ZipRecruiter

Log In

1

Quality Control Stability Manager Jobs in California

Abzena Inc.

QC Stability Manager

San Diego, CA · On-site

$120K - $150K/yr

As the QC Stability Manager , you will lead a high-performing Quality Control team responsible for ensuring the integrity, reliability, and regulatory compliance of stability programs and reference ...

Vaxcyte

Stability Manager

San Carlos, CA

$147K - $171K/yr

Primary responsibility will include managing stability studies for individual projects and ... This individual will collaborate with QC members in a highly collaborative and cross-functional ...

Vaxcyte

Stability Manager

San Carlos, CA · On-site

$134K - $162K/yr

Primary responsibility will include managing stability studies for individual projects and ... This individual will collaborate with QC members in a highly collaborative and cross-functional ...

Unicon Pharma Inc.

QC Analyst I - Vacaville, CA

Vacaville, CA · On-site

$27.25 - $36.50/hr

With limited supervision, QC Stability Study Coordinator, is responsible for the oversight of stability program management in accordance with cGMP regulations. * These duties include execution of ...

TekWissen LLC

QC Analyst I

Vacaville, CA · On-site

$20 - $25/hr

Onsite Summary The QC Stability Study Coordinator I is responsible for overseeing stability program management in compliance with cGMP regulations, with limited supervision. This role includes ...

Abzena Inc.

QC Manager

San Diego, CA · On-site

$120K - $150K/yr

Stability studies (ICH-compliant programs) * Testing associated with Qualification/Validation of ... Minimum 5-6 years of people management experience in QC laboratory settings * Extensive knowledge ...

Orca Bio

Manager, Quality Control

Sacramento, CA

The Manager, Quality Control is responsible for providing oversight for the GMP testing of cell ... stability testing of clinical and commercial cell therapy products. Perform data reviews and ...

Orca Bio

Manager, Quality Control

Sacramento, CA · On-site

The Manager, Quality Control is responsible for providing oversight for the GMP testing of cell ... stability testing of clinical and commercial cell therapy products. Perform data reviews and ...

Grifols

QC Lead

Emeryville, CA

The lead will assist the Supervisor or QC Manager with the day-to-day operation of one of the ... Antigen stability program * Seed Stock stability program * Equipment/eSystems/calibration ...

GRIFOLS, S.A.

QC Lead

Emeryville, CA · On-site

The lead will assist the Supervisor or QC Manager with the day-to-day operation of one of the ... Antigen stability program * Seed Stock stability program * Equipment/eSystems/calibration ...

next page

Showing results 1-20

All JobsQuality Control Stability Manager JobsQuality Control Stability Manager Jobs in California

Quality Control Stability Manager information

What are popular job titles related to Quality Control Stability Manager jobs in California? For Quality Control Stability Manager jobs in California, the most frequently searched job titles are:
What job categories do people searching Quality Control Stability Manager jobs in California look for? The top searched job categories for Quality Control Stability Manager jobs in California are:
What cities in California are hiring for Quality Control Stability Manager jobs? Cities in California with the most Quality Control Stability Manager job openings:
Quality Control Stability Manager jobs near you

QC Stability Manager

Abzena Inc.

San Diego, CA • On-site

$120K - $150K/yr

Full-time

Posted 23 days ago

Job description

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
As the QC Stability Manager, you will lead a high-performing Quality Control team responsible for ensuring the integrity, reliability, and regulatory compliance of stability programs and reference standard management across Abzena's biopharmaceutical operations. This role blends scientific expertise, operational leadership, and cross-functional influence - ideal for a seasoned QC leader who thrives in a fast-paced, growth-oriented environment.
Responsibilities
People Leadership & Laboratory Excellence
  • Lead, mentor, and develop QC scientists and associates, fostering a culture of technical excellence, accountability, and continuous improvement.
  • Ensure all personnel are fully trained in technical competencies, cGMP, data integrity, and laboratory safety.
  • Communicate clear goals, priorities, and performance expectations to direct reports.
  • Partner with facilities teams to maintain a state of control for laboratory equipment, including calibration, qualification, and preventive maintenance.
  • Drive operational readiness and resource planning to support analytical testing needs.
Stability Program Ownership
  • Oversee end-to-end stability program management, including study design, protocol development, execution, and lifecycle oversight.
  • Ensure all stability protocols and reports meet ICH, internal SOP, and quality system requirements.
  • Manage sample logistics, material staging, and tracking for all stability studies.
  • Monitor active stability programs, ensuring on-time pulls, testing, reporting, and issuance of Stability Summary Sheets.
  • Maintain accurate, audit-ready stability inventory and documentation.
Reference Standard Strategy & Oversight
  • Lead qualification, lifecycle management, retesting, and documentation for reference standards.
  • Oversee inventory, testing schedules, stability requirements, and timely issuance of certificates.
  • Train and guide laboratory personnel supporting reference standard activities.
  • Represent QC Stability in internal meetings, client interactions, audits, and cross-functional forums.
Quality, Compliance & Technical Support
  • Author or review deviations, investigations, CAPAs, change controls, and risk assessments related to stability and reference standards.
  • Support or lead investigations involving OOS, OOT, non-conformances, and laboratory events.
  • Review analytical data packages, perform data trending, and troubleshoot complex laboratory issues.
  • Collaborate closely with Manufacturing, Analytical Development, Tech Transfer, Regulatory, and Quality Assurance teams.
Strategic Planning & Organizational Growth
  • Contribute to long-term planning for equipment, staffing, and organizational structure.
  • Recommend and justify new equipment, headcount, promotions, and process improvements.

Qualifications
  • Bachelor's degree or higher in Chemistry, Biology, or related Life Sciences discipline.
  • 10+ years of QC experience in GMP pharmaceutical or biotechnology laboratories.
  • 5-6+ years of people management experience in QC laboratory environments.
  • Deep expertise with analytical platforms including HPLC, SDS-PAGE, ELISA, Capillary Electrophoresis, cIEF (Maurice), UV-Vis, cell-based potency assays, and compendial methods.
  • Strong working knowledge of ICH, USP, EP, and FDA guidelines related to method development, validation, and stability studies.

Physical Requirements
  • Frequently lift and or move objects up to 20 pounds.
  • Stand/walk during entire length of shift.
  • Use of arms, hands and fingers to handle, feel or reach.
  • Ability to climb, balance, stoop, kneel, crouch, or crawl.
  • Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus.

$120,000 - $150,000 a year
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local Jaws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Apply