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Qc Stability Manager Jobs (NOW HIRING)

The QC Stability Manager is responsible for leading and supporting GMP large-molecule stability testing across all phases of client programs within QC. This role provides strategic and operational ...

The Manager, QC Stability provides leadership and strategic oversight of the stability programs from early phase through commercialized programs. This role ensures regulatory compliance, analytical ...

The Manager, QC Stability provides leadership and strategic oversight of the stability programs from early phase through commercialized programs. This role ensures regulatory compliance, analytical ...

The Manager, QC Stability provides leadership and strategic oversight of the stability programs from early phase through commercialized programs. This role ensures regulatory compliance, analytical ...

QC Stability Coordinator

Tampa, FL · On-site

$18.75 - $25.75/hr

As a QC Stability Coordinator in Tampa, you will play a critical role in managing stability programs that ensure product quality and compliance across development, clinical, and commercial stages.

QC Stability Coordinator

Tampa, FL · On-site

$18.75 - $25.75/hr

As a QC Stability Coordinator in Tampa, you will play a critical role in managing stability programs that ensure product quality and compliance across development, clinical, and commercial stages.

Stability Manager

San Carlos, CA · On-site

$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 ...

The QC Specialist III - Stability is responsible for managing and executing stability studies within the Quality Control Laboratory. This role supports GMP-compliant stability programs through study ...

Data management to support the Stability Programs including the administration and distribution of Quality Control (QC) stability samples, associated document coordination, and collection and ...

$25.50 - $34.50/hr

As a QC Analyst, you will also support global GMP stability programs through a variety of operational and technical activities, including sample set downs, pulls, shipments, data trending and ...

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Qc Stability Manager information

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$30.5K

$81.3K

$129.5K

How much do qc stability manager jobs pay per year?

As of Jun 8, 2026, the average yearly pay for qc stability manager in the United States is $81,324.00, according to ZipRecruiter salary data. Most workers in this role earn between $60,500.00 and $100,000.00 per year, depending on experience, location, and employer.

What are the typical challenges faced by a QC Stability Manager in coordinating stability studies across multiple products?

QC Stability Managers often encounter challenges in managing multiple stability studies simultaneously, particularly when dealing with diverse product portfolios and strict regulatory timelines. Ensuring data integrity, timely sampling, and accurate documentation can be complex, especially when collaborating with cross-functional teams such as manufacturing, regulatory affairs, and quality assurance. Effective organization, proactive communication, and a strong understanding of regulatory requirements are essential for overcoming these challenges and maintaining compliance.

What are QC Stability Managers?

QC Stability Managers are professionals responsible for overseeing the stability testing programs within pharmaceutical, biotechnology, or related industries. Their primary role is to ensure that products maintain their safety, efficacy, and quality throughout their shelf life by managing stability studies, analyzing data, and ensuring compliance with regulatory guidelines. They coordinate cross-functional teams, manage documentation, and ensure that stability protocols meet industry standards. QC Stability Managers also play a crucial role during audits and regulatory submissions by providing necessary data and reports. Their expertise helps companies maintain product quality and meet both internal and external regulatory requirements.

What are the key skills and qualifications needed to thrive as a QC Stability Manager, and why are they important?

To thrive as a QC Stability Manager, you need a robust background in chemistry or pharmaceutical sciences, experience in stability testing, and a relevant degree such as a BS or MS. Familiarity with laboratory information management systems (LIMS), regulatory guidelines (ICH, FDA), and analytical testing equipment like HPLC is essential. Strong organizational, leadership, and communication skills help manage teams, timelines, and cross-functional collaborations. These skills ensure the integrity of stability programs and compliance with regulatory standards, which are critical for product quality and approval.

What is the difference between Qc Stability Manager vs Qc Analyst?

AspectQc Stability ManagerQc Analyst
CertificationsQuality certifications, stability testing trainingQuality certifications, laboratory training
Work EnvironmentLaboratory, quality control departmentsLaboratory, testing facilities
Employer & IndustryPharmaceutical, biotech, or chemical industriesPharmaceutical, biotech, or chemical industries
Primary FocusOverseeing stability programs, ensuring product shelf-lifePerforming stability testing, data analysis

The Qc Stability Manager focuses on managing stability programs and ensuring product shelf-life compliance, while the Qc Analyst conducts stability testing and analyzes data. Both roles require similar certifications and work in laboratory environments within the pharmaceutical or biotech industries, but their responsibilities differ in scope and leadership level.

What cities are hiring for Qc Stability Manager jobs? Cities with the most Qc Stability Manager job openings:
What are the most commonly searched types of Qc Stability jobs? The most popular types of Qc Stability jobs are:
What states have the most Qc Stability Manager jobs? States with the most job openings for Qc Stability Manager jobs include:

QC Stability Manager

Abzena Inc.

San Diego, CA • On-site

Full-time

Posted 3 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.
The QC Stability Manager is responsible for leading and supporting GMP large-molecule stability testing across all phases of client programs within QC. This role provides strategic and operational leadership for the QC Stability function and manages a team of QC professionals. The position requires strong experience in QC laboratory operations, stability program management, and a deep understanding of cGMP/GDP requirements.
  • Leading analytical methods support activities related to stability testing, product control programs, and reference standard management.
  • Oversee daily operations of the QC Stability function in a biopharmaceutical manufacturing environment supporting multiple products and client programs.
  • Drive continuous improvement and operational efficiency across stability workflows, systems, and processes.
  • Ensure compliant operation and maintenance of stability-related infrastructure, documentation, equipment preventive maintenance, calibration, qualification, and training programs.

Responsibilities
  • People Leadership and Lab Management:
  • Provide leadership, mentorship, and development opportunities for QC staff and associates.
  • Ensure appropriate training of personnel in technical skills, cGMP compliance, data integrity, and safety requirements.
  • Communicate departmental goals, priorities, and performance expectations to direct reports.
  • Support facility teams in ensuring timely maintenance, calibration, and qualification of laboratory instruments and equipment.
  • Stability Program and Reference Standard Management:
  • Manage and oversee stability study design, protocol development, execution, and lifecycle management.
  • Coordinate stability protocol and report authoring in accordance with ICH guidelines, internal SOPs, and quality system requirements.
  • Oversee stability study setup, including sample management, material staging, and fraction tracking.
  • Track and monitor all active stability programs, including pull schedules, testing timelines, report completion, and Stability Summary Sheet issuance.
  • Maintain accurate and current stability inventory records.
  • Lead reference standard qualification, management, retesting, and lifecycle activities.
  • Monitor inventory, testing schedules, stability requirements, and timely issuance of associated certificates.
  • Provide training and oversight for laboratory personnel supporting reference standard activities.
  • Represent QC Stability in internal meetings, client meetings, audits, and cross-functional discussions related to stability and reference standards.
  • Ensure compliant analytical laboratory support and resource planning.
  • Author and/or review deviations, investigations, CAPAs, change controls, and risk assessments related to stability and reference standard programs.
  • Support or lead investigations involving OOS, OOT, non-conformances, and laboratory events.
  • Review analytical data packages, perform data trending, and provide troubleshooting support for complex laboratory issues.
  • Partner closely with Manufacturing, Analytical Development, Tech Transfer, Regulatory, and Quality Assurance teams.
  • Support strategic planning for new equipment, staff capacity planning, organizational structure, and resource requirements.
  • Recommend and justify additional equipment, staffing, promotions, or organizational changes as needed.
  • Occasional travel may be required between Abzena sites, including San Diego, California and Bristol, Pennsylvania.

Qualifications
  • Bachelor's degree or higher in Chemistry, Biology, or related Life Sciences discipline
  • Minimum 10 years of experience in QC GMP pharmaceutical or biotechnology laboratories within a cGMP-regulated environment
  • Minimum 5-6 years of people management experience in QC laboratory settings
  • Extensive knowledge of HPLC, SDS-PAGE, ELISA, Capillary Electrophoresis (CE), cIEF (Maurice platform), UV-Vis, cell-based potency assay, and compendial methods.
  • Knowledge of ICH, EP, USP, and FDA guidelines relating to method development, qualification/validation, and stability studies.

Core Competencies:
  • Excellent written, verbal, and interpersonal communication skills
  • Strong technical writing and documentation skills
  • Proficiency in Microsoft Word, Excel, and PowerPoint
  • Strong organizational skills with ability to manage multiple priorities in a fast-paced, deadline-driven environment
  • Ability to proactively communicate risks, issues, and solutions to management
  • Strong troubleshooting, problem-solving, and decision-making skills
  • Detail-oriented with strong analytical mindset
  • Ability to work independently while collaborating effectively across teams
  • Experience supporting controlled document generation, review, and approval processes
  • Ability to draft and review Certificates of Analysis and reagent specification documents
  • Flexibility to work adjusted hours based on business needs

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. 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.