This job has expired and you can't apply for it anymore. Start a new search.
Thermo Fisher Scientific logo
Company Name:
Thermo Fisher Scientific
Approximate Salary:
Not Specified
Location:
Pleasanton, California
Country:
United States
Industry:
Position type:
Experience level:
Education level:

Director, Global Quality & Compliance

Job Description

Job Title: Director, Global Quality & Compliance
Requisition ID: 58136BR

Employer Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

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
  • Oversee the operations of the global distribution quality group to ensure compliant warehousing, distribution, and logistics practices.
  • Responsible for deployment and oversight of global Quality Management Systems. Manage a Key Opinion Leader (KOL) in QMS who drives QMS deployment and harmonization.
  • Drive improvements in global validation programs. Manage a KOL in Validation who leads the creation of validation tools, provides consultancy support to execution of validation programs, and enables harmonization of validation principles across LSG and the broader Employer organization.
  • Partner with the Global Field Service Engineering (FSE) organization to maintain oversight on all field activities. Direct a leader in quality responsible for oversight of the FSE organization.
  • Provide matrix leadership and act as the KOL for the Design Compliance organization. Ensure accurate results, adherence to Company protocols, timely completion of projects, and the creation of Design History Files.
  • 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.
  • 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 independently, quickly, and decisively.


At Employer, each one of our 65,000 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 Employer
Employer 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.

*IND-LSG




Employer 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.
Associated topics: attorney, company, compliance, compliance department, compliance office, corporate attorney, internal, legal, legal department, market

More Jobs Like This