GMP Operational Quality Senior Specialist

Job Description JOB TITLE: GMP Operational Quality Senior Specialist LOCATION: 50 Northern Ave, Boston, MA, 02210 OPENINGS: 1 DUTIES: Supports the principles and application of quality assurance and regulatory compliance. Supports or executes a wide range of standard activities and supports new/existing project initiatives. Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations and Out of Specification (OOS)/Out of Trend (OOT) investigations ensuring appropriate CAPA actions are implemented/identified. Supports change control assessments, implementation and closure. Identifies and facilitates continuous improvement efforts for quality procedures and systems. Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed. Represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills. Support continuous improvement projects. REQUIREMENTS: Employer will accept a Bachelors degree in scientific field such as Chemistry or Biology or related field and 5 years of experience in the job offered or in a GMP Operational Quality Senior Specialist -related occupation. Alternatively, employer will accept a Masters degree in scientific field such as Chemistry or Biology or related field and 2 years of experience in the job offered or in a GMP Operational Quality Senior Specialist -related occupation. Position requires demonstrable experience in the following: Working in Quality Assurance roles specifically within pharmaceutical industry. Driving regulatory compliance per various Health Authority requirements and internal quality systems. Driving quality events including deviations, root-cause analysis, CAPA processes and change control. Reviewing and approving of technical documentation for product stability protocol generation and initiation, stability testing data, data trending reports and Annual Product Review reports. Driving oversight of stability testing, stability program management and associated analytical investigations. Collaborating with contract manufacturing laboratories, internal test labs, and Quality groups for GMP audits. Driving SOP development and process improvements related to Chemistry, Manufacturing and Control (CMC) activities. Executing analytical technologies such as HPLC, dissolution, GC, KF or related chemistry skills. Rate of Pay: $106974.00 - $139200.00 CONTACT: Send Resume to Ken Strecker at Ken_Strecker@vrtx.com. Reference 12140.781. EOE. #LI-DNI Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com. Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortunes 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change peoples lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.