Senior Manager Compliance Quality Assurance
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Senior Manager Compliance Quality Assurance
Xellia Pharmaceuticals
Join a leading global pharmaceutical company where your contributions will have a significant impact!
This role offers a unique opportunity to join Xellia Pharmaceuticals at an exciting time in their development and growth. In the role as Senior Manager in Compliance QA, you will be responsible for improving and maintaining the right level of quality in Xellia. You work across Xellia, where you collaborate with the production, QC, Regulatory Affairs, other Xellia sites and Sales & Marketing.
Together with your employees, you ensure that the quality systems work in the best possible way and are in accordance with current GMP rules. Xellia will continuously focus on your managerial development through a constructive dialogue with your immediate manager and the opportunity for both internal and external competency development.
Contribute to realising Xellia’s global growth strategy by leading optimization initiatives
You will be part of the Compliance Quality Assurance department. You will be leading a team of 9 colleagues who look forward to welcoming you. Together, you are responsible for Quality oversight and implementation of efficient quality systems at the factory in Copenhagen. You also work in a global organization and collaborate continuously with the sister factories around the world. The department support the day-to-day operations and projects to ensure the right level of compliance including authorization of quality documents.
Key main responsibilities
Some of your key responsibilities will be to:
- Develop the team of skilled QA specialists and be visible in the organization as the owner of CPH’s quality system
- Manage change controls and authorization of quality documentation such as qualifications, validations, SOPs, annual product review and complaints
- Conduct customer audits and authority inspections and ensure a structured follow-up afterwards
- Chair and facilitator of Quality management reviews
- Collaborate effectively with production departments in issues concerning compliance and quality via a strong compliance background and good people and negotiation skills.
Your background and professional experience
We imagine that you have extensive experience with GMP and associated quality systems – perhaps from a previous QA role. This is combined with some years of managerial experience. Your educational background can be as a pharmacist or an engineer. You can translate the GMP rules and facilitate their application in the daily execution, and you communicate clearly and distinctly in both Danish and English. It is an advantage if you have:
- Good knowledge of e.g. FDA / EU / ICH guidelines and application of these in quality systems
- Experience with continuous improvement of systems
- Experience of working with production departments.
Your personal qualifications:
- You can act as a proactive problem solver and respected advisor within the QMS area
- You are analytical, structured and pragmatic
- You have an engaging leadership style
- You are curious by nature and good at creating networks and relationships with colleagues and partners
Would you like to know more?
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group A/S. If you want to learn more about this position before submitting your application, please do not hesitate to contact Research Associate, Signe Bülow Hansen on tel.: +45 70 20 12 75. You can also apply via our website www.compasshrg.com and attach your CV, preferably as .pdf file. Please note that we will reply to the email address from which you send your CV.
About Xellia:
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals here.
Deadline for application: As soon as possible
Workplace: Copenhagen
Reference: 2205.066
Company: Xellia Pharmaceuticals
Information og data
Denne ledige stilling har jobtypen "Direktør", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Hele Danmark
Jobbet er oprettet på vores service den 15.2.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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