13 часов назад
Senior Supplier Quality Specialist (Biopharma)
100 000 - 126 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Supplier Quality Specialist (Biopharma): Managing Quality Technical Agreements and leading GMP audits for suppliers, contract manufacturers, and service providers with an accent on supplier qualification, regulatory compliance, and quality risk management. Focus on negotiating QTA terms, evaluating corrective actions, supporting inspections, and maintaining supplier readiness across drug, medical device, and combination product operations.
Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events is expected, with frequent domestic and international travel of up to 30%.
Salary: $100,000–$126,500 annual.
Company
is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.
What you will do
- Own the full lifecycle of Quality Technical Agreements with suppliers, contract manufacturers, and service providers.
- Draft, review, and negotiate QTA terms with Legal, Procurement, Manufacturing, Regulatory Affairs, Quality Control, and external suppliers.
- Lead routine, for-cause, and qualification GMP audits, including meetings, evidence gathering, reporting, and corrective-action follow-up.
- Support supplier qualification and requalification through risk assessments, questionnaires, approvals, and performance monitoring.
- Maintain supplier GMP certificates, quality documentation, QTA trackers, and supplier scorecards for inspection readiness.
- Support Health Authority inspections and internal or external regulatory audits as a supplier quality subject matter expert.
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.
- Direct experience authoring, negotiating, and managing Quality Agreements and leading supplier GMP audits.
- 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.
- Strong negotiation, communication, data analytics, critical-thinking, decision-making, and cross-functional collaboration skills.
Nice to have
- ASQ Certified Quality Auditor certification or equivalent.
Culture & Benefits
- Fully remote work with connection to the team and community.
- 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 programs, LinkedIn Learning, workshops, mentorship, employee resource groups, and service opportunities.
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