RemoteLeaf Logo
Log in Sign up

Manager, QA Operations

2 months ago
United States
Full-time
Senior
Manual QA Tester
Quality Assurance and Testing
Apply Now
bridgebiowp

bridgebiowp

bridgebiowp is a biotechnology firm focused on designing transformative medicines specifically for patients suffering from genetic diseases and cancers that have identifiable genetic drivers.

Pharmaceuticals
251-1K
Founded 2014
$2300M raised
View All Jobs 20

Description

  • Serve as the quality lead for commercial packaging operations at assigned contract service providers.
  • Provide oversight of primary and secondary packaging, labeling, and serialization to ensure GMP and GDP compliance.
  • Review executed batch records and compile batch documentation packages to support lot disposition and market release.
  • Provide quality review of deviations, change controls, CAPAs, and risk assessments related to packaging operations.
  • Review tech transfer, process validation, and shipping qualification protocols and reports through preparation, execution, and closure.
  • Communicate and escalate manufacturing deficiencies and non-conformances, and work with CMOs to drive timely resolution.
  • Support review of CMC sections and regulatory filings.
  • Author, review, and maintain QA Operations SOPs and controlled documents.

Requirements

  • Bachelor’s degree in a scientific discipline.
  • 6+ years of experience within a biopharmaceutical company.
  • 4+ years of experience in Quality Operations roles in a cGMP environment.
  • Strong working knowledge of FDA regulations, including 21 CFR 210/211.
  • Knowledge of ICH guidelines and global regulations, including EU Directives and ROW requirements.
  • Expertise in cGMP requirements for manufacturing and packaging operations, including serialization, in the U.S. and globally.
  • Experience with the Veeva platform is highly preferred.
  • Strong communication and collaboration skills with the ability to influence stakeholders in a matrix environment.
  • Ability to exercise good judgment and make decisions aligned with organizational objectives.
  • Up to 15% domestic and international travel required.

Benefits

  • Market-leading compensation with a salary range of $135,700 to $175,000 USD.
  • Annual performance bonus.
  • Company equity and Employee Stock Purchase Program (ESPP).
  • 401(k) with employer match.
  • 100% employer-paid medical, dental, and vision premiums for employees and dependents.
  • Health Savings Account (HSA) with annual employer contributions plus Flexible Spending Accounts (FSA).
  • Flexible, hybrid work model with in-office collaboration 2-3 times per week or quarterly/as-needed office visits for remote employees.
  • Flexible take-what-you-need paid time off, company-paid holidays, paid medical leave, and parental leave.
  • Subsidized lunch and parking on in-office days.
  • Expanded mental health support, including therapy and coaching resources.
  • Fertility and family-forming benefits.
  • Career development support through regular feedback, LinkedIn Learning, LifeLabs, and BetterUp coaching.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

ShipMonk

Operations Manager

ShipMonk 1K-5K Air Freight & Logistics

ShipMonk is hiring an Operations Manager to lead fulfillment center operations and teams across its expanding ecommerce logistics network, driving safety, quality, productivity, and continuous improvement.

United States Full-time Senior Operations Manager
E-commerce ERP Tableau
2 hours, 56 minutes ago
Cision

IT Operations Manager

Cision 5K-10K Professional Services

Cision is seeking an IT Manager to lead global enterprise collaboration and productivity platforms, overseeing operations, governance, support, and continuous improvement for the tools and services that enable modern workplace communication.

Bulgaria Full-time Lead Operations Manager
JIRA OpenID Connect PowerShell SAML
2 hours, 56 minutes ago
Quince

QC Manager, Apparel (China)

Quince 51-250 Textiles, Apparel & Luxury Goods

Quince is hiring a QC Manager, Apparel to oversee factory quality control for a rapidly scaling direct-to-consumer retail business focused on sustainable, high-quality essentials.

China Full-time Lead Manual QA Tester QA Engineer
3 hours, 11 minutes ago
HelloFresh

[US-HQ] Vice President, Automation and Engineering

HelloFresh 10K-50K Hotels, Restaurants & Leisure

Vice President, Automation and Engineering at HelloFresh leads supply chain automation, engineering, and infrastructure efforts to improve fulfillment center performance across North America.

United States Full-time Executive Operations Manager Program Manager
Agile JIRA
3 hours, 11 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers