Head of Quality Assurance
Location: GermanySIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices and Pharmaceutical organization, based in Baden-Württemberg Germany.
My client, an international organization in the Life Sciences industry, is currently looking for a Head of Quality Assurance to lead the department within their Pharmaceutical and Medical Device branches. The position is located in the Southwest of Baden-Württemberg and to be filled immediately on a permanent base.
ROLE DESCRIPTION
In the role as Head of QA you act as the Quality Management Representative according to ISO 13485 and GMP Officer according to EU-GMP-guideline within our Medical and Regulatory Affairs Department. In your function as GMP Officer you ensure that the pharmaceutical products are manufactured, tested, released and stored in compliance with the Good Manufacturing Practices (GMP). The job holder is also responsible for the control and release of medical devices.
RESPONSIBILITIES
Responsibility for ensuring that a QMS is established, implemented, maintained, reviewed and continually improved in accordance with all necessary GxP, Quality regulations and standards
Responsibility over maintaining the QMS Management Reviews
Ensuring the implementation and enforcement of QMS for the affiliate and GxP suppliers.
Ensuring the creation, maintenance and implementation
Preparing and conducting Quality System audits
Investigation of quality issues as well as identification and documentation CAPAs
Ensuring GxP supplier management as well as the management of deviations and Change Control
Ensuring that the Annual Quality Risk Assessment is performed properly and on time
Acting as the Head of the internal auditors. Therefore ensuring an appropriate education of the internal auditors
REQUIREMENTS
Graduated pharmacist or scientist (PhD or PharmD degree)
10 years of relevant work experience with responsibilities in GMP/QA
Significant experience in a Quality role in a regulated industry (Devices or Drugs) with GxP experience and knowledge of supplier Quality management and Quality auditing
Excellent knowledge of drug and medical device regulations, GMP and ISO Standards (GMP, GxP, ISO 134851, ISO 14791 and MDD)
Several years experience of leading people of cross-functional and project management teams
Excellent language experience of English and German
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.
