Thermo Fisher Scientific Hiring For Senior Quality Specialist at Somerville, MA Full Time

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply. We offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge, Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. Location/Division Specific Information Thermo Fisher Scientific – Viral Vector Services (VVS) is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future. This candidate will work primarily on site VVS Somerville MA site and may be expected to routinely travel to the Cambridge location. How will you make an impact? This Specialist of Supplier Quality is responsible for supporting core SQM processes including onboarding of new materials and suppliers, vendor/supplier change notifications (VCN/SCN), supplier corrective actions (SCAR), establishment of quality technical agreements (QTA) and supporting other supplier qualification activities, including supplier assessments, audits and performance evaluation. This candidate will help ensure compliance to the applicable directives, procedures, and regulations governing Supplier Management, as well providing quality support across all Brammer Bio sites (Cambridge, MA, Lexington, MA, and Alachua, FL). This candidate will work closely with internal partner including but not limited to Supply Management, Quality Control, Compliance, Legal and Quality Systems. What will you do? Lead Quality activities for key processes including Vendor/Supplier Change Notifications (VCN/SCNs) and Supplier Corrective Action Requests (SCARs) Initiate and finalize Quality Technical Agreements with highest risk suppliers. Provide Supplier Quality management support for the onboarding of new materials and suppliers. Coordinate the evaluation of supplier classification based on risk and oversee changes to the Approved Supplier (Vendor) List. Provide QA support and guidance for material specifications, change controls, investigations and CAPAs. Responsible for generating performance metrics, trends. Support SQM team during internal and external audits as well as regulatory inspections, as required. Oversee execution of the supplier/vendor audit schedule. Most supplier audits will be executed by Global Supplier Quality; however, auditing may be required. Manage the Approved Supplier (Vendor) List Travel: = 10% How will you get here? EDUCATION – A minimum of a Bachelor’s Degree is required in Chemistry, Life Sciences or Engineering. Equivalent combination of education, training and relevant work experience may be considered EXPERIENCE – Minimum of 5-8 years of experience in a GMP regulated industry, preferably biotech, pharmaceutical, or medical device 3-5 years minimum experience in Quality Assurance, preferably Supplier Quality. Experience in leading or managing teams. Experience in working with internal and external partners to assure compliance, remediation of issues by CAPA and continuous improvement of quality systems and business processes. Experience with key elements of the Quality system including change control, deviations and CAPA. Experience in writing, reviewing and approving GMP documents such as SOPs, Directives, etc. Knowledge, Skills, Abilities Strong understanding of global regulations pertaining to supplier management (particularly US, EU and Japan). Ability to work effectively across sites and partner with key internal stakeholder and external suppliers. Effective interpersonal and presentation skills. Effective oral and written communication skills Strong analytical and organizational skills. Ability to multi-task and meet deadlines in a fast-paced environment. Strong time management skills and the ability work well in teams, as well as independently. Physical Requirements: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment and read materials for prolonged periods of time; ability to site, reach with hands and arms, talk and hear others for a prolonged period of time. At Thermo Fisher Scientific, each one of our 80,000 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. Apply today []() 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.