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Job ID :
Location :
US - Pennsylvania - Pittsburgh
Job Description
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, and you’ll be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you’ll find the resources and opportunities to make significant contributions to the world.

The Global Quality Lead, Production will report to the VPGM Safety & Production and dual report into the Sr. Director, Global Quality, and will have the regional Supplier Quality Production Specialists reporting to them. This role will be responsible for developing the global quality strategy and requirements to support the Production Solutions program and will ensure alignment with Global Quality department, Supply Chain, Supplier Compliance, and regional Production Solutions leads. The production quality strategy includes implementation and compliance to supplier quality agreements to establish expectations, the evolution of value-added services to offer to customers, and ensuring reliable and validated processes are in place to meet customer requirements. Additionally, this individual will interact with the customer as it relates to Global Quality Production requirements and issue resolution. This role will closely work with the Global Quality, Supplier Compliance, and Supply Chain counterparts among other departments as needed.

Key Responsibilities:
  • Develop and execute on Global Quality requirements for Production Solutions with support of Global Quality, Supply Chain, Transportation, IT, and other departments, as needed.
  • Define Quality Mission statement for Production Solutions and set expectations and boundaries to Production’s role and commitment to serving customers.
  • Be an interface with the customer (relationship management) as needed for Global Production Solutions as it relates production quality questions, problem solving, and issue resolution. Bring in Global Quality personnel to interact with customers when required.
  • Understand customer KPIs for delivery attributes with regards to required deliverables and required production parameters, and translate the customer KPIs for CCG Operations/Supply Chain.
  • Person is responsible for leading or participating in audits impacting customers served within the Production Environment.
  • Be a conduit with Customer Quality Leadership to ensure interpretation of quality requirements that need to be met to service Production Solutions customers.
  • Assist the customer to interpret the customer GMP (manufacturing) requirements into delivery requirements.
  • Finalize list of suppliers (including self-manufactured companies) and sites and other operations details to be included as part of supplier quality agreements and supplier guide.
  • Coordinate with strategic suppliers on supplier agreements and/or Terms and Conditions conformity.
  • Provide input into the supplier agreements with regards to the SLAs (service level agreements) that we need to support for change notifications, certificates, recalls, etc. and interact with suppliers to ensure delivery as per GxP quality agreements as needed. Sign-off on supplier quality agreements to support Production Solutions.
  • Review quality complaints as it relates to Production Operations customers for tracking, further investigation, and assistance with timely closure.
  • Communicate Production Operations supplier quality metrics to the Global Quality group from all self-manufactured companies and external strategic suppliers to enable one interface.
  • Provide input to Portfolio Management for portfolio expansion to support Production customer needs globally.
  • Facilitate development of infrastructure at global sites to support GxP customers for delivery readiness and in support of the vetted quality agreements.
  • Work with 3PL and other carriers to meet GxP customer requirements.
  • Be an independent reviewer for CCG Production Solutions.
Minimum Qualifications:
  • Bachelor of Science or Art’s Degree in related technical or scientific field.
  • 7+ years of experience in Quality compliance.
  • 3+ years of managing others in a matrix organizational structure.
  • Application of 21 CFR Part 820 Quality System Regulations (QSR), ISO 9001/ISO 13485 or similar experience including Canadian, European, and APAC equivalent.
  • Demonstrated experience with FDA and Notified Body inspections.
  • Willingness and ability to travel from 25-50%, including international.
Preferred Qualifications:
  • MBA or other advanced degree.
  • Medical Device or Pharmaceutical distribution / manufacturing experience.
  • Ability to work in a multinational/multicultural environment with strong global business acumen.
  • Excellent written and verbal communication skills to effectively present to all levels of an organization internally and externally and proactively work and cooperate with other departments, suppliers and customers.
  • Demonstrated success with being results and proactive solution driven, with strong ability to think critically to overcome potential business hurdles to complete tasks.
  • Courageous, outgoing, analytical, disciplined, agile, and team oriented.
This position has been approved for Relocation Assistance.

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.

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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