- Expired: over a month ago. Applications are no longer accepted.
Relocation eligible, competitive salary, great benefits right here in the “medical mecca” of the Midwest with Best in the Nation health systems: Cleveland Clinic and University Hospitals. We offer: 2 medical plans, dental, vision, company-paid + supplemental life & income replacement benefits, 401k with company match-JOIN US!!
Olon Ricerca Bioscience is seeking a Quality Assurance (QA) Manager with experience in GMP-based Quality Management Systems supporting drug substance/drug product manufacturing and characterization. Reporting to the CEO, the QA Manager will provide oversight of the Quality Management System to assure compliance and to support the manufacture and characterization of clinical and commercial products in compliance with GMP and GLP guidelines. The QA Manager will be responsible for establishing and driving Quality initiatives, maintaining/improving quality infrastructure and quality oversight of operational activities.
MAJOR ACTIVITIES AND RESPONSIBILITIES
- Overall responsibility for Quality Management System
- Oversight of quality documentation review and approval including quality agreements, project protocols, validation plans, batch records and associated analytical data related to the manufacture and characterization of drug substances and drug products
- Responsible for the disposition of drug substances and drug products
- Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy and logic of root cause analysis, and impact to both quality and regulatory commitments.
- Responsible for internal audits, supplier/material qualification, archives, training, document control, and data integrity.
- Administration of Exception Management System for investigations, deviations, and CAPAs
- Management of a 3 to 5 person QA staff
- Manage inspections by Regulatory Authorities & Clients
Skills & Educational Requirements
- BS or equivalent in a technical discipline and a minimum of 7 years of experience of in the pharmaceutical/ biotech industry
- Five (5) years of experience in Quality Assurance supporting manufacturing and characterization of drug product/drug substance for clinical and commercial use
- Knowledge and technical understanding of the manufacture and testing of small molecule drug substance and drug product
- Knowledge of GMP and GLP principles with respect to FDA and EMA regulations and guidelines
- Familiarity with drug development process
- Experience in exception management including deviation investigations, root cause analysis, risk assessment and developing corrective action plans
- Experience in data integrity / 21CFR Part 11 Compliance
- Experience is process validation, analytical method validation and equipment qualification
- Excellent communication and documentation skills
- Experience in mentoring and management of staff
We offer a competitive salary along with a comprehensive benefit plan and a great workplace with really smart people, so join us!
Olon Ricerca Bioscience LLC. is an Equal Opportunity employer and makes all employment decisions without regard to race, religion, color, national origin, and ancestry, known or perceived disability, age, marital status, pregnancy or other medical condition, sex (including, pregnancy, sexual orientation and gender identity), genetic information, veteran status, or any other status protected under applicable federal, state, or local laws
Olon Ricerca Bioscience LLC
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