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

Open nowPosted 15 days ago

Director, Quality Compliance

Minaris4 open roles

Where
Allendale, 75 Commerce Drive, Allendale, New Jersey, United States of America
Get the CV for this job

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

Your applicationOpen nowDirector, Quality ComplianceMinaris · Allendale, 75 Commerce Drive, Allendale, New Jersey, United States of America

  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 Minaris'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.

7.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.7%1 day
  2. 3.5%3 days
  3. 7.8%7 days
  4. 14.6%14 days
  5. 34.1%30 days
This job: posted 15 days ago

The posting

The Director of Compliance is responsible for ensuring that the organization maintains a robust, inspection-ready state across all GMP operations. This role provides strategic oversight of quality systems, regulatory compliance, and inspection readiness for cell and gene therapy manufacturing and testing operations. The Director will serve as a key partner to senior leadership, ensuring regulatory requirements (FDA, EMA, TGA, and other health authorities) are consistently met and that quality is embedded as a driver of operational excellence.   Essential Functions and Responsibilities  

Lead the development, implementation, and continuous improvement of the Compliance & Inspection Readiness Program, ensuring proactive identification and mitigation of compliance risks.  Direct and oversee regulatory inspection management, and follow-up responses, ensuring timely closure of findings and sustainable remediation. Provide oversight of investigations, root cause analysis, CAPA planning, and effectiveness verification, ensuring systemic issues are resolved and recurrence prevented. Govern change control management, facilitating cross-functional risk assessments and approvals to maintain product quality and regulatory compliance. Monitor, assess, and communicate compliance metrics and trends to senior leadership, ensuring visibility of key risks and progress. Partner with manufacturing, validation, and development teams to ensure compliance is embedded in all operations. Manage, mentor, and develop compliance and quality staff, fostering a culture of accountability, technical excellence, and continuous learning. Serve as a primary liaison with regulatory agencies during inspections, and information requests. Regular and reliable attendance on a full-time basis. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.  Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture. Regular and reliable attendance on a full-time basis. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture. Regular and reliable attendance on a full-time basis. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture. Other duties as assigned.

  Knowledge, Skill & Ability   Experience with the following:

Direct Health Authority communication and providing follow-up responses.  Inspection related training, inspection readiness and management.  Supporting audits.  With risk management, investigation, CAPA, and change control review and approval. presenting critical findings to leadership. 

  Education & Experience  

Bachelor's degree and or master's degree in pharmaceutical science, biology, chemistry, or related science.  Minimum 14 years of progressive GMP biotech experience, including leadership roles in both Manufacturing and Quality. Proven success in regulatory inspections (FDA, EMA, TGA, others) and product approvals for innovative biologics or cell & gene therapies. Strong knowledge of global GxP regulations, ICH guidelines, and advanced therapy regulatory requirements. Expertise in QMS systems (e.g., TrackWise/NextGen, Veeva, SAP, LIMS, MES, Oracle, BMRAM). Demonstrated experience in investigations, CAPA, change control, and inspection readiness programs. Strong leadership, influencing, and team-building skills with the ability to manage cross-functional stakeholders. Exceptional written and verbal communication skills; ability to represent the company effectively to regulators and clients.

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 Minaris'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 Minaris'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

    Minaris'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.