Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Sr. Manager, Global Quality Systems – QUADS, will play a critical role in the implementation and management of a best-in-class Quality Analytics and Decision Support System (QUADS). In this role, the incumbent will establish operational principles, procedures, and processes that deliver critical-to-quality information, data, and metrics, seamlessly and efficiently to senior leaders and key stakeholders. The Sr. Manager will serve as the primary point of contact for access and distribution of quality data and for business ownership of the technology solution. This position will assist in the planning and execution of the Global Quality Operations vision related to Quality data management, optimization, and analytics. Additionally, this position will have supervisory responsibility for a team of Quality Specialists dedicated to the maintenance and enhancement of the technology platform. This is a highly visible role with global responsibility and cross-functional influence that has a high impact on departmental performance and broad quality initiatives.
Responsibilities include, but are not limited to:
- Function as the Quality System Owner for the QUADS system and all associated processes and procedures.
- Plan and implement lifecycle changes and system level enhancements through partnership with IT Developers and Business Analysts.
- Author and maintain all standards, policies, procedures, work practices and job aides that support the QUADS system.
- Develop and conduct user training and manage system access.
- Provide input to and execute the strategic technology roadmap for the QUADS system.
- Represent QUADS as SME and process owner in a front-room capacity during all internal and third party audits/inspections.
- Collaborate with cross-functional GMP partners including but not limited to Technical Operations and Pharmaceutical Development to ensure new and emerging data needs are identified up-front and planned for on the system roadmap.
- Supervise quality professionals that perform life-cycle management tasks related to the QUADS system.
- Champion the utilization and standardization of analytical techniques including statistical tools and methodologies for testing, validation, trending, reporting, and sampling.
- Collaborate with 3rd party partners in the implementation and life-cycle management of the QUADS system.
- Must have expert GMP, Quality, and in-depth risk management knowledge.
- Must possess a strong operational knowledge of analytic and statistical tools and methodologies including visualization techniques.
- Must be familiar with traditional and advanced critical-to-quality metrics and analytics (compliance, performance, health, and diagnostic).
- Must have an operational knowledge, including life cycle management experience, of common electronic quality system platforms, preferably EtQ, Documentum, ComplianceWire, and Tableau.
- Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must be able to fully interpret complex results and situations independently and articulate recommendations for resolution. This includes the identification of critical risks and development and deployment of contingency plans.
- Must be able to develop and coach employees.
- Most have a strong technical writing skill set and be able to critically review reports while effectively inputting and expressing Quality risk management principles.
- Must be action-oriented and customer-focused and skilled in the following areas:
- building relationships
- problem solving
- conflict management
- planning and organizing
- resource allocation
- Analytical thinking.
- Must possess an independent mindset and tenacity.
- Must complete tasks independently, notify supervisor of decisions outside of established processes and the ability to build an internal network.
- Must be able to manage experienced professional employees.
- Must have a thorough knowledge of PC productivity tools such as Word, Excel, PowerPoint, and Visio. Expert knowledge in the utilization of Excel is preferred.
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. 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.