External QA Manager

Team Horizon; Dublin; Remote; EUR 80,000 - 100,000; Full time

Job summary

A leading biotech company is seeking an External QA Manager to provide quality and compliance oversight, primarily on a remote basis. The ideal candidate will have over 10 years of experience in the biotech or pharmaceutical industry, particularly in Aseptic Manufacturing, and possess strong project management and analytical skills. This role offers flexibility and the chance to impact quality standards at contract labs and CMOs.

Qualifications

• 10+ years of experience in the biotech or pharmaceutical industry.
• Ability to negotiate and influence senior stakeholders.
• Demonstrated ability to lead cross-functional teams.

Responsibilities

• Ensure Quality and Compliance Oversight of CMOs.
• Lead preparation for Regulatory Inspections.
• Review and approve Master Batch Records.

Skills

Quality experience at Aseptic Manufacturing facilities

Strong project management skills

Analytical skills

Problem-solving skills

Job description

Team Horizon is seeking an External QA Manager on a primarily remote basis. In this role you will have Quality and Compliance Oversight of CMOs.

Why you should apply:

• This is an excellent opportunity to join a fast paced and diverse team, in a company who are committed to discovering, developing, & manufacturing innovative human therapeutics
• Opportunity to leverage your strong quality mindset across deviation management, reg affairs, filings, regulatory guidance in an external manufacturing role
• Flexibility to work remote

What you will be doing:

• Quality and Compliance Oversight of a contract lab, CMO or a raw material SRE. Alignment with CTA / Marketing Application.
  Key Responsibilities
• Be an integral quality member of cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.
• Negotiator and Approver of quality agreements
• Lead the preparation of the site and represent company at product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required.
• Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
• Review / Approve Master Batch Records
• Quality approver for deviations, change controls, CAPA
• Prepare inspection playbooks
• Identify and mitigate Risk at the CMO or testing Laboratories and/or elevate to management
• Perform Person in Plant activities as required
• APR Data Provider
• Manage Audit commitments to completion
• Perform tactical batch disposition activities in support of lot release
• Release or Reject batches/ Approve or reject deviations, Change Control, CAPA
• Provide Quality position on GMP related topics and strategy for the site
• Decision to approve Master batch Records/Raw Material Specifications

What you need to apply:

• 10 + years biotech or pharmaceutical industry experience
• Significant Quality experience at Aseptic Manufacturing facilities
• Able to facilitate and influence senior stakeholders and partners
• Able to successfully manage workload and timelines
• Familiarity with basic project management tools
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Strong project management, problem-solving, and analytical skills
• Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
• Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution