Senior Corporate Counsel, Global TechOps & Pharma Quality

Genentech; San Francisco (CA); On-site; USD 204,000 - 378,000; Full time

Job summary

Genentech in South San Francisco is seeking a Senior Corporate Counsel (Global TechOps & Pharma Quality) to provide global regulatory and transactional counsel for the Pharma Manufacturing unit.

You will partner with PT Quality and Regulatory leaders, advise on FDA/cGMP inspections, draft quality agreements, supervise outside counsel, and help ensure manufacturing compliance across sites worldwide.

Qualifications

• 7+ years of experience with US FDA/cGMP in pharma/biotech corporate or law firm.
• J.D. and active bar admission or eligible for CA In-House Counsel.
• Experience with manufacturing quality/regulatory matters is preferred.

Responsibilities

• Advise on FDA/cGMP regulatory and manufacturing compliance matters.
• Provide legal risk guidance to PT Global Head of Quality and Regulatory.
• Support US FDA facility inspections and foreign health authority inspections.
• Draft and negotiate quality-related agreements with external manufacturers.
• Manage outside counsel for relevant legal matters.
• Collaborate with cross-functional teams to ensure quality and regulatory alignment.

Skills

Regulatory counseling

Legal risk guidance

Communication skills

Team collaboration

Willingness to travel

Education

J.D. degree

Bar admission or CA eligibility

Job description

The Position

We are seeking to hire a Senior Corporate Counsel (Global TechOps & Pharma Quality) in Global Legal Technical Operations & Facilities. In this role you will focus on global support of our global Pharma Manufacturing unit and its sites, including regulatory and transactional counseling on FDA/cGMP, manufacturing supply and development agreements, and other related matters.

Great medicine can't change the world if it never leaves the lab. Our Pharma Technical Operations (PT) organization is the global backbone that transforms scientific discoveries into real-world therapies. Joining our Global Legal Technical Operations & Facilities team means stepping onto a highly collaborative, global team of experts. Together, we provide the proactive legal support that empowers PT to manufacture and deliver medicines safely and efficiently. You’ll be trusted to advise on complex, high-stakes matters, knowing that your daily work supports our patients and our company’s global ambition to prevent, stop and cure diseases.

The Opportunity

Key responsibilities of this role may include, but not be limited to, the following:

• Advising on global regulatory and compliance matters relating to FDA, EMA, or other global requirements for manufacturing compliance, regulatory enforcement actions, risk management, and commercial operations involving manufacturing practices—including Current Good Manufacturing Practices (cGMP), quality system requirements, and other quality-related issues and agreements.

• Partnering as lead counsel directly with the PT Global Head of Quality and PT Global Head of Regulatory to provide legal risk guidance on critical quality and regulatory matters, including quality governance structures, change control oversight, and significant compliance trends to prevent enforcement actions and protect product integrity worldwide.

• Providing strategic legal advice on US FDA facility inspections and foreign health authority inspection as well as internal GMP audits.

• Partnering with PT Quality organization to address critical quality issues, supply interruptions, manufacturing deviations, health authority notifications, and field actions.

• Advising the External Quality organization responsible for CMO and CDMO oversight to structure novel quality agreements and align on compliance standards for external manufacturing partners and supplier networks.

• Managing outside counsel retained to support legal matters.

The How

Legal excellence accelerates in combination with the right business- and solutions-focused attitude, mindset, and ways of working. Here is who we are looking for:

Communication and Leadership

• Pro-active and confident individual who is committed to driving change.

• Strong verbal and written communication skills.

• Ability to communicate complex and highly technical information clearly and concisely.

• Commitment to working as a team player in a multinational legal department.

• Excellent interpersonal skills with high cross-cultural sensitivity.

• Willingness to travel.

Our Expectations

• Strong business acumen; sensitive to business needs; views change as an opportunity; eager to work in a fast paced environment.

• Best in class attitude; challenges status quo constructively and contributes to improvements; results oriented; ability to influence; solutions oriented mindset.

Who You Are

• 7+ years of experience with US FDA/cGMP in a pharma/biotech corporate setting and/or in a law firm or relevant government agency.

• A U.S. law degree (J.D.) and current “good standing” admission to at least one U.S. state bar, or be eligible to apply to California’s Registered In-House Counsel program.

• Demonstrated experience and track record of success or committed interest in:

  • Providing manufacturing support in pharmaceutical or biotech industries, such as regulatory counseling on FDA/cGMP related matters.

• Strong analytical, written, and oral communication skills in English; proficiency in additional European languages (e.g., German, French, Dutch) is a plus.

Location

• This role is based onsite as follows:

  • Roche’s Genentech’s South San Francisco, California campus (No remote.)

  • Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of California is$203,800 to $378,400. 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 the 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.