Location: Seattle, Washington, United States
Job Category: Quality
Work Location: 400 Dexter Ave N. 98109
Organization: Quality Operations
Employee Status: Full-time
Job Type: Regular
Manager Global Product Quality
Celgene is seeking a manager within the Global Product Quality organization to oversee team members responsible for external QC operations at global contract test sites, product specification management activities, and stability study design and execution of Cell Therapy products. The ideal candidate will lead and influence both direct reports and global teams to ensure alignment across cell therapy programs relating to contract test site management, Quality system management of specifications and stability studies through change control and documentation management activities. The candidate will provide significant oversight and contributions to the daily operations of the Global Product Quality team, developing cross-program stability strategies, and will support regulatory filing activities to support clinical / commercial development. The position will be responsible for ensuring compliance with the current and prospective global regulatory requirements, and should be aware of and adopt effective and efficient industry standard practices.
REQUIRED COMPETENCIES; Knowledge, Skills and Abilities
- Must have a strong Quality mind-set with extensive knowledge of cGMP operations as well as general industry (ICH, USP, etc.) and health authority (FDA, EMA, PMDA, etc.) requirements for cell-therapy programs
- Knowledge of risk management principles and their implementation into routine production and/or testing strategies..
- Must be able to interpret problems and effectively communicate in a productive manner to management and teams.
- Must be able to evaluate technical/scientific attributes and drive compliant technical decisions.
- Must have strong troubleshooting skills and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality requirements.
- Strong technical writing skills
- Must manage problems of diverse scope and demonstrated ability to translate complex issues in a concise manner.
- Must be able to effectively operate and deliver in a continuously evolving regulatory and operations landscape.
DUTIES and RESPONSIBILITIES
- Leads a diverse team of individual contributors to support external QC operations at contract test sites, specification management, stability study management, and other Product Quality initiatives as needed.
- Collaborate within Quality, internal functional areas, and CMOs to generate, review and approve documentation, including: certificate of analysis, change controls, deviations, CAPAs and OOS/OOT investigation reports
- Develops, implements and continuously improves Quality Operations processes pertaining to quality oversight of contract testing laboratories, ensuring quality related items are tracked, monitored and resolved in a timely manner
- Oversee and perform cross-functional laboratory investigations related to stability and external laboratory operations
- Manage the operation of Stability programs across a multi-product portfolio, managing stability protocols and reports, coordination, review, reporting of stability test data for gene delivery and cell therapy drug products (internal reports, clinical / commercial regulatory filings).
- Performs document management responsibilities in support of gene delivery, intermediate, and drug product specifications. Supports the specification committee tactical execution as needed.
- Develops, monitors and reports on Product Quality functional responsibility and Key Performance Indicators including creation of dashboards and providing updates to management/leadership teams.
- Identifies quality issues and effectively and proactively communicates and resolves them in a diplomatic, flexible, and constructive manner
- Contribute to the preparation of CMC sections for clinical regulatory filings, MAA, and BLA
- Bachelors’ and/or Masters’ degree in scientific discipline with a technical understanding of biopharmaceutical production and understanding of cell therapy and drug product development and manufacturing
- Minimum of 10+ years of biologics industry experience in a technical role(s) supporting programs in pre-clinical phases through commercial, with at least one or more role (5+ years) in Quality (QA, QC and/or Compliance)
- Strong project management skills and ability to communicate effectively across matrix functions
- Strong knowledge of global regulations (EU, US) and GxP experience
- Excellent verbal and written communication skills
- Ability to prioritize and balance work from multiple projects in parallel
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.