QA – Quality Assurance Sr. Manager

QA – Quality Assurance Sr. Manager The position as Quality Assurance Sr. Manager offers a unique QA possibility to be part of international biotechnology development activities within both the early and late-stage projects of antibodies including bi-specific and Antibody Drug Conjugates (ADC’s).
You will be part of the international Servier CMC quality organization where you will have influence on the shared quality system. You will be located at Symphogen, Ballerup, with close connection to the local biotech research and development environment and responsible for local quality.

As QA Sr. Manager with focus on the CMC (Chemistry, Manufacturing, and Controls) area you will secure and influence all the processes and steps in the Investigational Medicinal Product development. You will have a close collaboration with the CMC area managing process-and analytical development and validation, manufacture for clinical supply and the future market application processes.
Tasks and Responsibilities
The responsibilities include, but are not limited to:

• Further development and maintenance of the Quality System, including all international shared CMC procedures and the local Symphogen Quality Management System
• Maintenance of the Symphogen Electronic Document Management System, Veeva Vault
• Participate in project development work with GxP QA expertise providing GMP compliance
• Participate in evaluation and approval process including audits of our CDMO’s (Contract Development Manufacturing Organizations)
• Supervise GMP manufacturing of clinical trial material at our CDMO’s
• Deliver support to the documentation management and review from suppliers and CDMOs in order to ensure readiness for product release

The ideal candidate:

• A relevant academic degree in life science (MSc pharm or similar),and at least 5-10 years of experience working with QA and development.
• Up to date GMP knowledge, including the current FDA, EMA, and ICH guidelines within the pharmaceutical area
• Experience from the biopharmaceutical industry with IMP manufacturing for clinical trials
• QA management experience within project work in a multi-cultural environment
• Interest in building up and streamlining processes and systems to support the quality system
• Have interest in people management, as being the potential successor for the Symphogen QA Director
• Fluent in Danish and English, verbally and in writing (speaking French would be a positive ad on)
• Is a strong communicator, who is able to listen, while at the same time being pragmatic and flexible in the approach to problems and challenges
• Is honest and openminded with a good sense of humor
• Work independently as well as part of a team

We offer

• A challenging and versatile job in an international, innovative, flexible, focused and committed biotech environment
• Competitive salary based on qualifications, and flexible working hours
• Strong cross functional teamwork, room for individual performance and development, passionate, inspiring, and fun colleagues

Working in Symphogen
Being part of Symphogen, you will always have a challenging job in a creative, goal-oriented, and value-based environment with a meaningful mission – to advance superior mAb therapeutics to improve the lives of cancer patients. You will be a part of a highly engaged and inspiring organization with focus on diversity, teamwork, commitment – and on you as a person. You will be offered good development opportunities and a relevant benefit package.
For further information
For more information you are welcome to contact Beirholm Search, Hanne Beirholm, at +45 29440080. Please also see www.symphogen.com for information about our company.

If you are interested in the position, please mark your application and CV “QA Sr. Manager” and mail it to: [email protected]. Applications will be reviewed on a rolling basis.

We look forward to hearing from you!

Company
Symphogen is a subsidiary of Servier and antibody center of excellence primarily focused on oncology and immune oncology. We have a highly efficient antibody discovery and research platform supported by comprehensive early development capabilities.

Our antibody platform delivers antibodies with unique functionalities providing best or first in class potential as combination or mono therapy. Our approach and capabilities are well suited for combination therapies at the core of future cancer treatment.

Symphogen is located in Ballerup in the greater Copenhagen area. The company currently employs approximately 150 people

We aim to attract employees who can challenge status quo in the pursuit of excellence