GMP QA Manager
3 weeks ago
About the Role
We are seeking a highly skilled GMP QA Manager to join our team at Genmab. As a GMP QA Manager, you will be responsible for ensuring the quality of our commercial products, including starting materials, intermediates, and drug substances. You will work closely with our Contract Manufacturing Organizations (CMOs)/Partners and process- and QC SMEs internally at Genmab.
Key Responsibilities
- Maintaining and continuously improving Genmab's Pharmaceutical Quality System to ensure compliance with EU and US regulations.
- Gaining and maintaining knowledge on new/updated GMP/GDP-regulations and guidelines.
- Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements.
- Act as Delegated QP for the release of commercial products (Biological Intermediates, Chemical Intermediates and Drug Substance).
- Reviewing and authoring of QMS SOPs, Work Instructions and other documents, as needed.
- Supporting Quality Management Review and Annual Product Review.
- Performing QA activities in relation to US market release in close cooperation with the global QA GMP team, Genmab's CMOs, contract acceptors and Partners.
- Providing QA oversight of contractors/vendors in relation to outsourced GMP/GDP activities including Audits, Vendor Risk Evaluations, and review and negotiation of Quality Agreements.
- Representing QA GMP in project groups to advise on GMP compliance.
- Participating in internal audits and regulatory inspections performed by various Health Authorities.
- Train QA colleagues and stakeholders in relevant GMP topics.
- Promote collaborative relations with relevant internal stakeholders, partners and CMOs.
About You
- You hold a Master's degree or equivalent in a relevant life science subject.
- You have 5+ years experience within the pharmaceutical industry within QA.
- Experience with biological and chemical GMP production.
- Experience with CMO collaboration.
- Experience with audits/inspections.
- QP/delegated QP experience.
What We Offer
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. We offer a dynamic and collaborative work environment, with opportunities for professional growth and development. If you are passionate about quality and committed to excellence, we encourage you to apply for this exciting opportunity.
-
GMP QA Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled GMP QA Manager to join our team at Genmab. As a GMP QA Manager, you will be responsible for ensuring the quality of our pharmaceutical products and processes. This includes maintaining and improving our Pharmaceutical Quality System, handling deviations and CAPAs, and reviewing and authorizing QMS SOPs and other...
-
Senior Biotechnology QA Manager
4 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleAt Genmab, we are seeking a highly skilled and experienced Senior Biotechnology QA Manager to join our team in Copenhagen. This is an excellent opportunity for a results-driven professional to take on a challenging role and contribute to the success of our organization.This position will report directly to the Director of QA GMP Commercial &...
-
GMP/GDP Auditor, CMC Development QA Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeGMP/GDP Auditor, CMC Development QA RoleThis is an exciting opportunity for an international position as a GMP/GDP auditor in CMC Development QA, supporting the development of new innovative treatments for brain diseases. As a lead auditor, you will have an important role conducting external audits of CMC vendors as well as internal audits of CMC. We offer a...
-
GMP/GDP Auditor, CMC Development QA Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeGMP/GDP Auditor Role OverviewThis is a great opportunity for an international position as GMP/GDP auditor in CMC Development QA, supporting the development of new innovative treatments for brain diseases. You will have an important role as lead auditor conducting external audits of CMC vendors as well as internal audits of CMC. We offer an exciting job,...
-
GMP/GDP Auditor, CMC Development QA Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeGMP/GDP Auditor, CMC Development QA SpecialistThis is an exciting opportunity to join our team as a GMP/GDP auditor in CMC Development QA, supporting the development of new innovative treatments for brain diseases. You will have a key role as lead auditor conducting external audits of CMC vendors as well as internal audits of CMC. We offer a challenging job,...
-
GMP/GDP Auditor, CMC Development QA Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeGMP/GDP Auditor, CMC Development QA RoleThis is a great opportunity for an international position as GMP/GDP auditor in CMC Development QA, supporting the development of new innovative treatments for brain diseases. You will have an important role as lead auditor conducting external audits of CMC vendors as well as internal audits of CMC. We offer an...
-
GMP/GDP Auditor for CMC Development QA
2 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeRole SummaryLundbeck seeks a highly skilled GMP/GDP Auditor to join its CMC Development QA team. As a key member of this team, you will play a vital role in ensuring the quality and compliance of our CMC vendors.Key ResponsibilitiesConduct external audits of CMC vendors to ensure compliance with GMP/GDP regulationsLead internal audits of CMC to identify...
-
GMP/GDP Auditor, CMC Development QA Specialist
1 month ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleWe are seeking a highly skilled GMP/GDP Auditor to join our CMC Development QA team. As a key member of our team, you will be responsible for conducting external audits of CMC vendors and internal audits of CMC, ensuring compliance with regulatory requirements.Key ResponsibilitiesConduct external audits of CMC vendors to ensure compliance with...
-
GMP/GDP Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeCareer Opportunity for GMP/GDP AuditorLundbeck is seeking a highly experienced GMP/GDP auditor to join our CMC Development QA team.About the RoleThe successful candidate will be responsible for conducting external audits of CMC vendors and internal audits of CMC. This is an exciting opportunity to work with a growing department supporting the development of...
-
GMP/GDP Auditor for CMC Development QA
3 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeExciting Opportunity in Quality AssuranceLundbeck is seeking a skilled GMP/GDP Auditor to join our CMC Development QA team. As an auditor, you will play a critical role in ensuring the quality of our pharmaceutical products.About the RoleAs a GMP/GDP Auditor, you will be responsible for conducting external audits of CMC vendors and internal audits of CMC....
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeThis role offers a unique opportunity to join Lundbeck's CMC Development QA team as a GMP/GDP Auditor.About the RoleAs a GMP/GDP Auditor, you will be responsible for conducting external audits of CMC vendors and internal audits of CMC. You will also contribute to the continuous improvement of the audit process.Key ResponsibilitiesConduct external audits of...
-
Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full timeJob Description:Ascendis Pharma invites you to explore the role of our newest QA Specialist / QA Professional for Development GMP activities. As a passionate Quality Assurance professional, you will play a pivotal role in ensuring the QA oversight of outsourced development activities carried out at our Contract Laboratories and Manufacturing...
-
QA Specialist for Facilities and Equipment
1 month ago
Copenhagen, Copenhagen, Denmark AJ Vaccines Full timeJoin a team that saves lives worldwide! Are you passionate about making a difference and ensuring the quality of life-saving products? We're looking for talented professionals to join our QA team. As a QA Senior Specialist, you'll play a crucial role in our mission to save lives globally.About the Team Our QA team consists of around 50 colleagues working in...
-
Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full timeJoin Our Team as a QA Specialist for Development GMP ActivitiesWe are seeking a highly skilled QA Specialist to join our team in Copenhagen, Denmark. As a vital contributor to our QA team, you will play a pivotal role in ensuring the quality oversight of our outsourced development activities.About the RoleAs a QA Specialist, you will be responsible for...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeGlobal Pharmaceutical Development OpportunityLundbeck, a leading pharmaceutical company, seeks an experienced QA Vendor Manager to join its CMC Development QA organization.About the RoleWe are looking for a highly skilled and motivated individual to oversee the vendor management program, ensuring compliance with GMP/GDP regulations and patient safety.Your...
-
Senior QA Specialist for CMC Development
2 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeSenior QA Specialist for CMC DevelopmentThis is a unique opportunity to lead the QA of the Lundbeck CMC vendor management program while contributing to the development of innovative treatments for brain diseases.We offer an exciting job with a broad variety in your daily work ensuring compliant vendor oversight of Lundbeck CMOs for clinical trials. CMC...
-
Senior Vendor Specialist, CMC Development QA
2 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeSenior Vendor Specialist, CMC Development QALundbeck is seeking a highly skilled Senior Vendor Specialist to lead the CMC vendor management program. As the QA lead, you will drive the continuous development of the program, including training of colleagues, and ensure compliant vendor oversight of Lundbeck CMOs for clinical trials.Key ResponsibilitiesQA owner...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeGMP/GDP Auditor, CMC Development and Quality Assurance Specialist This is an exciting opportunity for an international position as a GMP/GDP auditor in CMC Development and Quality Assurance, supporting the development of new innovative treatments for brain diseases. In this role, you will have a vital part as a lead auditor conducting external audits of...
-
GMP/GDP Auditor
3 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeGMP/GDP Auditor - CMC Development Quality Assurance At Lundbeck, we are seeking a skilled GMP/GDP Auditor to join our CMC Development QA team. As a key member of our team, you will be responsible for conducting external audits of CMC vendors and internal audits of CMC, ensuring compliance with regulatory requirements. Your role will involve...
-
QA Senior Specialist for Quality Control
1 month ago
Copenhagen, Copenhagen, Denmark AJ Vaccines Full timeRedd liv på verdensplan - søg stillingen som QA Senior SpecialistEr du passioneret om at sikre kvaliteten af livsvigtige produkter og bidrage til at redde liv på globalt plan? Så er denne stilling måske noget for dig.Om stillingenSom QA Senior Specialist i QA-afdelingen på AJ Vaccines vil du spille en afgørende rolle i vores mission. Du vil være...