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

Open nowPosted 15 hours ago

Director, External & CMC Quality Assurance

Scholar Rock35 open roles

Pay
$200,000 – $260,000 a year
Where
Cambridge, MA
Work mode
Hybrid
Get the CV for this job

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

Your applicationOpen nowDirector, External & CMC Quality AssuranceScholar Rock · Cambridge, MA

  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 Scholar Rock'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.

8.2% of postings close within 7 days. Measured by our own scanner across the market. Scholar Rock postings stay open a median of 4 days.

Share of postings closed within
  1. 1.8%1 day
  2. 3.8%3 days
  3. 8.2%7 days
  4. 15.2%14 days
  5. 34.2%30 days
This job: posted 15 hours ago

Scholar Rock median: 4 days open

The posting

Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.

As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.

Summary of Position:

Scholar Rock is seeking an experienced and motivated Director of Quality Assurance to support External and CMC Quality Assurance. This role will provide oversight of external partner (Contract Organization) governance for the manufacturing, testing, and release of biological products. This position will work cross-functionally with the CMC teams (Manufacturing, QC, MSAT, etc) and the external partners. This role is responsible for managing quality system records (change control, deviations, product complaints, batch disposition, etc.) and quality risk management to deliver product for clinical and/or commercial purposes. This role will also be responsible for advancing a strong quality culture for proactive issue identification and a state of inspection readiness. This position reports to the Sr. Director, External & CMC Quality Assurance.

Position Responsibilities

  • Provide Quality Assurance oversight over Drug Substance manufacturing of GxP biological product. This involves oversight of multiple CMOs as part of a complex supply chain that includes contract laboratories and other critical service providers.
  • Provide QA oversight of deviations, investigations, CAPAs, change controls, testing, product impact assessments, and disposition-related decisions.
  • Design and maintain a robust, scalable product disposition program for clinical trial material as well as commercial products across multiple markets.
  • Ensure continuous inspection readiness across outsourced operations and support health authority inspections, partner inspections, and due diligence activities.
  • Monitor partner quality performance through defined metrics, scorecards, and governance forums; identify trends and proactively escalate compliance or execution risks.
  • Partner cross-functionally to assess quality risk associated with process changes, deviations, investigations, comparability activities, tech transfer, and supply continuity issues.
  • Provide strategic guidance on quality requirements for product lifecycle activities, including clinical supply, commercial readiness, distribution, complaints, and post-approval changes.
  • Drive a culture of quality, accountability, and proactive issue identification across internal stakeholders and external partners.

Candidate Qualifications

  • BS/MS degree in a scientific discipline.
  • 12+ years of experience in the pharmaceutical/biotech industry (including meaningful experience in outsourced/virtual operating models), with 5+ years in leadership roles within Quality or related functions
  • Strong working knowledge of GMP/GxP requirements, FDA/EMA expectations, ICH guidance, and risk-based quality management principles.
  • Demonstrated success overseeing external manufacturers, testing laboratories, suppliers, and quality service providers.
  • Experience supporting biologics products across both clinical and/or commercial stages; demonstrated success driving continuous improvement.
  • Strong communication skills, sound scientific judgement, and the ability to balance strategic thinking with hands-on execution.
  • Highly proactive, decisive, and capable of independently managing key initiatives in a fast-paced commercial readiness and launch environment.
  • Engaged leader committed to building a strong quality culture through collaboration and mentorship.

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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 Scholar Rock'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 Scholar Rock'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

    Scholar Rock'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.