Senior Manager, Quality Assurance and Compliance
3 weeks ago
The Role
We are looking for a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP. You are likely already an experienced lead auditor with the capabilities to train other auditors within GCP/GCLP. You are familiar with internal process audits and CRO audits of clinical data processing in different IT systems. You have a deep knowledge of the requirements related to computerized systems in clinical trials and you understand the impact.
As QA Senior Manager you will have in-depth and strong scientific expertise within quality assurance and all regulatory requirements related to clinical development. You will have strong analytical skills, high quality standards, and attention to detail as well as the ability to apply these qualities into a strategic context that enables you to identify solutions within agreed deadlines.
You will be working in a global team with QA colleagues located in the US, the Netherlands, Japan and Denmark. Furthermore, you will be part of a strong cross-functional collaboration throughout the company.
Key responsibilities include:
- You will plan, conduct, report and follow up on quality audits within the GCP regulated areas.
- Mentor on-boarding QA colleagues as well as experienced Lead auditors to increase the competency level across the global QA GCP & PV team.
- You will develop and maintain the audit strategies in collaboration with the Team Lead
- You will coordinate and lead GCP inspection readiness activities for FDA, EMA and PMDA inspections.
- You will participate in inspections and audits performed by our partners.
- Participate in, or drive the development, maintenance, and improvement of the Genmab QMS with focus on GCP and GCLP requirements.
- Conduct and coordinate internal GCP training.
- Deliver GCP advisory expertise both within the company and to external vendors.
Requirements:
- MSc in Natural Science or similar and at least 5 years of profound experience within GCP and GCLP.
- Experienced Lead Auditor within GCP and/or GCLP, preferably with in-depth knowledge related to internal process audits and CRO audits of clinical data processing in different IT systems.
- Practical proficiency in the use and understanding of Veeva Vault QMS.
- Experience with the due diligence process and qualification of new vendors or services.
- Considered to be a Domain Expert within GCP and/or GCLP by peers with a strong interest and ability to educate others.
Moreover, you meet the following personal requirements:
- Strong analytical skills with an eye for detail combined with the ability to extract and apply into a tactical and strategic context.
- To strive and thrive in a setting with multiple complex tasks and shifting priorities.
- Pro-active and open-minded, a dedicated team player with excellent oral and written communication skills
This role can be located in Copenhagen, Denmark, or Utrecht, the Netherlands, or Princeton, New Jersey, U.S.
The role is hybrid, with an expectation of 60% on-site presence, combined with the option to work remotely two days per week on average.
About You
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
-
Senior Quality Assurance Manager
2 weeks ago
Copenhagen, Copenhagen, Denmark Getinge Full timeSenior Quality Assurance ManagerGetinge is seeking a highly skilled Senior Quality Assurance Manager to lead the development, implementation, and maintenance of quality management systems in line with Getinge requirements and industry standards.The ideal candidate will have a strong understanding of regulatory frameworks, proficiency in developing SOPs,...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeJob DescriptionWe are seeking a highly motivated Senior Manager to join our Quality Assurance team in Copenhagen, Denmark. As a Senior Manager, you will be responsible for leading quality audits within the Good Clinical Practice (GCP) regulated areas, mentoring QA colleagues, developing audit strategies, and coordinating GCP inspection readiness...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAre you passionate about ensuring the highest quality standards for life-saving products?Lundbeck is seeking a seasoned Senior Quality Assurance Specialist to join our team in Valby.In this role, you will be responsible for supporting the standardization of CMOs globally and driving product and process improvements in an international environment.You will...
-
Senior Quality Assurance Professional
1 week ago
Copenhagen, Copenhagen, Denmark UNICEF Full timeRole OverviewWe are seeking a highly skilled Senior Quality Assurance Professional to join our team at UNICEF in Copenhagen. As a key member of our Quality Assurance Centre, you will play a critical role in ensuring the highest standards of quality management systems and regulatory compliance.Key ResponsibilitiesLead Non-Pharma Inspection Unit: Oversee the...
-
Senior Quality Assurance Manager
3 weeks ago
Copenhagen, Copenhagen, Denmark Cognizant Full timeAbout UsCognizant is a leading provider of digital transformation solutions. We help our clients modernize technology, reimagine processes, and transform experiences. As a global thought leader in QA, we bring first-time-right quality and proven next-generation QE solutions to our clients' most important initiatives.About the RoleWe are seeking a Senior...
-
Senior Quality Assurance Specialist
4 days ago
Copenhagen, Copenhagen, Denmark airbus Full timeAbout the RoleWe are seeking an experienced Senior Quality Assurance Specialist to join our team in Copenhagen. In this role, you will play a key part in ensuring the quality and compliance of our products.Job ResponsibilitiesYou will work closely with our Quality Management team to ensure that all products meet the required standards.Performing inspections...
-
Copenhagen, Copenhagen, Denmark Aj Vaccines AS Full timeLead Process Improvement and Quality Assurance at Aj Vaccines A/SWe are seeking a Senior Quality Assurance Process Improvement Specialist to join our team at Aj Vaccines A/S. As a key member of our Quality Assurance department, you will be responsible for driving process improvements and leading the implementation of LEAN methodologies.Key...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly experienced Senior Quality Assurance Director to lead our Pharmacovigilance team. As a key member of our quality assurance department, you will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in all aspects of PV activities.
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeJob DescriptionWe are seeking a highly skilled Senior Pharmaceutical Quality Assurance Specialist to join our team at Lundbeck. In this role, you will play a key part in ensuring the quality of our products and processes, working collaboratively with our CMO partners.About the RoleAs a Senior Pharmaceutical Quality Assurance Specialist, you will be...
-
Senior Quality Assurance Lead
16 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab is a global biotech leader in the development of antibody products and pioneering therapies. We are committed to safeguarding patients and ensuring quality compliance in all aspects within Pharmacovigilance.About the Role:We are seeking a highly motivated Senior Quality Assurance Lead with at least 6 years of experience in auditing PV activities. As...
-
Senior Scientist, Quality Assurance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark AGC Inc Full timeAbout the RoleAs a Senior Scientist in Quality Assurance for Quality Control, you will play a key role in ensuring the highest standards of quality in our manufacturing processes.Located in Copenhagen, Denmark, this position requires a deep understanding of Quality Assurance principles and regulations to support the development and commercialization of...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleWe are seeking a highly motivated and experienced Quality Assurance Manager to join our clinical development team at Genmab. As a Quality Assurance Manager, you will play a crucial role in ensuring the quality of our clinical trials and maintaining compliance with regulatory requirements.The ideal candidate will have at least 5 years of experience...
-
Senior Quality Assurance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark The Tailored Closet and PremierGarage of Nashville Full timeWe are looking for a highly skilled Senior Quality Assurance Specialist to join our team at The Tailored Closet and PremierGarage of Nashville. In this role, you will be responsible for ensuring the quality of our software products and providing valuable inputs to improve product quality. You will work closely with the QA - Automation & Manual Test...
-
Senior Quality Assurance Director
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob DescriptionGenmab is seeking a highly experienced Quality Assurance (QA) professional to join our Late Stage Development team in Denmark. As a Senior Quality Assurance Director, you will be responsible for setting the quality direction for Genmab's Late Stage Development products and ensuring compliance to industry standards and regulations.Key...
-
Quality Assurance Specialist
1 month ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeJob Title: Quality Assurance ProfessionalWe are seeking an experienced Quality Assurance Professional to join our team at Lundbeck. As a key member of our Corporate Product Quality Systems department, you will play a crucial role in ensuring the quality and compliance of our products.About the RoleAs a Quality Assurance Professional, you will be responsible...
-
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeJob DescriptionWe are seeking a highly skilled Quality Assurance Professional to join our team at Lundbeck A/S, H in Copenhagen. This exciting role offers the opportunity to apply your strong quality mindset and contribute to strengthening our commercial manufacturing and distribution processes.Key ResponsibilitiesDeveloping and facilitating global and local...
-
Quality Assurance Process Improvement Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark AJ Vaccines Full timeWe are seeking a highly skilled Quality Assurance Process Improvement Specialist to join our team at AJ Vaccines. In this role, you will have the opportunity to shape and develop a new position within our Quality Assurance department, working closely with senior leadership to drive process improvements and implement LEAN methodologies.Key...
-
Senior Quality Assurance Manager
3 weeks ago
Copenhagen, Copenhagen, Denmark Cognizant Full timeAbout the RoleCognizant is seeking a Senior Test Manager to join our QE&A Practice Team. As a Senior Test Manager, you will lead our QE&A, which specializes in test management of large complex and often digital transformation programs at clients. We use a variety of testing Automation tools and frameworks to increase the automation adoption, making sure that...
-
Quality Assurance Leader
4 days ago
Copenhagen, Copenhagen, Denmark National Oilwell Varco Denmark IS Full timeAbout the RoleWe are seeking an experienced Quality Assurance Leader to join our Subsea Production Systems team in Copenhagen. As a key member of our senior leadership team, you will be responsible for developing and implementing a global quality assurance vision that aligns with our objectives and values.Key ResponsibilitiesStrategic Leadership: Develop and...
-
Quality Assurance Process Improvement Specialist
1 month ago
Copenhagen, Copenhagen, Denmark Aj Vaccines AS Full timeTransform Quality Assurance at Aj Vaccines A/SWe are seeking a visionary Quality Assurance Lean Partner to spearhead the development of a new role within our Quality Assurance department. As a key member of our team, you will have the opportunity to shape and define this role from the ground up, working closely with senior leadership to drive strategic...
