Current jobs related to Senior Quality Assurance Manager, GCP - Copenhagen, Copenhagen - Ascendis Pharma AS
-
Senior Quality Assurance Specialist, GCP
4 weeks ago
Copenhagen, Copenhagen, Denmark Ascendis Pharma Full timeJoin Our Team as a Senior Quality Assurance Specialist, GCPAscendis Pharma is a leading biopharmaceutical company with a strong focus on developing innovative therapies for patients with unmet medical needs. We are seeking a highly motivated and experienced Senior Quality Assurance Specialist, GCP to join our team in Hellerup, Denmark.As a Senior Quality...
-
Senior Manager, Quality Assurance GCP/PV
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleWe are seeking a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP to join our team at Genmab. As a QA Senior Manager, you will have in-depth scientific expertise within quality assurance and all regulatory requirements related to clinical development. You will be able to combine your strong project...
-
Global GCP Quality Assurance Expert
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe Genmab Team is seeking a highly experienced and skilled Global GCP Quality Assurance Expert to join our QA team. The role offers an exciting opportunity to utilize your expertise in quality assurance, regulatory compliance, and audit management to drive the company's growth and success.About the RoleAs a key member of our QA team, you will be responsible...
-
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...
-
Director of Quality Assurance GCP and PV
1 day ago
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab is seeking a highly motivated Director of Quality Assurance GCP and PV to join our global QA team. This role offers the opportunity to work in a fast-paced, dynamic environment with a talented team of professionals dedicated to delivering high-quality products.About the RoleThis position will lead the development and implementation of quality...
-
Senior Manager, Quality Assurance GCP/PV Leader
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeRole OverviewGenmab is seeking a highly motivated QA Senior Manager with a strong background in GCP and GCLP to safeguard patients and ensure quality compliance in all aspects within GCP.Key Responsibilities Represent QA GCP in the Clinical Development Process Expert Group (PEG) and in the Regulatory Registration PEG. Lead the SOP QA review process to...
-
Senior Manager, QA GCP/PV
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly motivated and experienced Quality Assurance Senior Manager to join our team at Genmab. As a key member of our Quality Assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our clinical development programs.Key ResponsibilitiesDevelop and implement quality audit strategies...
-
Senior Manager, Quality Assurance and Compliance
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleWe 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...
-
Senior Manager, QA GCP/PV
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleWe are seeking a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP to join our team at Genmab. As a QA Senior Manager, you will have in-depth scientific expertise within quality assurance and all regulatory requirements related to clinical development.Key Responsibilities:Plan, conduct, report, and follow...
-
Senior Manager, QA GCP/PV
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleWe are seeking a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP to join our team at Genmab. As a QA Senior Manager, you will have in-depth scientific expertise within quality assurance and all regulatory requirements related to clinical development.Key Responsibilities:Plan, conduct, report, and follow...
-
Senior Manager, QA GCP/PV
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleWe are seeking a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP to join our team at Genmab. As a QA Senior Manager, you will have in-depth scientific expertise within quality assurance and all regulatory requirements related to clinical development.Key Responsibilities:Plan, conduct, report, and follow...
-
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 Manager, QA GCP/PV
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly motivated QA Senior Manager to join our team at Genmab. This is an excellent opportunity to work in a dynamic and innovative company with a strong focus on quality assurance and regulatory compliance.Key ResponsibilitiesLead quality audits within the GCP regulated areas, ensuring compliance with regulatory...
-
Senior Manager, QA GCP/PV Lead
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob DescriptionThe RoleGenmab is seeking a skilled and experienced QA Senior Manager to join our team. As a key member of our Quality Assurance group, you will be responsible for ensuring the highest standards of quality and compliance in our clinical development programs.About the RoleYou will represent QA GCP in the Clinical Development Process Expert...
-
Senior Manager, QA GCP/PV
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly motivated and experienced Senior Manager to lead our Quality Assurance (QA) team in GCP and PV. As a key member of our global QA team, you will be responsible for planning, conducting, and reporting quality audits within the GCP regulated areas.Key ResponsibilitiesDevelop and maintain audit strategies in collaboration...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleThe RoleWe are seeking a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP to join our team at Genmab.This is a unique opportunity to work in a dynamic company with ambitious goals and exciting clinical development programs.As a QA Senior Manager, you will be responsible for ensuring clinical...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeUnlock a challenging opportunity to lead quality assurance efforts in clinical trials at Genmab, a pioneering biotech company dedicated to transforming the lives of patients with cancer and other serious diseases.We are seeking an experienced QA Senior Manager with a strong background in GCP and/or GCLP to join our global team. Your primary responsibility...
-
Senior Manager, QA GCP
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob Title: Senior QA Manager, GCP DivisionAbout the Role:We are seeking a highly motivated Senior QA Manager to join our GCP Division. As a Senior QA Manager, you will be responsible for ensuring the quality and compliance of our clinical trials. You will work closely with cross-functional teams to identify and address quality issues, develop and implement...
-
Senior Manager, Quality Assurance Regulatory
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe're looking for a highly motivated QA Senior Manager to join our team at Genmab, an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. As a QA Senior Manager, you will play a key role in ensuring the quality and compliance of our clinical trials and regulated areas.Key...
-
Senior Manager, QA GCP PV
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly motivated Quality Assurance Manager to join our team. As a key member of our QA team, you will be responsible for ensuring the highest level of quality and compliance in our clinical trials.Key ResponsibilitiesPlan, conduct, and report quality audits within the GCP regulated areas.Mentor and train QA colleagues and...
Senior Quality Assurance Manager, GCP
1 month ago
Ascendis Pharma A/S is a leading biopharmaceutical company with a strong focus on developing innovative therapies for patients with unmet medical needs. We are seeking a highly motivated and experienced Senior Quality Assurance Manager to join our GCP Quality team in Hellerup, Denmark.
Main Responsibilities:
- Collaborate with internal and external stakeholders to ensure the implementation and maintenance of GCP processes.
- Provide expert quality and compliance advice on GCP processes to clinical teams.
- Lead subject matter experts in the maintenance of current SOPs and the initiation and development of new procedures.
- Author and maintain SOPs owned by GCP Quality.
- Support regulatory intelligence monitoring, assess impact, and support the implementation of new/updated GCP requirements on current practices and processes with relevant functions.
- Participate in the planning, conduct, and follow-up on regulatory inspections.
- Collaborate with subject matter experts to formulate responses to audit/inspection findings relevant to GCP.
- Support quality development activities within the Quality Management System.
- Perform expert consultation on complex aspects of GCP to project teams and departments.
- Perform the role of quality partner to assigned departments and project teams.
- Monitor Quality systems to proactively identify risk.
- Support our Clinical trial supply team with IRT design and operation.
Requirements:
- Master's degree in a scientific discipline.
- Minimum of 5 years of relevant experience in the pharmaceutical industry with significant experience in GCP from clinical quality and compliance.
- Extensive experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs.
- Experience with computerized systems within GCP regulated areas and medical device experience would be an advantage.
- Proficient in English at a professional level, both written and spoken.
About Ascendis Pharma A/S:
Ascendis Pharma A/S is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States. We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
What We Offer:
- An exciting and challenging position in an entrepreneurial and international company with a short line of command.
- The opportunity to work with highly skilled and experienced colleagues to advance our exciting product pipeline.
- A competitive salary and benefits package.
- The chance to make a meaningful difference in patients' lives.
How to Apply:
Please submit your application in English, including your resume and a cover letter, to Louise Moe Engström, VP, GCP and GVP Quality. We look forward to hearing from you
