4 дня назад
Manager, QA Compliance (Pharmaceuticals)
135 000 - 142 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, QA Compliance (Pharmaceuticals): Supporting supplier management, internal audit, and quality agreement programs in a regulated pharmaceutical environment with an accent on GMP, regulatory compliance, and quality systems. Focus on coordinating supplier qualification, conducting audits, managing CAPA and quality agreement workflows, and maintaining compliance databases.
Location: Hybrid role in Melrose Park, Illinois; onsite three days per week. Applicants must be authorized to work for any employer in the United States.
Salary: $135,000–$142,000 per year, based on experience.
Company
develops and provides pharmaceutical and healthcare products in regulated markets.
What you will do
- Coordinate supplier management activities, including supplier qualification, risk assessments, audits, documentation, reports, and approved vendor list maintenance.
- Support regional and global supplier tracking databases and investigate supplier change notifications through closure.
- Plan, prepare, and conduct internal audits as a lead or co-auditor, including audit reports, CAPA reviews, and closure activities.
- Coordinate, negotiate, review, and finalize supplier and inter-company quality agreements.
- Prepare monthly management review materials and coordinate supplier data for product APQR activities.
- Support inspections, process improvements, annual supplier evaluations, and the Senior Manager as a backup.
Requirements
- Bachelor’s degree in a science discipline.
- 8+ years of progressive QA/QC experience in the pharmaceutical industry or another regulated industry.
- In-depth knowledge of current GMP and related quality systems.
- Strong leadership, communication, interpersonal, negotiation, and problem-resolution skills.
- Ability to manage multiple priorities independently with minimal supervision.
- Effective spoken and written English is required for policies, procedures, training materials, and workplace communications.
Culture & Benefits
- 401(k) plan with company contributions.
- Medical, prescription drug, dental, and vision coverage.
- Paid vacation, holidays, and personal days.
- Life insurance, disability coverage, employee assistance program, and wellness program.
- Position is eligible for a bonus plan with a target of 10% of base salary.
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