Senior Manager, Manufacturing Technical Operations

Job Description

General Summary:

The Sr. 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. The Sr. Manager, MTO is responsible for management and oversight of the center of excellence teams for Change Controls, Risk Assessments, and QC events. 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. The MTO Sr. Manager will be pivotal for change management across CGT. 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 clinical cell manufacturing 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 may include both people managers and individual contributors.

• Manage QC deviation and analytical investigation center of excellence team, which is responsible for owning quality event records in QMS.

• Manage the CGT Change Control center of excellence team.

• Provide guidance to promote best practices at Change Control Review Board meetings.

• Manage risk assessment facilitation center of excellence team that leads cross-functional risk assessments for CGT programs.

• Establish and continually promote MTO best practices to further establish center of excellence teams.

• Act as quality record and QC event 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+ experience in people management.

• BS in microbiology, engineering or related discipline

• 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.

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.