QA Manager-Site Compliance - Permanent - White Plains, NY
Proclinical is seeking a QA Manager-Site Compliance for a global mid-sized consumer healthcare and medical devices company. This is a permanent role based at the company's manufacturing site in New York.
Primary Responsibilities:
In this role, you will be responsible for the site Quality compliance activities and the implementation, management, and monitoring of the performance of the Quality Management System (QMS). This position will ensure cGMP, GDP, and Data Integrity training is conducted at appropriate intervals. This position has the responsibility and authority for the implementation and effectiveness of the QMS internal and external audit program in alignment with Pharmaceutical Good Manufacturing Practices 21 CFR 210/211, FDA Medical Device Good Manufacturing Practices 21 CFR 820/ISO 13485, Health Canada, and ICH.
Skills & Requirements:
- Bachelor's degree in a scientific discipline is required. Advanced degree is preferred.
- At least five years of experience in pharmaceutical and/or medical device quality compliance.
- At least three years of people leadership experience.
- Experience leading/managing US FDA regulatory inspections, organizing and facilitating to close Quality-related audits and CAPA, OOS and cGMP experience required.
- Must be eligible to work in the US.
The QA Manager-Site Compliance will:
- Accountable for strategic leadership, development, and implementation of the Internal and External Audit cGMP QA System for drug/device products.
- Support the development and maintenance of a qualification/certification program for Internal/external auditors.
- Collaborate with Subject Matter Experts (SMEs) to conduct external audits on suppliers, laboratories, and third-party manufacturers as required.
- Ensure associated internal or external corrective action is completed within required timeframes.
- Ensure that CAPAs generated to address Internal Audit findings are audited for effectiveness. Monitor and report the effectiveness of Internal Audits including CAPA plans, effectiveness checks, and risks.
- Accountable for annual cGMP, GDP, and Data Integrity Training.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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