Manager, Global GMP/GDP Compliance
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.
PURPOSE AND SCOPE OF POSITION:
This position is responsible for developing, implementing and managing Global GMP/GDP compliance programs. This position manages, Quality Management Review, Emerging/Changing Regulation Process, and provides support during internal and health authority inspections of facilities and CSPs.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Must have expert GMP, Quality, and in-depth risk management knowledge;
- Must be able to effectively prepare communications with interpretation of data
- analysis and potential problems to management and the group with clarity and a high level of accuracy;
- Must be able to note technical/scientific attributes in potential situations or issues and process science based solutions across a majority of the job function;
- 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 have strong authorship 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 decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Must possess an independent mindset and tenacity;
- Completes routine tasks with no supervision; Confident in making non-routine decisions in their subject matter area; Able to work proactively. Drives continuous improvement and improves efficiency and productivity within the group or project;
- Leads cross functional project teams driving performance and results. Skilled at getting resources and information from internal and external contacts;
- Manages conflict and issues with internal and external customers. Able to recognize conflict and notify management with proposed recommendations for resolution; Builds and leverages relationships and provides advice internally within function and with global cross-functional teams. Negotiates solutions cross functionally;
DUTIES AND RESPONSIBILITIES:
Identify and implement best demonstrated quality and compliance practices and systems across multiple sites:
- Develop and implement global processes and systems;
- Work cross functionally to deploy throughout the organization;
- Ensure continuous improvement of quality systems and compliance processes.
Manage the global Management Review program to effectively monitor Celgene's quality systems at the global level and ensure continuous improvement:
- Create and maintain templates to capture data from global stakeholders;
- Analyze and interpret data; generate charts/graphs to communicate results and trends.
Manage global Emerging and Changing GMP/GDP Regulation and Guidance process:
- Maintain global procedure;
- Monitor emerging and changing GMP/GDP regulation and guidance documents for evaluation and comment;
- Manage evaluation documentation, comment documentation, and report completion.
Provide support during internal and health authority inspections of facilities and CSPs;
- Carry out plans and actions to support acquisitions, new product launches, product inlicense operations, new market and trading partner opportunities, and other quality management activities as assigned.
EDUCATION AND EXPERIENCE:
- Relevant college or university degree preferred. Equivalent combination of education and experience acceptable;
- 7-8 years of Pharmaceutical Experience;
- Experience with PC based office computers and standard Microsoft Office applications;
- Experience with SharePoint;
- Experience with electronic document and data management systems.
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.
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.
#LI-POSTCelgene 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.