When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
How will you make an impact?
In this role, you will lead from a Quality perspective a portfolio of clients in partnership with Business Managers. You will update quality plans/quality performance for clients, support product transfers from Pharmaceutical Development Services (PDS) and external to Commercial operations and approve deviations/OOS/OOT investigations, validation protocols/reports, change controls, technical transfers, among other items. You will lead Failure Mode and Effect Analysis (FMEAs) and process improvements determined from trending data.
What will you do?
- Quality approvals and timely Deviations/Out of Specifications/Out of Trends, validation protocol/reports, change controls, technical transfers
- Ensures resolution of significant quality issues with the client through coordination and collaboration of internal functional resources to identify, propose and carry out an efficient plan to settle the issue, while protecting product quality and patients safety
- Responsible for batch disposition in the case of deviations
- Facilitate content of Quality Huddles, represent quality at RAPIDs
- Accountable for DR impacts to POLCA boards, and material under investigation
- Lead Risk Analysis
- Lead a portfolio of Clients and will be the key Quality contact
- Prepare quality presentations for Client meetings and present
- Assure Continuous Quality improvement in plant related to trends from Quality systems
- Lead Quality initiative and provide quality assessments on process improvement activities such as Mini Transformations or Kaizens
- Work with management to resolve project issues and resource constraints within the team
- Support decision making on projects and future directions by trending deviations in TrackWise (TW)
- Support PAI or Client Audits as necessary
- Prepare, update, and negotiate terms of Quality agreements with the client
How will you get there?
- Minimum 5 years experience in a senior Quality Assurance or Compliance position in the pharmaceutical industry
- B.Sc. in Chemistry or Biology
- Experience writing deviations and investigations
- ASQ certification is an asset
- Experience working with clients is an asset
- Ability to adapt to a changing environment quickly and easily
- Ability to develop solutions that are mutually beneficial to the client and to the company
- Ability to function independently and as part of a team
- Strong communication and presentation skills, verbal and written
To Apply, please click the following link: https://thermofisher.contacthr.com/73546883
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