4 дня назад
Quality Assurance Manager (Pharmaceutical)
105 000 - 135 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Quality Assurance Manager (Pharmaceutical): Leading quality assurance and product oversight for pharmaceutical manufacturing, with an accent on cGMP compliance, product release, audits, regulatory inspections, and quality systems. Focus on approving deviations, investigations, CAPAs, change controls, and validation documentation while driving inspection readiness and supervising QA/QS specialists.
Location: Pennsville, New Jersey, United States; onsite role
Salary: $105,000–$135,000 per year
Company
is a global pharmaceutical CDMO with 16 sites across three continents, developing and manufacturing APIs and finished dosage forms.
What you will do
- Lead quality decisions, product oversight, final product release, and customer quality communication.
- Direct QA resources and workflows with Production and Shipping while supervising 5–10 QA/QS Specialists.
- Lead customer and internal audits, author audit responses, and ensure CAPA completion.
- Manage regulatory inspection readiness, information flow, responses, and risk-mitigation strategies.
- Review and approve change controls, deviations, investigations, CAPAs, SOPs, production records, logs, and product quality reviews.
- Drive GMP compliance, quality systems, validation activities, continuous improvement, training, and environmental monitoring.
Requirements
- Bachelor’s degree in Chemistry, Chemical Engineering, or an equivalent technical field, and/or 5–10 years of pharmaceutical quality assurance experience.
- Two to five years of leadership experience with responsibility for staffing, performance management, and training.
- In-depth knowledge of cGMP in a manufacturing environment.
- Excellent verbal and written communication, coaching, interpersonal, and project management skills.
- Ability to work effectively with people at all levels and across cultures; conscientious, detail-oriented, self-starting, and collaborative.
Culture & Benefits
- Performance-based bonus and Employee Share Matching Plan.
- 401(k) match.
- Medical, dental, and vision insurance.
- Life, sickness, accident, and long-term disability insurance.
- Optional increased voluntary life insurance for employees and families.
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