Top 148 Quality manager Jobs in Berkeley, Ca

Senior Manager, CMC QA
Ultragenyx Pharmaceutical —South San Francisco, CA
- $174,900 - $216,100 a year
- Full-time
- Hybrid work
- 7 years
- Bachelor's degree
- Team management
- Gym membership
6d
Senior Manager, CMC QA
Ultragenyx Pharmaceutical —Novato, CA
- $174,900 - $216,100 a year
- Full-time
- Hybrid work
- 7 years
- Bachelor's degree
- Team management
- Gym membership
6d
Quality System Manager
ZEISS Group —Dublin, CA
- $132,200 - $165,300 a year
- Full-time
- Bachelor's degree
- Team management
- Mentoring
- Health insurance
- Dental insurance
3d
Manager, Quality & Safety
Fictiv —Oakland, CA
- $125,000 - $140,000 a year
- Remote
- Bachelor of Science
- Engineering
- Travel
- Health insurance
- Dental insurance
Quick Apply
Senior Manager, Quality Systems - Lingo (on-site)
Abbott Laboratories —Alameda, CA
- $130,700 - $261,300 a year
- Full-time
- 7 years
- Bachelor's degree
- Recruiting
- Health insurance
- Tuition reimbursement
Quality Assurance Manager, Home
Quince —San Francisco, CA
- $130,000 - $155,000 a year
- Background check
- Team management
- Senior level
Sr Program Manager, Quality Management, GES NA D&C, Quality Management
Amazon.com Services LLC —San Francisco, CA
- $104,100 - $185,000 a year
- Full-time
- 5 years
- Engineering
- Office
- AD&D insurance
- Relocation assistance
Supplier Quality Manager
Atomic Machines —Emeryville, CA
- $150,000 - $200,000 a year
- 6 years
- Engineering
- ERP systems
Quick Apply
9d
Quality Manager
SirenOpt —San Leandro, CA
- $160,000 - $190,000 a year
- Bachelor of Science
- Supervising experience
- Team management
- Paid holidays
- Health insurance
Sr. Manager, Tech Quality Assurance – Lingo (on-site)
Abbott Laboratories —Alameda, CA
- $130,700 - $261,300 a year
- Full-time
- Mentoring
- Software development
- Experience equivalent to degree accepted
- Health insurance
- Tuition reimbursement
Senior Manager, Analytical Quality Control
Septerna —San Francisco, CA
- $175,000 - $195,000 a year
- 5 years
- Bachelor of Science
- Bachelor's degree
Quality Manager - Aerospace and Defense
Attalon, Inc. —Richmond, CA
- $114,375 - $202,500 a year
- Full-time
- Office
- 3 years
- Supervising experience
Quick Apply
Quality Improvement Manager
Asian Health Services —San Leandro, CA
- $125,000 - $135,000 a year
- Full-time
- Nursing
- Clinic
- Analysis skills
- Commuter assistance
- Paid holidays
Quick Apply
8d
Supervisor Complaint Handling
Abbott Laboratories —Alameda, CA
- $100,000 - $200,000 a year
- Full-time
- Mid-level
- Bachelor's degree
- Mentoring
- Health insurance
- Tuition reimbursement
Senior Manager, Quality Assurance
Vera Therapeutics, Inc. —Brisbane, CA
- $140,000 - $190,000 a year
- 6 years
- Master's degree
- Bachelor's degree
- Paid holidays
- Health insurance
Capital Projects, Quality Manager
Sila —Alameda, CA
- $151,000 - $191,000 a year
- 7 years
- Construction site
- Engineering
Program Manager, Localization Testing
Meta —San Francisco, CA
- $132,000 - $189,000 a year
- 8 years
- Contracts
- Fair chance
Manager, Test Automation
Abbott Laboratories —Alameda, CA
- $130,700 - $261,300 a year
- Full-time
- Computer science
- Management
- Computer Science
- Health insurance
- Tuition reimbursement
R&D Quality Manager
Deloitte —San Francisco, CA
- $155,600 - $306,800 a year
- Full-time
- Up to 50% travel
- 3 years
- Bachelor's degree
Director of Quality
Attalon, Inc. —Richmond, CA
- $152,145 - $262,423 a year
- Full-time
- Engineering
- Senior level
- Business
Quick Apply

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Senior Manager, CMC QA

Ultragenyx Pharmaceutical -
South San Francisco, CA

Apply Now

Job Details

Full-time
$174,900 - $216,100 a year
6 days ago

Benefits

Gym membership

Qualifications

GAMP
Clinical development
FDA 21 CFR Part 11
Project management experience in manufacturing
Production validation processes
Bachelor's degree
Team management
Release management
Quality assurance experience within pharmaceutical industry
Conflict management
Schedule creation
Regulatory submissions
Managing projects
Regulatory compliance analysis

Full Job Description

Why Join Us?

Be a hero for our rare disease patients

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

The Senior Manager, CMC QA will report to the Sr Director, CMC Quality Assurance. This role supports UGX QA Lot Disposition team performing tasks related to disposition and documentation activities for UGX and UGT product lots. This position is responsible for oversight and management of the Lot Release system, working proactively and cross-functionally to ensure lots are released according to schedule and Patient need.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

Work proactively with TechOps planning function, to ensure lot release dispositions are clearly and appropriately scheduled.

Work proactively to schedule and facilitate Production Planning meetings to ensure complete planning for production and subsequent lot release.

Ensure review CMO executed manufacturing batch records per QA SOPs, according to schedule and internal KPI requirements

Ensure Certificate of Analysis documents are evaluated and found to be accurate by QC group.

Understand QA systems such as raw material disposition, deviations, and change control to ensure batch records are compliant with these systems.

Ensure batch record history files are compiled and KPIs are updated and current.

Apply disposition to lots of material manufactured for Clinical, Early Access, and Commercial use. This includes, but not limited to, Starting Materials, DS, DP, FG.

Ensures archival of completed and reviewed manufacturing batch records

Drive change control accuracy, completeness, and transparency through the Change Review Forum

Perform the Change Control QA Role, where needed

Identify opportunities for improvement in Lot Release and Change Control, and use continuous improvement tools to drive implementation of improvements

Perform QMS data collection and trending for all APQR activities

Plan and coordinate cross-functional meetings with QP/QO/RP.

Other duties as assigned.

For DS/DP, ability to be authorized to assign lot disposition (releases lots)

Requirements:

Bachelor's degree in a science or related technical field with no less than 7 years relevant industry experience

Working knowledge of desktop computers

Demonstrated ability for detail-oriented work

This individual must exhibit strong compliance, organization, and communication skills.

In depth knowledge of pharmaceutical regulations including 21 CFR Part 11, GMPs, GCPs, GAMP 5, and Annex 11.

Extensive experience in managing multiple validation projects, developing plans, managing to project schedules and directing vendor/contract resources in creating CSV deliverables.

Diverse experience validating GxP-regulated applications for quality management, regulatory submissions, controlled document management solutions and clinical development

Must possess excellent communication, conflict resolutions, influence and problem-solving skills.

Deep understanding of the validation methodologies applied to on-prem applications and hosted environment.

Strong attention to detail, quality oriented

Must be self-motivated and comfortable in a fast-paced, demanding and dynamic work environment.

#LI-KJ1 #LI-Hybrid

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

Generous vacation time and public holidays observed by the company

Volunteer days

Long term incentive and Employee stock purchase plans or equivalent offerings

Employee wellbeing benefits

Fitness reimbursement

Tuition sponsoring

Professional development plans

Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: [email protected].

Apply Now

Refine Your Search

quality manager jobs in berkeley, ca

Senior Manager, CMC QA

Senior Manager, CMC QA

Quality System Manager

Manager, Quality & Safety

Senior Manager, Quality Systems - Lingo (on-site)

Quality Assurance Manager, Home

Sr Program Manager, Quality Management, GES NA D&C, Quality Management

Supplier Quality Manager

Quality Manager

Sr. Manager, Tech Quality Assurance – Lingo (on-site)

Senior Manager, Analytical Quality Control

Quality Manager - Aerospace and Defense

Quality Improvement Manager

Supervisor Complaint Handling

Senior Manager, Quality Assurance

Capital Projects, Quality Manager

Program Manager, Localization Testing

Manager, Test Automation

R&D Quality Manager

Director of Quality

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