Senior Specialist, Supplier Quality

Location: Fully remote; can be performed effectively from anywhere. Occasional travel for team meetings or events and frequent domestic/international travel of up to 30% are expected.

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Lead the drafting, review, negotiation, execution, renewal, revision, and retirement of Quality Technical Agreements with suppliers, contract manufacturers, and service providers.
• Partner with Legal, Procurement, Manufacturing, Regulatory Affairs, Quality Control, and other subject matter experts to align agreement responsibilities with regulatory requirements.
• Conduct routine, for-cause, and qualification GMP audits as Lead Auditor, including meetings, evidence gathering, reporting, and corrective-action follow-up.
• Support supplier qualification and requalification through risk assessments, questionnaires, approvals, scorecards, and KPI monitoring.
• Maintain supplier GMP certificates and quality documentation, and support health authority inspections and regulatory audits.
• Identify gaps between agreement terms and operational practice and drive resolution with internal and external stakeholders.

Requirements

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related discipline.
• 10–12 years of progressively responsible Quality Assurance or Supplier Quality experience in biotech or pharma, including Quality Agreement authoring, negotiation, and lifecycle management.
• Direct experience leading GMP audits of suppliers, contract manufacturers, or service providers.
• Thorough knowledge of global drug cGMPs, ISO 13485, and requirements for drug product, medical device, and combination product manufacturing.
• Working knowledge of deviation management, CAPA, change control, and document control, along with proficiency in data analytics, critical thinking, and decision-making.
• Strong negotiation and communication skills with the ability to influence and collaborate across functions and organizations.

Nice to have

• ASQ Certified Quality Auditor certification or similar.

Culture & Benefits

• Fully remote work with purposeful in-person collaboration and team connection.
• Medical, dental, and vision coverage, mental health support, wellbeing reimbursement, and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning opportunities through LinkedIn Learning, workshops, leadership programs, mentorship, networking, and employee resource groups.