Position Title: Team Leader, Document Control and Archiving

Location: Somerville, MA

Thermo Fisher Scientific’s 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!

How will you make an impact?

The Team Leader, Document Control and Archiving supports day-to-day operations via oversight of all elements Document Control for the Cambridge and Somerville sites. These activities include, but not limited to, managing a team of quality specialists responsible for daily support activities related to knowledge management, issuance, document control, and archiving. The successful candidate will be the site subject matter expert for the electronic document management system (eDMS) and its associated repositories.

What will you do?

• Lead a team of 2-4 document specialists.
• Support current Good Manufacturing Practices (cGMP) operations through administration of the Quality Management System.
• Compile metrics as applicable for quality and operational reports.
• Support the continuous improvement and development of Quality Systems to ensure quality and adherence with cGMP.
• Manage electronic quality systems, including administration activities and maintenance of authorized user list.
• Supports internal and client audits and regulatory inspections.
• Manages a team of quality professionals responsible for document control and records management, providing oversight of daily activities and identifying development opportunities.
• Maintains the document control system and assures compliance with applicable procedures.
• Schedules and assigns the review and completion of workflows for controlled documents while also processing documents within the document management system.
• Collaborate closely within the Quality organization as well as with representatives from Global Procurement, Supply Chain, Manufacturing, Manufacturing Sciences and Technology, Quality Compliance, and Global Regulatory Sciences on cross-functional teams to resolve complex problems while meeting quality, productivity, and compliance objectives.
• Support the design, preparation and review of CMC documentation as appropriate.
• Collaborates with internal and external partners to achieve shared goals and ensure application of best practices
• Develops self and others to improve performance in current role and to prepare for future roles.
• Seeks and welcomes feedback and responds to coaching.
• Provides frequent feedback and coaching to others on ways to improve performance.
• Recognizes and celebrates successes.

How will you get here?

Education

• Minimum of HS Diploma/ GED required
• Bachelor’s degree preferred

Experience/Skills

• Minimum of 2 years of experience in pharmaceuticals manufacturing.
• 2 years of supervisory experience preferred.
• Demonstrated ability to empower exempt and non-exempt employees and demonstrated management skills.
• Thorough knowledge of cGMPs.
• Strong interpersonal and communications skills (written and oral).
• Strong digital literacy including Microsoft Word, Excel, and Access.

At Thermo Fisher Scientific, each one of our 100,000+ 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.