Overview:
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.
Sr. Specialist, Clinical Supplies QA
Job Summary (Primary function) |
The Senior Quality Specialist supports GMP Quality Assurance (QA) in maintaining Quality Systems related to clinical development, manufacture, testing and packaging of clinical supplies and commercial product for large and small molecules. The Specialist ensures Quality Systems are maintained to Regulatory standards. |
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Essential Functions of the Job (Key responsibilities) |
- Manage QA responsibilities related to clinical packaging, labeling and QP Release.
- Disposition of packaging and labeling of supplies for clinical use.
- Review cGMP documentation related to the manufacturing of drug substance product, drug product, packaging, and labeling for clinical use.
- Manage the execution, review, and/or approval process of all controlled documents, including SOPs, deviations, investigations, change requests, CAPAs.
- Manage and track controlled document distributions to external CMO’s.
- Assist with management of Product Complaint Program life cycle (receipt, process, investigate, track and closure) including internal and external communications.
- Assist with maintaining Quality Systems and procedures.
- Assist with the notification, monitoring, and closure of internal and external investigations and complaints related to clinical supplies.
- A subject matter expert for Incyte's EDMS and Quality Management System to support clinical supplies.
- Manage CMO Quality relationships.
- Ensure compliance with Quality Agreements to packaging and labeling operations..
- Ensure timely routing and processing of all GxP documents.
- Review Regulatory documentation, such as INDs and IMPDs to support the release of clinical supplies.
- Support internal and external cGxP audits and activities as required.
- Provide support during regulatory agency inspections.
- Identify internal and external Quality System issues and alert QA supervision.
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Qualifications (Minimal acceptable level of education, work experience, and competency) |
- Bachelors of Science or equivalent work experience with minimum of 10 years of experience in the Pharmaceutical or Biopharmaceutical industry with at least 5 or more years' experience in an FDA quality/regulatory related function required.
- Knowledge of primary and secondary packaging configurations for global clinical studies.
- 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.
- 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%.
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Source : Incyte Corporation
