Assoc Dir, Global GMP/GDP Compliance

Employer
Celgene
Location
Summit, NJ, US
Posted
Aug 04, 2018
Ref
1802652
Required Education
Bachelors Degree
Position Type
Full time
Other Locations:US- NJ- Summit West

Description

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 GMP/GDP compliance within Celgene. This position has accountability for decisions affecting quality compliance including Data Governance/Data Integrity, Global Quality Management Review and External Intelligence.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:
  • Must have expert GMP, Quality, and risk management knowledge;
  • Must be able to understand, interpret and communicate Data Governance and Data Integrity principles.
  • Must be able to critically interpret problems and effectively communicate in a productive manner to management, the group, and the broader organization with clarity and a high level of brevity and accuracy;
  • Must be able to recognize and group technical/scientific attributes in potential situations or issues and drive science based decisions across the function;
  • Must share information about current interpretations and application of regulatory expectations between the decision-maker and other stakeholders;
  • Must have expert authorship in technical documents. Must be able to critically interpret results and generate technical conclusions consistent with Quality risk principles;
  • Must have expert authorship in quality systems, investigations, and risk assessments. Must be able to critically interpret results and determine the desirability of new or additional content for GMP policies and standards, etc;
  • Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation. Must possess authenticity.


DUTIES AND RESPONSIBILITIES:
  • Responsible and accountable for the development, deployment and implementation of effective and efficient procedures and work practices governing global quality compliance in cooperation with regional and site functions;
  • Establish strategic direction and direct the development, implementation and execution of effective quality compliance programs to effectively monitor Celgene's compliance at the global level and ensure continuous improvement including global data governance/data integrity, quality management review and emerging/changing regulations;
  • Leading a cross-site team, support the development and compliance of a global Data Governance/Data Integrity program to include risk mitigation, training, communication and overall governance.
  • Develop plans and actions to assure the necessary steps are taken with quality compliance to support acquisitions, new product launches, product in-license operations, new market and trading partner opportunities, and other quality management activities;
  • Business Process Owner for Global Quality Management Review
  • Monitor external intelligence for regulatory and industry trends that may be impactful to organization.
  • Business Process Owner for Emerging/Changing Regulations. Manager process to ensure Quality System complies with current regulations in addition to providing comments on draft regulations.
  • 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;
  • Lead assessment, continuous improvement and harmonization initiatives as needed and as assigned by senior leadership;
  • Review and approve new and revised function SOPs to ensure compliance with cGMPs;
  • Provide support during internal and health authority inspections of facilities and CSPs;
  • Performs other tasks as assigned


EDUCATION AND EXPERIENCE:
  • Relevant college or university degree required; advanced degree preferred;
  • Bachelor of Science degree in a science or technical field;
  • 10-15 years of experience in the pharmaceutical industry;
  • Experience with PC based office computers and standard Microsoft Office applications;
  • Experience with SharePoint;
  • Experience with electronic document and data management systems.
  • An equivalent combination of education and experience may substitute.


WORKING CONDITIONS:

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.

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.