Quality Assurance External Manufacturing

QA Ext. Manufacturing Specialist

Quality Assurance External Manufacturing
Would you like to work in one of the most interesting, complex, and dynamic areas in Bavarian Nordic? Are you ready to engage, support, and mobilize colleagues in a growing international business environment where we focus on saving lives every day? Then you could be our new colleague in the QA External Manufacturing department at Kvistgaard.

The position of QA Ext. Manufacturing
As a QA you will be responsible for daily support, QA oversight, and GMP guidance to Contract Manufacturing Organizations (CMOs) to ensure that our products are manufactured according to current GMP and our marketing authorizations.

You will solve a wide variety of tasks and have a great opportunity to be challenged every day. The main responsibilities of the QA Ext. Manufacturing Specialist are:

• Quality oversight of production and activities at the CMO with primary stakeholders
• Maintain and develop specialized knowledge within the field of responsibility
• Ensure timely review and QA-approval of CMO documents i.e. Change Controls, Deviations, PPQs, and any other project documents
• QA-responsible person for technical transfer projects
• Participate in process improvement activities across BN and CMOs

Qualifications
To succeed in this position the following experience and qualifications are required:

• You hold a degree as B.Sc. or M.Sc. degree in pharmacy, chemistry, engineering, or similar
• Minimum +3 years of experience in a pharmaceutical organization
• Up-to-date knowledge of GxP requirements i.e. Non-Conformity (NC), Corrective- and Preventive Actions (CAPA), Change Control, Annual Product Review (APR), Validations
• Knowledge of Drug Substance and Drug Product production is an advantage
• Knowledge of CMO handling, technical transfer, and PPQs is an advantage
• Great sense of accountability and ability to work independently and in teams
• Ability to handle tasks with a high level of complexity
• You have excellent communication skills and a collaborative mindset
• You have a pragmatic approach to problem-solving and strong interpersonal skills
• You are expected to be fluent in English

Personal skills
On a personal level, you are:

• Open-minded with a good sense of humor and an outgoing and confident attitude
• You enjoy a fast-paced and changing environment
• You must be willing and open to make decisions and be able to stand firm towards stakeholders at all levels when required to ensure compliance, while at the same time being able to build good and personal relationships
• You thrive by planning and setting an honor in implementing and performing tasks according to the plan
• You possess adaptability, a quick learning capacity, and the skill to thrive in unfamiliar settings
• You are detail-oriented and a strong ambassador of a quality mindset, but also able to apply pragmatic approaches and see things from a different angle when needed

Bavarian Nordic offers you personal and professional development and training.

About the department
We are expanding the QA Ext. Manufacturing Department which is responsible for quality assurance for outsourced production activities worldwide.

QA Ext. Manufacturing Department is a dynamic department characterized by a high level of professionalism, flexibility, and cooperation. The primary role of our department is to deliver QA support and set direction for our Global Contract Manufactures.

Since our CMOs are located worldwide, you are expected to travel 15+ days a year.

Your primary location will be in our manufacturing site in Kvistgaard, Denmark. It is important that you can be flexible and work remotely as well as being able to function in a team both virtual and in an office setting.

You will refer to the Director, QA Ext. Manufacturing, Effat Zaboli.

Our employees also have the advantage of being able to use our bus route, 70E, which runs from Humlebæk Station directly to our production facilities in Kvistgaard. The bus has four departures every morning and afternoon with scheduled stops at Hørsholmvej and Kvistgaard St.

The new service improves the commuting experience to and from Kvistgaard, where some of our employees can now benefit from a significant time savings of almost 40 minutes each way, making their daily commute more efficient and convenient.

Department: Philip Heyman's Allé 3, Hellerup

Lokation: Denmark