Senior Manager, Manufacturing Technical Operations
The Sr. Manager, Manufacturing Technical Operations (MTO) is responsible for quality event compliance MTO teams supporting Vertex Cell and Gene Therapy (VCGT) manufacturing operations for cell manufacturing in Boston, Cambridge, and Providence. The Sr. Manager, MTO is responsible for management and oversight of the deviation, corrective and preventive action (CAPA), analytical investigation and change control center of excellence teams. This includes all aspects of quality event ownership including metric reviews, cross-functional escalation meetings and establishing team best-practices for compliance to ensure on-time and thorough completion. The MTO Manager will be pivotal for maintaining quality event management across cell manufacturing. This role is an on-site position in our Boston location. This role will require some regional travel to support at our Cambridge and Providence manufacturing locations and ad-hoc weekend flexibility to support our cell manufacturing clinical timelines.
Manage 3-4 teams (varying in size from 3-10) for deviation, CAPA, analytical investigation, risk assessment, and change control.
Establish and run monthly quality event record escalation meetings with CMC Core Team and other cross-functional management.
Lead cross functional investigations for deviations to determine root cause and present findings and recommendations to CMC leadership team for alignment subsequent draft and manage appropriate CAPAs.
Establish and continually promote MTO best practices to further establish quality event record center of excellence teams.
Facilitate risk assessments with cross-functional team including process development, manufacturing, quality control, quality assurance, regulatory.
Maintain compliance to company policy and regulatory guidance.
Provide continuous support to all stakeholders to ensure successful product release.
Act as quality record subject matter expert in inspections and audits with regulatory agencies.
Demonstrate Vertex shared 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.
Bachelors degree in science or related discipline
10+ years progressive experience in pharmaceutical
development and manufacturing.
6+ years of experience mentoring and managing staff.
Understanding of science and technology of GMP cell and gene manufacturing environment.
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.
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.