Sr. QA Manager - Irvine, CA | Biospace
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Sr. QA Manager

Apex Life Sciences

Irvine, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, Pharmaceutical, QA, Quality, Quality Assurance, Regulatory,

Job Description

Pharmaceutical & Biotechnology Contract Manufacturing Organization is seeking a QA Manager to join their team!


Manage Quality department to produce results in terms of product quality and product release
Implements the quality systems procedures in several sections or dept. and manages compliance
Understands and assures conformance to regulations applicable to the department and interfaces with regulators during various inspections
Manages quality assessments of internal operations and suppliers to analyze compliance and assess risk
Interacts frequently with employees, functional peer and senior group managers
Manages interactions with regulations and customer by representing the company products and processes
Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
Manages coaching, training, evaluations of subordinates from the department
Completes on-site supplier audits, desktop audits and interacts with suppliers. customers to resolve non-conformances and drive continuous improvement
Ensures implementation and compliance to EMA/ISO/CFR regulations
Leads the QA team to successfully accomplish clients’ project
Acts decisively on own authority when timely action is needed
Meets client expectation by applying sound QA management practices
Develop and manage creation and execution of test plans
Sets QA team members expectations by ensuring project team members understand the linkage of their own wok to the success of the project
Identifies, manages and communicates risks
Assures QA related documentation is maintained throughout project
Creates an overview of all products, applications, identifies testing requirement, performs risk assessment and establishes continuous monitoring program to assure product quality throughout the product life cycle.
Defines and executes necessary steps to improve quality.
Provides input on quality assurance, regulatory as well as general strategic issues
Schedules Quality Assurance employees in accordance to testing needs and all projects
Other duties as assigned by direct Supervisor



BS Degree in Science or Engineering
10 plus years’ experience in quality, manufacturing and pharmaceutical environment