Global Compliance Director

Location
Pleasanton, CA
Salary
Competitive
Posted
March 22 2017
Ref
45998BR
Position Type
Full Time
Job Description

Job Title: Global Compliance Director
Requisition ID: 45998BR

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals

Responsibilities:

  • Maintain awareness of applicable standards and regulations, and monitor activities related to change to the standards and regulation.
  • Stay abreast of all upcoming changes to Product Safety and Compliance regulations and standards to ensure the organization is meeting all current requirements for new and legacy products.
  • Assess product regulations and standards impact to meet global requirements
  • Provide leadership to sites to ensure global product compliance requirements are understood.
  • Advise Divisional and BU leadership teams regarding strategies related to new and changing regulations and standards, including assessment of business compliance risk
  • Work closely with new product introduction teams to meet compliance requirements on schedule
  • Ensure all necessary compliance documentation is current and available upon request.
  • Oversee the operations of the design compliance group to ensure accurate results, adherence to Company protocols, and timely completion of projects.
  • Interface with corporate partners regarding quality issues, audits, and special projects.
  • Provide guidance to Manufacturing regarding quality and cGMP issues to ensure compliance with regulated standards.
  • Prepare and/or review documentation required for regulatory submissions.
  • Maintain metrics for the QC function and continuously improve the area in terms of quality, efficiency and effectiveness.
  • Actively lead initiatives toward continuous development, training, mentoring and/or coaching of staff in the Quality Control organization.
  • Lead the group of approximately 20 people to meet corporate goals.
  • This position is responsible for other duties as assigned


Minimum Qualifications:
  • Bachelor's degree in a Technical or Engineering discipline required.
  • Experience implementing Design for Compliance and training programs.
  • Experience in Cell Biology/Cell Therapy
  • Experience with Lab/ IVD/ Medical equipment is preferred.
  • Excellent interpersonal and communication skills with ability to effective interface with technical personnel at various levels of the organization.
  • Ten (or more) years of progressive professional experience, with a minimum of 5 years in management within pharmaceutical Quality Control.
  • Strong knowledge of regulatory guidelines and their application.
  • Excellent written and verbal communication skills.
  • Ability to act quickly and decisively.




At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.


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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.