Senior Manager, Manufacturing Technical Services

Vertex Pharmaceuticals

Boston (MA)

On-site

USD 142,000 - 213,000

Full time

3 days ago
Be an early applicant
Application generator

An application made for this job — a tailored resume and cover letter that speak straight to the posting.

Get past ATS filters

Benefits offered by this job

Annual bonus
Equity awards
Overtime pay (as applicable)
Medical, dental, vision benefits
Paid time off

Job summary

Vertex Pharmaceuticals in Boston, MA, is seeking a Senior Manager for Manufacturing Technical Operations to lead quality-record execution across CAPAs, deviations, and change controls in a CGT manufacturing setting.

The role requires 2nd shift/weekend availability to support manufacturing needs and a strong background in cGMPs, quality systems, and complex investigations. Collaboration with QA, Manufacturing, and other functions is essential to drive improvements and ensure inspection readiness.

Qualifications

  • Bachelor's degree in engineering, Life Sciences, or related technical discipline; equivalent combinations may be considered.
  • 6+ years of experience in biopharmaceutical manufacturing, quality, manufacturing sciences, process engineering, or process development.
  • Experience mentoring, supervising, or managing staff is preferred.

Responsibilities

  • Lead a high-performing team responsible for quality-record execution (CAPAs, deviations, change controls).
  • Provide strategic oversight for complex CAPA and change-control records.
  • Lead cross-functional investigations to determine root cause and recommend corrective actions.

Skills

Leadership experience
Quality systems
GMP knowledge
Cross-functional collaboration
Root cause analysis
Project management
Data-driven decisions
Communication skills
Biopharma manufacturing
Cell & Gene Therapy familiarity

Education

Bachelor's degree in engineering or life sciences

Job description

Job DescriptionGeneral Summary:The Senior Manager, Manufacturing Technical Operations (MTO), is responsible for developing and executing the quality-record strategy for quality events supporting internal Cell and Gene Therapy (CGT) manufacturing. The role provides end-to-end oversight of quality events, including corrective and preventive actions (CAPAs), change controls, deviations, and analytical investigations.Responsibilities include reviewing quality metrics and trends; escalating cross-functional risks and issues; and establishing operational excellence practices that strengthen quality event compliance, investigation quality, timely record closure, and the sustainable implementation of CAPAs and change controls. The Senior Manager partners closely with Manufacturing, Quality Assurance, and other cross-functional stakeholders to promote a quality event center of excellence and support continuous improvement across the site. This is an on-site position at the Boston site that requires 2nd shift/weekend availability to support manufacturing business needs.Key Duties and Responsibilities:Lead and develop a high-performing team of five or more responsible for quality-record execution, including change controls, CAPAs, deviations, and analytical investigationsProvide strategic oversight and project leadership for complex, high-impact CAPA and change-control recordsLead cross-functional investigations for major and critical deviations to determine root cause, define appropriate corrective and preventive actions, and present findings and recommendations to the leadership team for endorsementEstablish, implement, and continuously promote MTO- and QA-aligned best practices to advance quality-event center-of-excellence capabilitiesLead triage and proposal meetings for deviations, analytical investigations, CAPAs, and change controlsMonitor quality-event performance, including compliance metrics, record-aging data, and recurring trends, to identify risks, prioritize work, and allocate resources using data-driven decisionsDrive continuous improvement of departmental and site practices, procedures, systems, and activities related to quality-event management.Partner with cross-functional stakeholders to ensure timely, compliant, and effective closure of quality recordsSupport inspection readiness by ensuring quality-event documentation is complete, scientifically sound, and aligned with applicable GMP requirementsPerform other duties and lead additional projects as needed to meet departmental and business requirementsKnowledge and Skills:In-depth knowledge of the conceptual and practical application of current Good Manufacturing Practices (cGMPs) within a pharmaceutical or biopharmaceutical manufacturing environmentStrong understanding of global GMP requirements and quality-system expectations supporting GMP manufacturingDemonstrated experience managing complex projects, priorities, timelines, and cross-functional stakeholdersStrong analytical and problem-solving skills, including the ability to evaluate trends, identify systemic issues, and implement sustainable improvementsExcellent verbal and written communication skills, with the ability to tailor messaging, terminology, and level of detail to the intended audienceStrong leadership skills and a demonstrated ability to collaborate, influence, and build productive relationships across functionsExcellent planning, prioritization, and organizational skills, with the ability to balance production, development, compliance, and continuous-improvement needsEducation and Experience:Bachelor’s degree in engineering, Life Sciences, or a related technical discipline; equivalent combinations of education and relevant experience may be considered6+ years of experience in biopharmaceutical manufacturing, quality, manufacturing sciences, process engineering, or process development2+ years of experience mentoring, supervising, or managing staffExperience supporting GMP manufacturing environments and leading complex investigations, CAPAs, deviations, and/or change controls is preferredExperience in cell and gene therapy manufacturing is preferredAt Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.Pay Range:$142,000 - $213,000Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.Flex Designation:On-Site DesignatedFlex Eligibility Status:In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.#LI-OnsiteCompany InformationVertex 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
Get your free, confidential resume review.
or drag and drop your file here.
Similar jobs

Similar jobs worth comparing

Senior Manager, Manufacturing Technical Services
Senior Manager, Manufacturing Technical Services

Biopharma Careers • Boston (MA)

On-site
USD 142,000 - 213,000
Associate Director, Shift Quality Operations (Cell and Genetic Therapies)
Associate Director, Shift Quality Operations (Cell and Genetic Therapies)

Biopharma Careers • Boston (MA)

On-site
USD 154,000 - 231,000
Associate Director, Shift Quality Operations
Associate Director, Shift Quality Operations

Vertex Pharmaceuticals • Boston (MA)

On-site
USD 153,000 - 231,000
Associate Director, GMP Operational Quality (Biologics) Wed-Sat
Associate Director, GMP Operational Quality (Biologics) Wed-Sat

Biopharma Careers • Boston (MA)

On-site
USD 157,000 - 235,000
Executive Director Quality, Cell & Gene Therapy
Executive Director Quality, Cell & Gene Therapy

Biopharma Careers • Boston (MA)

On-site
USD 245,000 - 367,000
Health benefits
Paid time off
401(k) matching
Executive Director Quality, Cell & Gene Therapy
Executive Director Quality, Cell & Gene Therapy

Vertex Pharmaceuticals • Boston (MA)

On-site
USD 244,000 - 368,000
Senior Director, Head of Technical Services, T1D CT Mfg Ops
Senior Director, Head of Technical Services, T1D CT Mfg Ops

Biopharma Careers • Boston (MA)

Hybrid
USD 217,000 - 325,000
Director, Cell & Gene Therapy Research Technology (Boston)
Director, Cell & Gene Therapy Research Technology (Boston)

Vertex Pharmaceuticals • Boston (MA)

Hybrid
USD 198,000 - 297,000
Senior Director Cell & Genetic Therapies Quality - Personalized Medicine
Senior Director Cell & Genetic Therapies Quality - Personalized Medicine

Vertex Pharmaceuticals • Boston (MA)

Hybrid
USD 181,000 - 271,000
Associate Director, GMP Operational Quality
Associate Director, GMP Operational Quality

Biopharma Careers • Boston (MA)

Hybrid
USD 157,000 - 235,000
Hybrid work model
401(k) and matching contributions