Sr. QA Specialist - Pharmaceutical Manufacturing

The Position This position is responsible for working together with the management team to set future quality direction and supporting the implementation of our ambitious goals by bringing the best practices from other Novo Nordisk sites. The person in this role will be responsible for performing reviews/approving of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all site bioloigics produced. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support records. Responsibility for developing and coaching QA colleagues as well as supporting manufacturing by being present on the manufacturing floor. This role will help drive implementation of quality improvement projects, and support cross functional projects across the site. This role is based onsite at our West Lebanon, NH bio-production facility Monday-Friday. Our facility is a 24/7 commercial scale GMP manufacturing facility. Relationships Reports to: Sr. Director, QA Essential Functions Responsible for training, mentoring and developing other QA colleagues. Responsible for identifying and assessing training needs and delivering training materials and programs, to include training of team members on compliance related issues and other QA related topics. Serve as Good Manufacturing Practice (GMP) expert that is responsible for evaluating and improving the effectiveness of training programs. Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues. Inform stakeholders regarding project goals and deliverables. Consult and mentor across business operations and provide specialized knowledge. Reviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting/trending. Reviews and approves Validation Documentation. Reviews and assesses Corrective and Preventive Action Reports. Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes. Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others. Other duties as assigned. Qualifications Education and Certifications: Bachelor’s Degree within a scientific or life science required. Master’s Degree preferred. Work Experience: Bachelor’s Degree with ten (10) years experience required. Master’s Degree with eight (8) years experience preferred. Six (6) years of direct QA experience preferred. Knowledge, Skills, and Abilities: Excellent written and verbal communication and negotiating skills in English are required. Strong planning and organization skills, with flexibility for changes in work priorities. Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken. Normally receives no instructions on routine work, and general instructions on new assignments. Determines and develops approach to solutions. Ability to work on complex Quality projects where analysis of data requires evaluation of identifiable factors. Ability to train and/or mentor Junior team members in QA Best Practices. Extensive knowledge in GMP API manufacturing in the pharmaceutical industry. Have proven experience with GMP manufacturing in the pharmaceutical industry. Have good stakeholder management skills and collaboration skills at all levels of the organization. Physical Requirements Local and International Travel: 0-5%. While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. This position may lift up to 10 pounds occasionally or constantly to lift, carry, push, pull or otherwise move objects. Visual a to perform close activities such as: reading, writing, and analyzing. Equal Opportunity Employer Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. #J-18808-Ljbffr Initial Therapeutics, Inc.