-
Senior Manager, QA GCP/PV
4 weeks ago
Genmab A/S Trenton, United StatesThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at · . · Senior Manager, QA GCP/PV (Clinical QMS) page is loaded · Senior Manager, QA GCP/PV (Clinical QMS) · Apply · ...
-
Senior Manager, QA GCP/PV
3 weeks ago
Genmab A/S Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Senior Manager, QA GCP/PV
1 week ago
Genmab A/S Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Senior Manager, QA GCP/PV
4 weeks ago
Genmab A/S Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Associate Director, QA GCP/PV
4 weeks ago
Genmab A/S Princeton, United StatesThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at · . · Associate Director, QA GCP/PV page is loaded · Associate Director, QA GCP/PV · Apply · locations · Copenhage ...
-
Associate Director, QA GCP/PV
2 weeks ago
Genmab A/S Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Manager, GCP Quality Assurance
4 weeks ago
Aquestive Therapeutics Trenton, United StatesJob Summary: · This position is responsible for providing robust quality oversight throughout Aquestive's development program. The successful candidate will provide quality expertise to manage and improve processes across Aquestive's development program, ensuring compliance with ...
-
Program Manager(GCP
1 week ago
TEPHRA Edison, United States: · Minimum of 12+ years of relevant experience is required. Out of this, four years of consulting experience is highly desirable. · • Experience in leading programs using Agile/SAFE/Scrum SDLC methodologies is highly desirable · • Professional certification (PMP or other progr ...
-
Manager, GCP Quality Assurance
2 weeks ago
Madrigal Pharmaceuticals Corporation Conshohocken, United StatesJob Description · Job DescriptionThis position will be responsible for GCP/Clinical Quality Assurance activities. The primary responsibilities will be to ensure to quality and compliance of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Ma ...
-
Manager, GCP Quality Assurance
4 weeks ago
Madrigalpharma Conshohocken, United StatesThis position will be responsible for GCP/Clinical Quality Assurance activities. The primary responsibilities will be to ensure to quality and compliance of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Madrigal SOPs, and current industry ...
-
Program Manager(GCP
1 week ago
TEPHRA Edison, United States: · Minimum of 12+ years of relevant experience is required. Out of this, four years of consulting experience is highly desirable. · Experience in leading programs using Agile/SAFE/Scrum SDLC methodologies is highly desirable · Professional certification (PMP or other program ...
-
CHC PV Data Strategy and Management Head
2 days ago
Sanofi EU Bridgewater, United StatesCHC PV Data Strategy and Management Head · Location: Bridgewater, NJ · Remote Work: Hybrid · Travel Expected: Minimal · Job Type: Full Time · About the Job · At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our indus ...
-
Manager, GCP Quality Assurance
3 weeks ago
Madrigal Pharmaceuticals Inc Conshohocken, United StatesThis position will be responsible for GCP/Clinical Quality Assurance activities. The primary responsibilities will be to ensure to quality and compliance of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Madrigal SOPs, and current industry ...
-
Manager, GCP Quality Assurance
4 weeks ago
Madrigal Pharmaceuticals Inc Conshohocken, United StatesThis position will be responsible for GCP/Clinical Quality Assurance activities. The primary responsibilities will be to ensure to quality and compliance of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Madrigal SOPs, and current industry ...
-
Manager, GCP Quality Assurance
2 weeks ago
Madrigal Pharmaceuticals Inc Conshohocken, United StatesThis position will be responsible for GCP/Clinical Quality Assurance activities. The primary responsibilities will be to ensure to quality and compliance of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Madrigal SOPs, and current industry ...
-
Global PV Case Management Specialist
3 weeks ago
Solomon Page Princeton, United StatesOur client, a leading pharmaceutical company, is looking for a Global PV Case Management Specialist in Princeton, NJ. This role is hybrid and will have a 1 year contract duration to start. · Responsibilities: · Support the oversight and management of the case processing activi ...
-
Clinical Trial Drug Safety Specialist
1 week ago
Everest Clinical Research Trenton, United StatesJob Category · : · Pharmacovigilance and Drug Safety · Requisition Number · : · CLINI001960 · Apply now · Posted : December 14, 2023 · Full-Time · Locations · Showing 1 location · Sofia, Bulgaria · Sofia, BGR · Description · Everest Clinical Research ("Everest") is a full- ...
-
GCP Bigdata Engineer
1 week ago
Net2source Trenton, United StatesJob Title: GCP Bigdata Engineer · Location: Phoenix (Day 1 onsite) · Hire Type: 6+ Month Contract (Extendable) · Looking for a Senior Software Engineer with strong analytical skills to help build and enhance our Big data application. · This individual's day-to-day work will i ...
-
Daiichi Sankyo Company, Limited Trenton, United StatesClinical Trial Manager, Global Oncology Medical Affairs page is loaded · Clinical Trial Manager, Global Oncology Medical Affairs · Apply · remote type · Hybrid Work Arrangement · locations · Basking Ridge, NJ · time type · Full time · posted on · Posted 3 Days Ago · jo ...
-
Vice President of Clinical Operations
4 weeks ago
i-Pharm Consulting Trenton, United StatesPosition Overview: As the Vice President of Clinical Operations, you will play a pivotal role in driving our client's clinical programs forward. You will be responsible for overseeing all aspects of clinical operations, from Phase I through Phase III trials. Your expertise in bui ...
Senior Manager, QA GCP/PV - Trenton, United States - Genmab A/S
Description
The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at.
Senior Manager, QA GCP/PV (Lead Auditor) page is loaded
Senior Manager, QA GCP/PV (Lead Auditor)
Apply
locations
Copenhagen
Utrecht
Princeton, NJ
time type
Full time
posted on
Posted 30+ Days Ago
job requisition id
R10145
At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role & DepartmentAre you inspired to work in a company with ambitious goals, exciting clinical development programs, and highly enthusiastic colleagues? Our vision by 2030 is that Genmab's knock-your-socks-off "KYSO" antibody medicines will transform the lives of people with cancer and other serious diseases.
Do you want to safeguard patients and ensure quality compliance in all aspects within GCP? – Then seize this great career opportunityWe 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 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.
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.
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 YouYou 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.
About GenmabGenmab 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.
For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies.
By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success.
No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.
Learn more about our commitments on our website .Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website
.
Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Similar Jobs (1)Senior Manager, QA GCP/PV (Clinical QMS)
locations
3 Locations
posted on
Posted 30+ Days Ago
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.
For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies.
By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.#J-18808-Ljbffr