QA Operations Manager

New

Skills

CRO Experience Deviation Management EMA Guidelines FDA Regulations Investigations Packaging Batch Records Process Validation Quality Assurance (QA) Quality Control (QC) Regulatory Compliance

The Manager of QA Operations will oversee the quality assurance processes related to packaging batch records, ensuring compliance with regulatory standards and managing interactions with Contract Manufacturing Organizations (CMOs).

Key Responsibilities
  • Review and manage master and executed packaging batch records from CMOs.
  • Review process validation protocols and reports.
  • Perform quality review of events, including deviations, complaints, and investigations.
  • Manage lot release activities and ensure timely communication of packaging deficiencies to management.
  • Coordinate with CMOs for effective resolution of quality issues.
  • Conduct quarterly visits to the San Francisco office.
Required Skills & Qualifications
  • Bachelor's degree in a scientific discipline.
  • 5+ years of experience in QA or QC in biotech or CRO.
  • Strong organizational skills and the ability to multitask.
  • Knowledge of FDA, EMA, and ICH GxP regulations.
  • Experience reviewing packaging master and executed batch records.

No forms. Your profile is generated instantly.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

Share this job:

Similar Jobs

Clinical Sciences Director

Posted 26 days ago

Collaborate on study results analysis.

Support Phase I–III clinical trials.

Clinical Research Data Monitoring Drug Development EMEA Guidelines

Medical Writing Director

Posted 13 days ago

Lead and strategize the Medical & Regulatory Writing team.

Serve as a subject matter expert for key clinical documents.

Clinical Protocols Clinical Study Reports (CSRs) Document Editing eCTD Formatting

Cyber Security Analyst III

Posted 45 days ago

Support cybersecurity governance, risk, and compliance activities

Responsible for specific projects or service areas within GRC work scope

Communication Skills Cybersecurity Investigations Risk Assessment

Associate Director - Counsel

Posted 45 days ago

Handle complex sanctions and due diligence matters effectively

Develop a strategic enterprise-wide approach to sanctions compliance

Investigations Sanctions Compliance

Deputy Tech Editor

Posted 45 days ago

Edit and strategize tech content

Oversee reporters and guide sourcing

Investigations Mentoring Team Collaboration

EHS Manager - Semiconductor Plants

Posted 45 days ago

Lead EHS Management System design and improvements

Ensure ISO and legal compliance

Investigations

Compliance and Regulatory Officer

Posted 45 days ago

Manage regulatory inquiries and exams effectively

Ensure compliance with Part 40 rules

Compliance Management Investigations Leadership Regulatory Compliance

Strategic Risk Analyst

Posted 45 days ago

Monitor internal risk signals and identify trends

Conduct open-source intelligence and external scanning

Analysis Data Science Investigations Risk Management

Trust & Safety Specialist

Posted 11 days ago

Investigate reported violations of house rules.

Coordinate incident response across teams.

Clear Communication Critical Thinking Customer Support Data Analysis

Corporate Counsel Employment Litigation

New

Advise on litigation and pre-litigation matters.

Manage outside counsel and control legal costs.

Collaboration Communication Skills Contract Review Cost Control

Avionics Source Inspector

Posted 36 days ago

Perform PCBA receiving inspections on avionics systems.

Travel to supplier sites for source inspections.

Avionics Systems Cable Harness Assembly Conformal Coating Continuity Testing

AI Conversation Designer

Posted 34 days ago

Manage day-to-day chatbot intents and knowledge.

Develop and maintain taxonomy and intent architecture.

Chatbot Design Conversation Design Data Analysis Generative AI

AI Conversation Designer

Posted 34 days ago

Manage chatbot intents and knowledge updates.

Implement and oversee quality assurance programs.

Backlog Management Chatbot Design Cross-Functional Collaboration Data Analysis

RN Nurse Manager Role

Posted 25 days ago

Oversee education of clinical staff.

Lead and supervise field nursing staff.

Care Planning Clinical Education Home Care Management Licensed Practical Nurse (LPN)

AI Agent Testing Specialist

Posted 33 days ago

Design realistic evaluation scenarios for AI agents.

Create test cases simulating human tasks.

AI Ethics Data Analysis Data Annotation JavaScript

AI Agent Testing Specialist

Posted 30 days ago

Design structured test scenarios for AI agents.

Define acceptable behaviors and scoring logic for agents.

Data Analysis Data Annotation JavaScript JSON

AI Agent Testing Specialist

Posted 28 days ago

Design evaluation scenarios for AI agents.

Create test cases simulating human tasks.

Analytical Skills Data Annotation JavaScript JSON

QA Software Engineer

Posted 23 days ago

Debug software to maintain quality standards.

Develop and execute software test plans.

Networking Applications Perl Python Quality Assurance (QA)

Lead Kitchen Technician

Posted 16 days ago

Lead kitchen team operations effectively.

Ensure compliance with food safety and sanitation regulations.

Batch Documentation Food Safety Regulations Good Manufacturing Practices (GMP) Inventory Management

Salesforce QA Analyst

Posted 12 days ago

Ensure environmental health applications function correctly.

Support public health initiatives.

Agile Methodologies Automation Testing Collaboration Tools Defect Tracking

Ad Operations Associate

Posted 12 days ago

Build and launch ad experiences.

Coordinate with multiple teams for campaign execution.

Analytical Skills Digital Ad Operations Digital Ad Serving Tools Display Advertising

Programmatic Operations Manager

New

Build and configure private marketplaces in SSPs.

Collaborate with clients for DSP deal activation.

Ad Operations Analytics Campaign Optimization DSP Trafficking

QA Process Specialist

New

Oversee quality systems and audit processes.

Ensure compliance in a regulated environment.

Analytical Skills Animal Health Regulations Audit Processes Documentation Control

Head of Operations

New

Lead and optimize global studio operations.

Manage QA, legal, finance, and vendor relationships.

Budgeting Business Strategy Collaboration Tools Data Analysis

CAD Mechanical Engineering Expert

Posted 33 days ago

Seek a Master's or PhD-level expert in Mechanical Engineering.

Require strong CAD skills for technical data evaluation.

AI Data Annotation CAD Software CATIA Creo

Mechanical Engineering CAD Expert

Posted 30 days ago

Recruit a Mechanical Engineering expert.

Perform technical annotation and quality review.

AI Data Annotation CAD CATIA Creo

Mechanical Engineering CAD Expert

Posted 28 days ago

Seeking a Mechanical Engineering expert for AI data annotation.

Focus on technical evaluation and quality control of engineering datasets.

CAD CATIA Creo Data Annotation

Mechanical Engineering CAD Expert

Posted 28 days ago

To find a Mechanical Engineering expert with CAD skills.

To support AI model training through data annotation.

AI Data Annotation CAD Expertise CATIA Creo

Senior eTMF Specialist

Posted 15 days ago

Serve as the primary eTMF contact.

Manage QC and TMF document completion.

Clinical Study Operations DIA TMF Reference Model Essential Document Lists (EDLs) eTMF Management

Legal Counsel, Fintech Remote

Posted 45 days ago

Provide comprehensive legal support across business functions

Ensure compliance in commercial and product operations

Compliance Corporate Governance Regulatory Compliance

Regional Compliance Officer

Posted 45 days ago

Lead regional compliance oversight for Airtm in India.

Implement and monitor AML/CFT measures for the region.

Anti-money Laundering Audit Communication Compliance

Legal Counsel - Airtm

Posted 45 days ago

Provide legal counsel on high-profile projects

Draft and negotiate contracts with various partners

Compliance Corporate Governance Licensing Project Management

Sales Floor Leader

Posted 45 days ago

Drive sales goals, Provide exceptional customer service, Manage inventory levels, Enforce company

licies, Support store

Communication Skills Financial Acumen Interpersonal Skills Organizational Skills

AML Analyst Position

Posted 45 days ago

* Review transaction monitoring alerts * Assess adverse media and PEP alerts * Prepare SAR

Conduct due diligence for high-risk customers * Support policy drafting and compliance

Blockchain technology Due Diligence Financial Services Regulatory Compliance

Benefits Analyst Position

Posted 45 days ago

Assist in benefits administration, Drive benefits function, Ensure compliance with laws, Manage

or relationships, Collaborate with

Microsoft Excel Project Management Regulatory Compliance Vendor Management

Enterprise Risk Management Analyst

Posted 45 days ago

Develop and operationalize enterprise risk management programs

Assess and monitor enterprise-wide risks and internal controls

Analyst Communication Compliance Documentation

Senior Counsel - Employment Compliance

Posted 45 days ago

Lead global employment and compliance strategy

Spearhead Future of Work in AI

Analytical Skills Communication Communication Skills Compliance

Global Geo Expansion Manager

Posted 45 days ago

Drive global market expansion initiatives

Align regulatory and compliance strategies

Business Development Cross-functional Collaboration Excel Financial Modeling

Business Development, Crypto Equities

Posted 45 days ago

Expand tokenized equities adoption

Drive high-impact strategic partnerships

Blockchain Business Development Capital Markets Partnerships

Geo Expansion Manager Role

Posted 45 days ago

Drive global market expansion

Ensure regulatory compliance and license acquisition

Business Development Cross-functional Collaboration Excel Financial Modeling

Principal Business Development xStocks

Posted 45 days ago

Drive strategic partnerships in crypto and blockchain.

Accelerate adoption of tokenized and traditional equities.

Blockchain Business Development Capital Markets Cryptocurrency

Legal Director (Wealth)

Posted 45 days ago

Provide legal and regulatory advice for wealth management roadmap - Draft agreements and

for products - Oversee governance and risk matters - Communicate complex legal concepts - Balance

Corporate law Legal Drafting Project Management Regulatory Compliance

Channel Manager

Posted 45 days ago

Develop and communicate channel strategies tailored to education sector, Identify and recruit

gic partners, Provide training and enablement, Cultivate strong relationships, Conduct market

Contract Management Crm software G-suite Market Analysis

Safety Project Manager

Posted 45 days ago

* Ensure compliance with health and safety regulations * Lead safety initiatives on construction

es * Develop and implement safety training programs * Conduct incident investigations * Collaborate

Communication Skills Project Management Regulatory Compliance Risk Assessment

AI Insurance Project Expert

Posted 45 days ago

Evaluate and validate AI insurance outputs

Provide expert feedback on actuarial and insurance methodologies

Insurance Python R Regulatory Compliance

Remote Corporate Finance Lead

Posted 45 days ago

Manage financial planning for startup-oriented banking services

Collaborate with cross-functional teams to drive strategic decisions

Budgeting Data Analysis Excel Finance

Finance Controls Analyst Role

Posted 45 days ago

Hire remote finance analyst

Ensure internal financial controls

Analytical Skills Finance Financial Reporting Internal Controls