Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Office



Job Description



As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.



Summary:



This role is responsible for leading a portfolio of Clients through support of quality performance, oversight of product transfers to Commercial operations and to approve deviation/OOS/OOT investigations, validation protocols/reports, and change controls. The Quality Project Leader (QPL) must have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills, and excellent attention to detail. The QPL focuses on client facing activities including client experience and relationship management, Quality agreement negotiation and participating in client audits. In addition, this position provides QA support for the site Quality programs including rapid response to manufacturing incidents and investigation management.



Essential Functions:



Leads a portfolio of Clients and will be the key contact for Quality related topics.


Prepares and leads quality presentations for Client meetings.


Quality oversight not limited to Deviations and Laboratory Investigations, as well as support for validation protocol/reports, change controls, technical transfers.


Leads Quality initiatives and provides quality assessments on process improvement activities such as Kaizen events.


Ensures resolution of significant quality issues with the client through coordination and teamwork of internal functional resources to identify, propose and carry out an efficient plan to settle the issue, while protecting product quality and patients' safety


Supports decision making on projects and future directions.


Leads team member interactions with clients.


Supports PAI or Client Audits as necessary.


Assists with negotiation terms of Quality agreements with the client as required.


Works with and advises staff on administrative policies and procedures.


Provide QA support for technical transfer Team and new equipment implementation.



Education:

• Bachelor's Degree in Chemistry, Biology, Engineering or relevant science is preferred.

• 5+ years in a Quality Assurance or Compliance position or a combination of experience encompassing a minimum of 2+ years of CDMO experience paired with 1+ years of customer facing interactions or in the pharmaceutical industry is preferred.

• Outstanding leadership skills: a demonstrated ability to motivate and empower.


• Ability to develop solutions that are mutually beneficial to the client and to Thermo Fisher.


• Ability to function independently and as part of a team.


• Superior communication and presentation skills, verbal and written, fluent in the English language.