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

Open nowPosted today

Senior Quality Lead

roche305 open roles

Where
South San Francisco
Get the CV for this job

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

Your applicationOpen nowSenior Quality Leadroche · South San Francisco

  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 roche'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.

10.5% of postings close within 7 days. Measured by our own scanner across the market. roche postings stay open a median of 7 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.3%3 days
  3. 10.5%7 days
  4. 15.9%14 days
  5. 34.1%30 days
This job: posted today

roche median: 7 days open

The posting

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Genentech / Roche!

In Pharma Development Quality (PDQ), we strive for confidence in the integrity of our data and processes, agility, and unrivaled transparency with health authorities, patients, and society. Our work provides leadership, know-how, and partnering on quality across Molecules (GCP), Products (Drug and/or Medical Devices), Pharma affiliates, and global regulated processes.

This role supports the Roche/Genentech Organization by developing and delivering Quality Assurance strategies, audits, and conclusions for post approval products, affiliates and processes, based on a risk-based approach. Quality Assurance strategies are based on the Critical to Quality framework, encompassing Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Medical Device, and Computer Systems (CS) requirements.

The Opportunity

We are seeking an experienced Senior Quality Lead to join the Quality Assurance Programs team. You will bring diverse thinking and technical experience in various Quality disciplines (e.g., GCP, CSV, device).

Note: This role requires strong level GCP knowledge and will be accountable for the quality assurance aspects and leading/supporting inspections of key molecules. CSV and device are preferred but not the main requirement.

Key Responsibilities:

The Senior Quality Lead is a highly experienced Quality Professional who:

  • Designs and delivers Quality Strategies and conclusions for assigned Molecules by applying a risk-based approach based on the Critical to Quality (CtQ) framework. Establish strong partnerships with business stakeholders and independently define the Quality Assurance approach, assessing specific risk areas and proposing strategy modifications.
  • Define and Lead Audits: Define the audits required to deliver the Quality Assurance strategy and lead the development of methodology, including the use of data analytics.Independently perform and lead audits, managing preparation, conduct, presentation, timely reporting of outcomes, and evaluation of actions taken.
  • Issue Management: Independently manage complex quality issues, group individual findings into systematic issues for process improvement, and escalate significant issues to PDQ management.
  • Quality Conclusion and Stakeholder Communication: Independently draw conclusions on the Quality Positions and ensure appropriate action plans are developed to determine acceptability of evidence of compliance. Lead the presentation of observations and associated compliance risks to business stakeholders and Pharma representatives, including discussions with Legal and Regulatory Affairs.
  • PDQ Goals and Initiatives: Contribute and participate in PDQ goals and initiatives to the execution and delivery of PDQ work and the development of PDQ processes.
  • Health Authority Inspections:Lead and support regulatory authority inspections.
  • Mentor and support the development of Quality Leads within the team.
  • PDQ Leadership: Contribute to the long-term strategic direction of PDQ, lead departmental or cross-functional compliance projects, and lead the development/revision of PDQ processes and procedures (SOPs, Work Instructions).
  • Expertise and Mentorship: Maintain expert knowledge of GCP/GVP regulations, company policies, and SOPs, assess the impact of new regulations, and act as a trainer and mentor for International and Senior Quality Leads.
  • Networking: Maintain and influence partnerships with senior business stakeholders and PDQ domains. Facilitate cross-functional collaboration to ensure quality standards are met globally.

Who You Are

Professional and Technical Requirements:

Qualifications

  • Bachelor’s degree or equivalent in scientific or quality-related field. Advanced degree preferred.
  • Demonstrated applied knowledge of clinical / pharmacovigilance / drug safety and regulatory requirements.
  • Project management experience with proven leadership, mentoring and coaching; Demonstrated ability to effectively organize and execute tasks
  • High degree of experience, competency, and proven track record leading multiple complex audit types in multiple GCP areas.

Preferred

  • Device / CSV experience
  • Strong digital and data literacy
  • Experience hosting, managing and/or supporting regulatory authority inspections; Ability to formulate clear business questions that can be answered with data and utilize data/visualization tools to generate insights.
  • Proven ability to influence and negotiate effective solutions, drive change, and assimilate new compliance information/trends.
  • Proven record of working in a global, multicultural matrixed organization (multi-lingual skills desirable).

This role is based at our South San Francisco, CA campus. (Onsite presence is preferred, however, a remote option is a possibility.)

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $141,000 - $261,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

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 roche'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 roche'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

    roche'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.