Quality Assurance Manager - Pharmaceutical

TITLE – Quality Assurance Manager

JOB DESCRIPTION – Our client, a well-established Washington State manufacturer of biological products seeks a motivated Quality Assurance Manager to perform the following:

TASKS
· Implement the overall quality strategies as defined on the company level. Further
develop and execute local quality strategies for the company as found relevant to meet
the Customer Requirements
· Develop and maintain the quality system of the company to comply with cGMP, ICH
Q7A and all other regulations within the framework defined by the Group Quality
System adjusted to the operations of the company
· Ensure efficient management of all elements of the Quality System including
Personnel, Facilities, Documentation & Records, Materials Management and
Production including Collection/Farming activities, Laboratory controls, Packaging,
Storage & Distribution
· Ensure a well-run, efficient quality unit with motivated and adequately trained
personnel to meet current and future demands
· Ensure a professional QA support to the day-to-day operations as well as to the
activities related to current and future projects or the organization
· Maintain a system for monitoring regulatory requirements and -trends including QA
related issues within the industry
· Monitor the efficiency of the quality system by performing internal audits at regular
intervals
· Contribute actively to prevent and correct any quality issues through a close cross-
functional cooperation
· Release final product for sale and distribution
· Approve all specifications, procedures, protocols and reports
· Serve as company representative for FDA and other regulatory audits
· Contribute to defining quality goals and KPIs
· Report to executive management regarding quality performance, and the progress of
meeting defined goals and KPIs and include this information in the monthly Global QA
report to QA Management
· Represent the company at bi-annual Global Quality meetings.

BACKGROUND
· Masters degree in a scientific discipline related to Pharmaceutical Quality Assurance
and Quality Management Systems e.g. Industrial Pharmacy, Pharmaceutics,
Pharmaceutical Regulatory and Quality Compliance, Biomedical Quality Systems,
Pharmaceutical Science
· 5-10 years experience in a pharmaceutical manufacturing company preferable handling
Biological Source Materials, and/or API’s
· At least 5 years experience as a Manager
· Solid knowledge of relevant Regulatory requirements and procedures (US and EU); i.e.,
cGMP, ICH-Q7A, and other relevant regulations and guidances
· Knowledge of scientific mathematics and a clear understanding of statistical concepts
including solid experience in the use of e.g. productivity and statistical software
· Good communication skills; oral and written
· High energy level, humor, motivated self starter, a natural authority and flair for being a manager
· Ability to work independently and systematically with a solid pragmatic approach
· Ability to travel internationally
· Ability to work with allergenic materials

WE OFFER
· A job in a global pharmaceutical company in a rapid development
· Exciting tasks and the possibility to have significant influence on development
· International travel
REQUIREMENTS
(See Job Description)