QA – Quality Assurance Sr. Manager
23 hours ago
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 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: Applications will be reviewed on a rolling basis.
We look forward to hearing from you
CompanySymphogen 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.
#J-18808-Ljbffr-
Senior Manager Quality Assurance
2 weeks ago
Ballerup, Ballerup Kommune, Denmark Symphogen Full timeJob SummaryA challenging opportunity has arisen for a Senior Manager Quality Assurance to join our international biotech development activities at Symphogen. This role will involve leading the quality assurance team, ensuring compliance with GMP regulations and developing processes to support the quality system.About the CompanySymphogen is a subsidiary of...
-
Senior IT Quality Assurance Expert
2 months ago
Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full timeAbout the JobWe are seeking a highly skilled Senior IT Quality Assurance Expert to join our team in Ballerup, Denmark. This is an exciting opportunity to work with us and contribute to the development of our IT quality management globally.As a Senior IT Quality Assurance Expert, you will be responsible for providing IT QA subject matter expertise in the GMP...
-
Senior IT Quality Assurance Specialist
3 weeks ago
Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full timeAbout Novo Nordisk A/SAt Novo Nordisk, we drive change and strive for excellence. We're a dynamic company in the pharmaceutical industry, dedicated to moving the needle on patient care.A career with purposeWe're not just looking for talented employees; we want individuals who share our commitment to innovation and quality. As an Senior IT Quality Assurance...
-
Quality Assurance Specialist
2 weeks ago
Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full timeCompany Overview:We are a leading gaming technology company, dedicated to delivering innovative products and software solutions that enhance the gaming experience.Salary:The estimated salary for this position is $80,000 - $110,000 per year, depending on experience and qualifications.Job Description:We are seeking a highly skilled Quality Assurance (QA)...
-
Senior Quality Assurance Manager
4 weeks ago
Ballerup, Ballerup Kommune, Denmark Symphogen Full timeAbout the RoleWe are seeking a highly skilled Senior Quality Assurance Manager to join our team at Symphogen, a subsidiary of Servier and antibody center of excellence primarily focused on oncology and immune oncology.Job SummaryThe successful candidate will be responsible for further developing and maintaining the Quality System, including international...
-
Dynamics ERP Quality Assurance Strategist
2 weeks ago
Ballerup, Ballerup Kommune, Denmark Columbus AS Full timeDrive Digital Transformation in the Danish Market">Columbus A/S is a global IT consulting company that empowers businesses to thrive in the digital age. As our new D365 Sr. Test Manager, you will play a pivotal role in shaping the future of Quality Assurance and Testing services for Dynamics ERP implementations in Denmark.">Your primary responsibility will...
-
Quality Assurance Engineering Leader
6 days ago
Ballerup, Ballerup Kommune, Denmark Ambu AS Full timeAbout the RoleWe are seeking an experienced Senior Quality Assurance Engineer to join our Global Quality Management Operations team at Ambu A/S in Denmark.Job DescriptionThis role is responsible for driving Post Market Surveillance with business partners, ensuring compliance with regulatory requirements, and facilitating timely performance of PMS plans and...
-
Ballerup, Ballerup Kommune, Denmark DISCREADIS - Dansk IngeniørService AS Full timeWe are seeking a highly skilled Quality Assurance Expert to join our team at DIS. In this role, you will have the opportunity to work on a wide range of projects within the life science industry.As a Quality Assurance Expert, you will be responsible for providing solutions for customers in multiple industries. You will work independently to oversee...
-
Quality Assurance Specialist
1 month ago
Ballerup, Ballerup Kommune, Denmark DISCREADIS - Dansk IngeniørService AS Full timeDIS is experiencing significant growth and seeking additional colleagues to focus on QA and validation tasks for various life science customers.Your Key ResponsibilitiesAs a Quality Assurance Specialist, you will work as a consultant either on-site with the customer or from a DIS office. Your primary tasks involve providing solutions for a diverse customer...
-
IT Quality Expert
6 days ago
Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled IT Quality Professional to join our team at Novo Nordisk A/S.Job Description:The primary role involves providing IT QA subject matter expertise in the GMP domain, focusing on key quality activities and deliverables. Activities will range from advising on risk management, quality planning, and approving...
-
Ballerup, Ballerup Kommune, Denmark DISCREADIS - Dansk IngeniørService AS Full timeWe are a leading consultancy firm DIS/CREADIS - Dansk IngeniørService A/S, seeking a highly skilled QA and validation professional to join our team in Ballerup. Our company is experiencing significant growth and expansion in the life science industry.Compensation: The estimated salary for this position is approximately 550-650 EUR per hour or 80,000-110,000...
-
IT Quality Expert with Global Impact
1 month ago
Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking an experienced IT Quality Professional to join our team at Novo Nordisk A/S in Ballerup, Denmark.Job DescriptionThis exciting opportunity involves providing IT QA subject matter expertise in the GMP domain to projects, systems, and services. Your primary role will involve advising on risk management, quality planning, approving...
-
Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full timeJob DescriptionWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Novo Nordisk A/S. As a key member of our ET QA New Entry & Support department, you will play a vital role in ensuring the quality and compliance of our products.The ideal candidate will have a strong background in quality assurance, with experience in QC...
-
Senior Quality Assurance Engineer
5 days ago
Ballerup, Denmark Ambu AS Full timeDepartment: Global Quality Management Operations & IT Compliance Employment Type: Full-time Senior Quality Assurance Engineer Are you excited by quality and compliance within the Medical Device industry? Do you want to be a part of a global organization with high professional standards and a great working environment? Then we have an exciting job...
-
Chief Software Quality Assurance Manager
3 weeks ago
Ballerup, Ballerup Kommune, Denmark KMD AS Full timeKMD A/S, Denmark's largest IT company, offers a challenging opportunity for a Chief Software Quality Assurance Manager to join our Application Development & Modernization department. The role involves advising and assisting clients with their software development challenges.About the Job:As a Senior Test Manager at KMD A/S, you will be part of our...
-
Ballerup, Ballerup Kommune, Denmark DISCREADIS - Dansk IngeniørService AS Full timeCompany OverviewWe are a leading consultancy firm, DIS/CREADIS - Dansk IngeniørService A/S, experiencing significant growth in the life science industry. We are seeking highly skilled professionals to join our team as Quality Assurance Specialists.Estimated SalaryThe estimated salary for this position is between 80,000 - 110,000 DKK per year, depending on...
-
Ballerup, Ballerup Kommune, Denmark KMD AS Full timeAbout the RoleWe are seeking an experienced Software Development Quality Assurance Manager to join our Application Development & Modernization department. This is a unique opportunity to advise and assist clients with their challenges, from small advisory and pilot projects to large, long-term modernization and development projects.Responsibilities:Active...
-
Advanced IT Quality Professional
4 months ago
Ballerup, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Ballerup, Denmark Jobkategori Quality Ansøg nu Are you passionate about collaborating with a team of highly skilled IT Quality Assurance professionals in a pharmaceutical IT environment? Do you aspire to achieve the highest quality in IT and stay at the forefront of new digital technologies, supporting the central Novo Nordisk...
-
QA and Validation Engineer – Ballerup
2 days ago
Ballerup, Denmark DISCREADIS - Dansk IngeniørService AS Full timeWe are experiencing significant growth and are seeking additional colleagues to focus on QA and validation tasks for a wide range of customers within the life science industry. Together with skilled colleagues, you will take part in the exciting journey! Your Role in Future Projects As an employee at DIS, you will become part of an ambitious environment with...
-
Ballerup, Ballerup Kommune, Denmark Ambu AS Full timeAbout the RoleWe are seeking a highly skilled and experienced Global Quality Assurance Leader to join our team at Ambu A/S. In this role, you will be responsible for leading global R&D project activities, taking ownership of risk management, and ensuring compliance with relevant regulations.Key ResponsibilitiesDrive global R&D project activities as QM lead,...
