BridgeBio

Manager, Quality Operations, ROW Distribution

BridgeBio

full-time

Posted on:

Location Type: Remote

Location: Netherlands

Visit company website

Explore more

✨ AI Apply
Apply

Tech Stack

ERP

About the role

  • The Quality Operations Manager for ROW Product Distribution reports directly to the Senior Manager of Quality Assurance at BridgeBio Netherlands. This role is responsible for ensuring that distributed products consistently meet all applicable regulatory and internal standards throughout the entire distribution lifecycle.
  • Key duties include overseeing quality from product release through customer delivery, evaluating distribution deviations and conducting investigations, and facilitating collaboration with suppliers and internal teams such as Quality Control, Manufacturing, Regulatory Affairs, and Supply Chain. The position demands exceptional analytical, organizational, and communication abilities.
  • Manage batch release activities for distribution and communication of batch release schedules to key stakeholders.
  • Ensure that required licenses at the distributors are available and current.
  • Ensure Distributors are set-up in company’s approved list.
  • Create, review and approve certificate of analysis applicable for specific markets.
  • Ensure the quality and integrity of product during storage, transportation, and distribution.
  • Ensure compliance with packaging requirements.
  • Perform quality review and guide quality events (deviations, change requests, distributor notifications, etc.) as documented by contract distributors.
  • Communicate distribution deficiencies/non-conformances to management and work with internal stakeholders and distributors to ensure timely resolution.
  • Participate in the GDP/GMP qualification and audit of Distributors.
  • Collaborate with the third-party logistics (3PL) providers to ensure they meet quality expectations.
  • Participate in regulatory inspections at the Distributors as needed.
  • Monitor Distributor performance using statistical analysis to report on key performance indicators (KPIs) and quality metrics to management.
  • Participate as QA person-in-plant, internal, and external meetings.
  • Write and review SOPs and quality assurance procedures.

Requirements

  • Bachelor’s degree or equivalent in operations, science, supply chain, engineering required
  • Prior experience with a commercial product
  • Prefer experience in oversight of external vendors and customers
  • Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers
  • Ability to interact successfully in a diverse environment
  • Strong analytical and organizational skills
  • Ability to engage in cross-functional interactions with internal and external staff
  • Strong planning and time management skills with the ability to prioritize workload
  • Proficiency in document and presentation office tools (Microsoft Office, Excel, etc.)
  • Basic understanding of data concepts and enterprise resource planning (ERP) systems
  • Ready to embrace companies’ core values and diverse corporate culture
  • Minimum 6 years of experience (or 3 years with Master’s Degree) in quality assurance, distribution, logistics role in the pharmaceutical industry
  • Extensive knowledge of regulations, guidelines and standards related to cGMPs (CFR/ICH/EMA), and distribution (GDP) of medicinal products.
Benefits
  • Market leading compensation
  • Hybrid work model - we value your flexibility in how you work, but encourage time in the office to strengthen our culture, collaboration, and sense of community
  • We provide career development through regular feedback, continuous education and professional development programs
  • We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality assurancestatistical analysisbatch release managementSOP writingregulatory compliancequality metricsdeviation managementchange request managementcertificate of analysis reviewGDP/GMP qualification
Soft Skills
analytical skillsorganizational skillscommunication skillscross-functional collaborationplanning skillstime managementinterpersonal skillsproblem-solving skillsadaptabilitycultural awareness