Ardena is a reputed contract partner providing drug development, manufacturing, regulatory support and dossier writing, logistics and bioanalytical services to pharmaceutical customers globally. We guide our customers through the challenges of drug development to bring to the market life saving (or life bettering) new medicines fast. Our integrated service offering is designed to streamline the drug’s progress to clinic and beyond, a seamless flow of CMC information ensures fastest timeline and the best, phase appropriate, quality. We are team of over 400 professionals divided over 7 sites in Belgium, The Netherlands, Sweden, Latvia and Spain.
At Ardena we’re reliable, proactive, flexible and we want to be best in class!
Ardena Pamplona / Idifarma is a contract development and manufacturing organization (CDMO) located in Pamplona in center of the Spanish northern area, close to the French border, with nearby Airports in Pamplona, Biarritz and Bilbao. Ardena Pamplona is part of Ardena Drug Product Unit and is responsible for formulation and analytical development, manufacture and quality control of drug products. We are currently + 110 employees in our site.
We are looking for a Quality Assurance Director to join our team in Ardena Pamplona
YOUR KEY RESPONSIBILITIES
The Quality Assurance group plays a pivotal role in ensuring that all our development and manufacturing processes in our facility are executed according to GMP guidelines.
The Director of Quality Assurance is part of the local management team and is responsible for day-to-day implementation of the Quality System in our organization and is heading the QA department.
- Collaborate with stakeholders to set GMP QA strategy, and provide a development phase appropriate day to day GMP QA support to the operational teams.
- Provide leadership in ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of company operations
- Ensure the Company is kept current with all new quality-related regulatory requirements
- Implement improvement and maintain the quality management system.
- Direct all inspection readiness activities and manage customer or official audits.
- Direct the qualification, auditing, and ensure QA compliance with the company’s suppliers.
- Develop, track, and trend the Quality Metrics for CDMO performance.
- Establish Quality Agreements with customers.
- Promote a performance and improvement culture.
- Ideally, able to certify, confirm and release batches.
YOUR PROFILE LOOKS LIKE/ RESEMBLES
- You have a MSc or PhD degree in biomedical or life sciences (e.g. Pharmacy, (Bio)Chemistry or Biology).
- In depth experience with Quality Systems and Quality Management programs.
- Sound knowledge of a GMP quality system and its regulatory requirements.
- In depth knowledge of EU & FDA guidelines and regulatory agencies expectations.
- Minimum of 7 years of QA experience in a CDMO or biotech/pharma company.
- You are solution driven, keeping timelines and budget in mind.
- You are continuously looking for improvement.
- You have strong communication skills, able to listen and analyse a quality issue and explaining the proposed solution in an accurate manner.
- You are flexible, a problem solver and a team player.
- You have an analytical mindset and you are comfortable in stressful situations.
- You are quality and result orientated.
- You have good communication skills and are fluent in English.
- You have good coaching skills.
- We love creative thinking and pro-activeness.
- Fluent in Spanish
- Fluent in English
- Have 2+ years pharmaceutical in a similar position in the pharmaceutical industry
- Eligible for acting as qualified person in the European Union.
WHAT WE OFFER
- Opportunity to make impact on multiple projects with a variety in formulations and technologies
- Ability to further grow your technical and managerial skills while working within multidisciplinary teams
- A true learning environment where you will have the ability to grow your skills
- A rapidly International developing and growing company with an interesting services and customer portfolio
- A dynamic working environment with nice colleagues
- Open straightforward but also caring culture
- We are true to our values
If this role resonates with you and you are eager to start your Ardena journey, we are looking forward to your application.
Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update.
Agency calls will not be appreciated.