External QA Manager

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 remotely

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 escalate 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