Job ID: 13363
Location: Summit, NJ
Full/Part Time: Full-Time
Category: Quality Ops
Department: Corporate Quality & Compliance - 1106
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
Scope: This position provides quality oversight and a single and consistent quality approach for our Development and Commercial products globally throughout the product development and commercial lifecycle. The Quality Product Steward (QPS) position enables consistent and efficient communication and decision-making related to the quality of our products across the global supply chain to occur. The QPS acquires and applies product-quality knowledge and acts as the quality expert for assigned products throughout the product lifecycle.
- Bachelors Degree in engineering, chemistry or related life sciences field. Advanced degree is preferred.
- A minimum of 15 years related experience in a regulated industry, a minimum of 10 years in a GMP biotech and/or pharmaceutical environment.; minimum of 5 years related experience in pharmaceutical product development
Responsibilities include, but are not limited to, the following:
- Represents all of the Global Quality Operations functions on cross-functional project teams to enable quick and effective decision-making and to ensure that the quality of a product meets predefined quality and compliance requirements.
- Serves as the single point of contact in the Global Quality Operations organization for the development and post-approval lifecycle management of assigned products and leads product specific continuous improvement and change management initiatives
- Serves as the quality expert for the product during clinical development/commercial supply and is responsible for making strategic quality decisions.
- Serves as the quality and product expert for the product during the commercial lifecycle and is responsible for making quality-related decisions and playing the role of the liaison between the manufacturing / supply chain and other quality functions
- Provides a proactive front-end approach to product quality. Ensures quality and compliance are ingrained and built into the process during pharmaceutical development and commercial supply.
- Establishes and tracks product metrics, monitors overall product quality performance and the integrity and quality of the product supply chain, and initiates / leads improvement initiatives to enhance performance and/or mitigate quality or compliance risks
- Leads multi-site/multi-function risk management programs for assigned products and is accountable for the completion of risk mitigation activities
- Participates in and supports complex deviation investigations, Material Review Boards, Change Management, Specification Committee, critical quality complaint resolution activities for assigned products
- Leads the creation of the Annual Product Review / Product Quality Review and other product-specific quality documents as required. Support regulatory filings, inspections and compliance audits for assigned products.
- Creates and maintains product and process knowledge database and transfers knowledge to site and regional employees
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
- Demonstrated ability to effectively develop, communicate and gain support for strategic plans from wide range of stakeholders
- Hands-on knowledge of assigned product and related processes and technologies
- Global pharma operational experience and working knowledge of regulatory and operating requirements in a global setting
- Solid understanding of the overall drug development process (non-clinical, clinical, API, and final dosage form, commercial scale-up and launch, associated regulatory requirements)
- Hands-on knowledge of pharmaceutical product development, clinical supply, tech transfer, and scale-up processes
- Working knowledge of international GMP requirements and quality systems
- Demonstrated understanding of tools and approaches to assess and mitigate risk and to improve product quality
- Understanding of key performance indicators (KPIs) and operational metrics
- Demonstrated project management skills with a proactive approach to issue identification and resolution
- Ability to work effectively across functional groups and teams to ensure requirements are met
- Ability to make independent and objective decisions and to work with minimal supervision
- Well-developed analytical and problem-solving skills
- Solid interpersonal and collaborative skills. Must be a team player.
- Demonstrated ability to plan, organize, and drive improvement initiatives in a matrix environment
- Excellent written & oral communication skills
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.