Director, Global Quality Systems - United States
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.
PURPOSE AND SCOPE OF POSITION:
This position is responsible to direct the personnel and activities of the Global Quality SystemsDepartment. Primary department activities include ownership of the Enterprise Laboratory Systems and Oracle Quality Module. The position has accountability for decisions regarding systemcompliance including design, implementation and continuous improvement and is responsible for development of applicable processes and procedures.
DUTIES AND RESPONSIBILITIES:
Global Quality Business Owner for Oracle ERP Quality Module and Enterprise Laboratory Systems
- Responsible for identification and implementation of best quality and compliance practices related to Oracle ERP Quality Module and Enterprise Laboratory Systems globally across multiple sites.
- Leads implementation teams, ensuring projects are delivered on time and within budget.
- Assures that periodic enhancements, upgrades and continuous improvement activities for Oracle ERP Quality Module and Enterprise Laboratory Systems meet requirements of the stakeholders utilizing the systems.
- Assures development and maintenance of applicable global Quality SOPs and Work Practices, compliant with applicable regulations and industry best practices.
- Prepares business cases supporting system implementation or enhancement. Secures the necessary funding for projects. Socializes projects to ensure support of stakeholders, ensures efficient utilization of resources.
- Collaborate with cross functional teams to ensure new and emerging process and data needs are identified and planned for on the ERP Technology Roadmap.
- Collaborate with Oracle and Laboratory site and functional leads and Global GMP Training to ensure robust Oracle and Enterprise Laboratory Systems training programs and curricula for GMP processes; Maintain Oracle and Enterprise Laboratory Systems Role Mapping.
- Liaise with internal Celgene IT and external system vendors on topics related to system performance, security access, upgrades and planning.
- Facilitate communications and activities to issue identification and resolutions
- Direct human resources including establishing staffing needs, interviewing and selection, organizational development, training, managing resources, mentoring, coaching and counseling and the performance management and compensation processes.
- Establish and oversee the department’s budget and analyze and recommend capital expenditures for technology and equipment.
- Lead assessment, continuous improvement and harmonization initiatives as needed and as assigned by senior leadership.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Must have expert GMP, Quality, and risk management knowledge that impacts the department or global function.
- Must be able to critically interpret problems and effectively communicate in an impactful manner to management, the group, and the broader organization with clarity and a high level of brevity and accuracy.
- Must be a technical/scientific expert. Must be able to measure technical/scientific attributes in qualitative ways and drive science based decisions across the organization.
- Must manage technical teams across the organization.
- Must have expert authorship of technical documents. Must be able to recognize the impact beyond a single project or collaboration.
- Must be skilled in strategic thinking, managing through systems, navigating politics, innovation management, and negotiation. Must possess a strategic perspective, leading vision and values, global acumen, and leadership disposition.
EDUCATION AND EXPERIENCE:
- Relevant college or university degree required; advanced degree preferred.
- Bachelor of Science degree in a science or technical field
- 12 or greater years of experience in the pharmaceutical industry
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.