Quality Control Manager - External Relationships

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: May 29, 2023

Job Description:

Quality Control Manager - External Relationships page is loaded Quality Control Manager - External Relationships Apply locations Boston, MA time type Full time posted on Posted 4 Days Ago job requisition id REQ-18094 Job DescriptionGeneral Summary:The Manager, Quality Control provides oversight of external testing for Type 1 Diabetes (T1D) Cell Quality Control (QC). This includes management of testing performed by external testing labs for T1D Cell QC, analytical method transfer to external contract development and manufacturing organizations (CDMO), as well as non-GMP testing performed by T1D Cell QC for non-GMP Vertex groups.Key Duties and Responsibilities:

• Manage relationships with external testing labs performing tests for T1D Cell QC. This includes negotiation, review and approval of statements of work, generation of purchase orders, investigation of deviations and OOS, coordination of logistics for sample delivery review and archival of results.
• Manage analytical method technical transfer to external CDMO. This includes representing T1D QC in tech transfer meetings, review and approval of technical transfer and qualification protocols and reports, delivery of appropriate documentation to support transfer, such as SOP and qualification reports, potential onsite training of CDMO partners either at Vertex or at CDMO location
• Manage relationships with internal Vertex non-GMP requiring non-GMP testing from T1D Cell QC. This includes working with T1D managers and external groups to set the work requested, coordination of communication for sample delivery, reporting results, communication and resolution of unexpected results.
• Serves as T1D Cell QC representative in cross-functional, cross-departmental working teams.
• May participate in review of regulatory filings.
• Travel up to 10% may be required.Knowledge and Skills:
  • Strong knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections
  • Strong knowledge of analytical methodologies such as flow cytometry, cell based assays, qPCR, ELISA, BACT, endotoxin and applying/interpretation of GMP requirements
  • Effective communication skills, both verbal and written
  • Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
  • Experience with analytical method tech transfers and management of external testing at CRO.
  • Project or team leadership experience.Education and Experience:
    • Typically requires a Bachelor's Degree with 8 years of experience or a Master's Degree with 6 years of experience in the pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experienceCompany 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. Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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. Similar Jobs (5) Quality Control, Manager locations Boston, MA time type Full time posted on Posted 17 Days Ago Senior Quality Manager Product Complaints locations Boston, MA time type Full time posted on Posted 19 Days Ago About Us 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 multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) - a rare, life-threatening genetic disease - and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy.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 and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 13 consecutive years on Science magazine's Top Employers list and one of Fortune's Best Workplaces in Biotechnology and Pharmaceuticals and Best Workplaces for Women. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com -or follow us on Facebook , - Twitter , - 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 people's 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. ALERT: If you have signed up for Job Alerts, please be aware that Job Alert Matches are currently not working. During this time, please check our careers site regularly for all open opportunities. We apologize for this systems issue and hope for it to be resolved soon.

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