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Senior Manager, Manufacturing Technical Operations

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: July 10, 2024

Job Description:

Senior Manager, Manufacturing Technical Operations page is loaded Senior Manager, Manufacturing Technical Operations Apply locations Boston, MA time type Full time posted on Posted 3 Days Ago job requisition id REQ-22087 Job DescriptionThe Senior Manager, Manufacturing Technical Operations (MTO) is responsible for managing compliance related Quality records including, but not limited to, Deviations, CAPA's, Change Controls, Risk Assessments and Analytical and Quality Control Investigations supporting Biopharma Cell and Gene Therapy (CGT) in Boston, Cambridge, and Providence. This leader is responsible for management and oversight of the center of excellence teams for quality events and metrics, GMP cleaning, and training and documentation. This includes all aspects of record ownership, triages, investigation, CAPA and change controls. The person in this role will lead cross-functional escalation meetings and establish team best-practices for compliance to ensure on-time and thorough completion. This includes all aspects of MTOs operational compliance support with emphasis on tracking and executing CGT initiatives, implementing MTO best practices and ensuring exceptional internal and external department collaboration and communication. The Senior Manager will be pivotal for distributing and acting on metrics as well as maintaining MTO intake for support services. This role is an on-site position based in our Boston location. This role will require some regional travel to our Cambridge and Providence manufacturing locations and ad-hoc flexibility to support our cell manufacturing clinical hours of operation and timelines.Key Duties and Responsibilities:

  • Manage a team of direct reports which includes a combination of FTE and contractors. Direct reports include both people managers and individual contributors.
  • Monitor quality event metrics across CGT, escalate issues, propose improvements, and deploy MTO resources to support event closure.
  • Lead biweekly cross-functional quality event review committee for deviations, CAPA, change controls, analytical investigations with site leadership.
  • Establish project and quality event intake meetings and develop key project trackers to communicate timelines and expectations across stakeholders and leadership teams.
  • Responsible for project management tool oversight for all records owned by MTO team. Escalate issues and offer solutions to support compliance.
  • Develop team members to act as MTO flex team to support quality compliance teams for deviations, CAPAs and change controls to support business needs and compliance to release timelines.
  • Manage the CGT Training and Documentation center of excellence team.
  • Oversee outsourced service for GMP cleanroom and GMP warehouse cleaning.
  • Provide continuous support to all VCGT stakeholders for MTO services.
  • Establish and continuously promote MTO best practices to further establish operational and quality event record center of excellence teams.
  • Act as quality record and deviation process subject matter expert in inspections and audits with regulatory agencies.
  • Demonstrate the Vertex behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
  • Other duties and projects as assigned to meet departmental requirements.Qualifications:
    • Typically 10+ years progressive experience in pharmaceutical development and manufacturing.
    • Typically 6+ years of experience in people management.
    • BS in engineering or related discipline.
    • Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
    • Excel in interpersonal relations, showcasing ability to lead through influence and effectively lead high performing teams.
    • Expert level proficiency with technical writing and data visualization.
    • Excellent verbal and written communication skills.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. Similar Jobs (3) Senior Manager, Manufacturing Technical Operations locations Boston, MA time type Full time posted on Posted 3 Days Ago Sr. Specialist, Manufacturing Operations locations Boston, MA time type Full time posted on Posted 30+ Days Ago Senior Director, Packaging and Labeling Quality Operations (Hybrid) locations Boston, MA time type Full time posted on Posted 30+ Days Ago 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 Fortune's 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 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.
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Keywords: Vertex Pharmaceuticals, East Providence , Senior Manager, Manufacturing Technical Operations, IT / Software / Systems , Boston, Rhode Island

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