Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowFirst seen 5 days ago

Snr Director, Quality CGT Personalized Medicine

Lifelancer3,750 open roles

Pay
$180,800 – $271,200 a year
Where
Remote
Work mode
Remote
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowSnr Director, Quality CGT Personalized MedicineLifelancer · Remote

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Lifelancer's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: first seen 5 days ago

The posting

Job Title: Snr Director, Quality CGT Personalized Medicine

Job Location: Boston, MA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Job Description

General/Position Summary

The Senior Director, CGT Quality Systems, Personalized Medicine provides strategic Quality leadership for personalized medicine and advanced cell therapies across the patient journey. The role is accountable for advancing Quality oversight, governance, compliance, and continuous improvement while ensuring efficient, patient-centric process across the end to end patient journey.

This highly cross-functional position requires strong matrix leadership and partnership with Global Quality and Manufacturing, MS&T, Regulatory, Commercial, and Supply Chain stakeholders. Success requires the ability to influence enterprise decisions, build strong partnerships, and drive alignment through executive presence and effective communication. The ability to balance long-term vision with flawless execution of complex business and quality priorities is key for the position.

Key Duties & Responsibilities

Leadership, Strategy & Organizational Capabilities

  • Provide strategic Quality Systems leadership in support of personalized medicine /advanced CGT programs, ensuring alignment with CGT Business Objectives, Vertex Global Quality Strategy, commercial priorities, regulatory expectations, and patient-centered outcomes.
  • Define, prioritize, and execute the CGT Quality Systems across clinical, launch, and commercial lifecycle stages.
  • Partner with stakeholders to ensure effective risk management, resolution and mitigation plans are identified, established, and executed.
  • Lead, mentor, and develop team members; build organizational capability and foster accountability, collaboration, innovation, and operational excellence.
  • Leverage technical and Quality expertise across CGT QA to resolve critical challenges, drive timely decision-making, and ensure effective communication and escalation of risks, constraints, and commitments.
  • Create and foster a culture of collaboration, quality excellence, continuous improvement, transparency, and accountability across Quality and partner functions.
  • Responsible for leading and participating in key CMC Quality initiatives to advance and mature Vertex’s Global Quality Systems.

Quality Systems & Compliance Oversight for Advanced CGT Personalized Medicine

  • Provide End to End compliance oversight for personalized medicine/advanced CGT internal and external quality operations, ensuring quality remains compliant with applicable enterprise Vertex Global Quality procedural requirements and global regulations.
  • Establish compliance governance routines to proactively monitor compliance trends, operational performance, and emerging risks that may impact product quality, patient safety, supply continuity, or program execution; lead or support risk-based mitigation plans, continuous improvement actions, and sustainable process enhancements.
  • Partner with digital stakeholders to ensure CGT user requirements are embedded in lifecycle management projects from design through implementation including sustainment.
  • Support inspection readiness and audit-related activities in relation to Quality CGT oversight.

Patient Treatment Journey Quality Oversight

  • Lead and provide Quality oversight across the end to end patient CGT treatment journey assuring GMP requests are assessed, governed, documented, escalated, and resolved in a timely, compliant, risk-based, and patient-centric manner.
  • Chair or support cross-functional review of GMP related patient treatment journey requests including requests involving patient-specific constraints.
  • Ensure Quality Management Review Boards are executed in line with Global Quality System requirements when quality or compliance impact is identified across the patient treatment journey.

Analytics, Data Integrity & Continuous Improvement

  • Partner with Global Quality and cross-functional stakeholders to support development and deployment of advanced digital reporting solutions and use of artificial intelligence in CGT to enable transparent governance, decision-making, and escalation of quality and operational risks.
  • Improve compliance and strengthen proactive quality management, efficiency, data integrity, and processes maturity and scalability across CGT investigations, change controls, risk assessments, CAPA, and management review.

Required Education Level

  • Bachelor's degree in engineering, life sciences, pharmaceutical sciences, or related technical discipline required.
  • Preferred: Master's degree in business analytics, management life sciences, or related field.

Required Experience

15+ years of experience and 7+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

  • Broad experience in quality and compliance oversight for allogeneic/autologous cell manufacturing processes, or other personalized medicine modalities from development through commercial lifecycle.
  • In-depth knowledge of global health authority expectations and GxP requirements across the lifecycle for cell and gene therapy, biologics, and advanced therapy products.
  • Enterprise Impact & Influence with the ability to shape decisions across the organization through strong partnerships, communication, and executive presence.
  • Balance long-term vision with operational excellence, driving quality transformation while ensuring compliance and patient-focused outcomes.
  • Ability to apply risk management principles, critical Thinking and Problem Solving skills

Other Requirements

  • 15% travel
  • Hybrid role in Boston, MA

Pay Range:

$180,800 - $271,200

Disclosure 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:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: 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-Hybrid

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 [email protected]

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Lifelancer's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Lifelancer's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Lifelancer's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.