compliance with GMP requirements, regulatory submissions, and Incyte's Global Quality standards and procedures. The Senior Manager serves as a key quality partner to internal and external stakeholders, supporting the advancement of Incyte's biologics and combination product portfolio throughout the product lifecycle.
Essential Functions of the Job (Key responsibilities)
* Provide QA leadership and oversight for biologics and combination products across both clinical and commercial stages of development and manufacturing.
* Support the execution and integration of Incyte's Quality Management Systems (QMS), ensuring consistent application across product lines and manufacturing sites.
* Serve as the primary QA representative for internal and external partners, providing input on quality and operational decisions.
* Review and approve critical GMP documents such as master batch records, specifications, test procedures, and reports.
* Support process validation and transportation qualification activities.
* Review and disposition executed cell bank, drug substance and drug product batches for biologics and combination products in both clinical and commercial stages.
* Provide oversight of supplier and contract manufacturing organization (CMO) quality performance, including Quality Agreement negotiation, supplier qualification, and ongoing compliance monitoring.
* Lead internal and external cGMP audits to ensure compliance and drive continuous improvement.
* Lead QA management of supplier quality events, including investigations, change controls, CAPAs, and complaints, ensuring timely closure and effective root cause analysis.
* Manage internal Quality Events (deviations, CAPAs, continuous improvement, and change controls) in Veeva QMS and ensure adherence to procedural timelines.
* Identify, escalate, and assist in resolving internal and external quality system issues, driving robust corrective and preventive actions.
* Review and contribute to regulatory submissions (INDs, IMPDs, BLAs) and responses to Health Authority inquiries as needed.
* QA lead for Design History File (DHF) preparation and / or Product Specification File (PSF) as applicable.
* Support Incyte combination product quality system procedures review and approval.
* Monitor and report key Quality System metrics and identify trends or risks that require management attention.
* Oversee controlled document management and distribution to external partners and CMOs.
* Coordinate the collection of APQR/YBPR data and lead the issuance of Incyte Annual Product Quality Reviews for the assigned Commercial products.
Qualifications (Minimal acceptable level of education, work experience, and competency)
* Degree (such as Bachelor's, Master's, or Ph.D.)in a scientific or engineering discipline (e.g., Pharmacy, Chemistry, Biotechnology, or related field), or equivalent relevant experience.
* Typically requires 5-7 years of relevant experience in the pharmaceutical or biopharmaceutical industry, with at least 5 years in a GMP quality or regulatory function, or the equivalent combination of education, training, and experience.
* Proven experience in managing GMP operations and quality oversight for biological and combination products throughout clinical development and commercial manufacturing.
* Sound awareness and understanding of the pharmaceutical business, especially with regards to quality and international regulatory requirements (including but not limited to US, EU, CH, MHRA, CA, JP).
* Demonstrated leadership in managing CMO/partner quality relationships, including audits, investigations, and performance governance.
* Strong problem-solving skills with the ability to make sound quality and compliance decisions.
* Excellent organizational, project management, and interpersonal skills, with the ability to lead cross-functional quality initiatives, fostering an inclusive environment.
* Strong written and verbal communication skills, including experience collaborating with Health Authorities and senior management.
* Ability to travel 15-20% or more as required, both domestic and international, with reasonable accommodation made for qualified individuals with disabilities.
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.
