Thermo Fisher Scientific-Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.
JOB SUMMARY/OBJECTIVE:
Responsible for a the managing a group of Quality SMEs who ensure the Quality in different multidisciplinary customer project teams, and as a liaison among customers and other departments.
Leads, as applicable, meetings focused on quality items, product-related projects, test method transfers and validations, and customer related topics.
REPORTING RELATIONSHIPS: Reports to Director of Quality with 2-3 direct reports
ESSENTIAL JOB FUNCTIONS:
- Manager of a team of quality specialists who are responsible to ensure the quality of Client projects for the actions follow-up and any quality deliverable for the project team.
- Provide specific technical knowledge for the Quality Unit organization (participating on investigations, studies and trending evaluation as well as innovation and improvements projects).
- Collaborate to ensure that tasks are prioritized, completed on time, and communicated in an effective and timely manner.
- Perform, review, approve (as applicable) and follow up tech transfers and methods validation documentations related to the different customer’s projects.
- Prepare and execute specific protocol studies requested by customers and present data and reports (internally and in front of customers).
- Perform the monitoring of the process from the quality perspective.
- Supports Lot Disposition for the batch release.
- Creation, review and approval (as applicable) of Stability Protocols and Reports.
- Manages QMS items requiring Client review.
- Create, review and approval of product specifications for each specific customer as applicable.
- Review and approve process sampling plans and process descriptions.
Ensure regulatory and customer inspection readiness and represent the department and participate in audits as required.
Perform other duties as assigned.
EDUCATION AND QUALIFICATIONS:
- BS in Biological Science or related technical field.
- At least 8-10 years of related experience in the Quality Unit.
- Extensive exposure to cGMP environment.
- Strong organizational and time management skills. Prioritization and problem-solving skills.
- Strong knowledge of Quality procedures, processes and guidelines. Recognized by colleagues as a source of expertise.
- Experience leading conversations with customers (internal and external).
- Strong interpersonal and communications skills; written and oral.
- Understanding of applicable regulatory requirements.
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionâenabling 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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