Manager, Global Quality Systems - Global Change Management - 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.
1. PURPOSE AND SCOPE OF POSITION:
The Manager, Global Quality Systems – GCM, is responsible for process and system ownership of the Global Change Management (GCM) quality system element. In this role, the incumbent will serve as business process owner for the eQRMS electronic change management module and associated governing procedures for both the commercial and developmental space. 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 requiring both strategic and tactical decision making. In this capacity, the Manager will be the primary subject matter expert for GMP change control across the company.
2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Must have expert GMP, Quality, and in-depth risk management knowledge, particularly in the area of GMP Change Control.
- Must have an operational knowledge, including life cycle management experience, of common electronic quality system platforms, preferably EtQ, Documentum, and ComplianceWire.
- Must complete tasks independently and be confident in making complex decisions in their subject matter area, consulting with supervisor for decisions outside of established processes.
- Will Interact with and influences across multiple departments and sites.
- Shall lead Global Site Lead team and drives performance and results.
- Must be able to conceptualize broad impact of system related initiatives and recognize quality issues.
- Must be a problem solver, actively seeking management guidance on complex issues.
- Shall be able to effectively prepare communications to the customers and management in a productive manner with clarity, brevity, and accuracy.
- Must be familiar with the roles and responsibilities of common GMP functional areas such as Quality, Pharmaceutical Development, Regulatory Affairs and CMC, Technical Operations and Manufacturing.
- Must be action-oriented and customer-focused and skilled in the following areas:
- relationship building
- problem solving and negotiation
- conflict management
- analytical thinking
- Must have a thorough knowledge of PC productivity tools such as Word, Excel, PowerPoint, and Visio
3. DUTIES AND RESPONSIBILITIES
- Function as the Quality System Owner for the GCM 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 GCM system in both the Commercial and Development areas.
- Develop and conduct user training and manage system access.
- Provide input to and execute the strategic roadmap for the electronic GCM module in eQRMS.
- Represent GCM as SME and process owner in a front-room capacity during all internal and third party audits/inspections.
- Create and distribute all metrics, analytics and performance indicators for GCM.
- Collaborate with cross-functional system partners and represent the GCM user community in all governance and life-cycle related capacities.
- Own and implement a consistent and effective document hierarchy plan for the GCM system, including local and global elements.
4. EDUCATION AND EXPERIENCE
Relevant college or university degree in a scientific and/or clinical area of study preferred. Minimum 7 years relevant work experience and minimum 3 years of leadership experience; equivalent combination of education and experience acceptable.
5. WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
6. DEFINITIONS AND ABBREVIATIONS (As Applicable)
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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.