Quality Assurance Manager Job

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A reputable CDMO is currently looking for a Quality Assurance Manager
in the Cleveland area. The company is a leader in Active Pharmaceutical Ingredients (APIs) production. They process and service drug substances for biotech and pharma.
This position will report to the CEO and manage a team of 3-5. Small molecule API experience will be key. You will provide oversight of the QMS to assure compliance and support the manufacture and characterization of clinical and commercial products in compliance with GMP and GLP guidelines.
Excellent Pay, Benefits and Relocation package
Opportunity to work in the Medical Mecca (Cleveland Clinic) with some of the best in the Nation
Small company (100-150) where your contributions and impact are noticed
Direct access to CEO
This is an opportunity to grow in a company that is progressing drug candidates through all phases of development.
Quality Assurance Manager
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
Quality Assurance Manager Requirements:
BS or equivalent in a technical discipline and a 7 years of experience of in the pharmaceutical/biotech industry
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
For additional information on this opportunity, ****.
You can email me directly at: ****
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (**MEMBERS ONLY**SIGN UP NOW***.) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Company info

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