Current jobs related to Quality Assurance Manager, GCP - Morrisville - WEP Clinical
-
Pharmaceutical Quality Assurance Manager
60 minutes ago
Morrisville, United States SynergenX Full timeJob DescriptionJob DescriptionTomorrowMed Pharma is a pioneering 503B manufacturing facility poised to revolutionize the pharmaceutical compounding industry. Situated in the heart of Research Triangle Park in Raleigh, NC, this brand-new cutting-edge cGMP facility adheres to strict regulatory standards set by the FDA to ensure the safety, efficacy, and...
-
Quality Assurance Specialist
5 days ago
Morrisville, United States Innova Solutions Full timeJob Description:The Quality Associate II (Contractor) is responsible for contributing to the oversight of key strategic and operational aspects within Quality Assurance at Innova Solutions. Activities include but are not limited to a review of GMP raw data for compliance.Key Responsibilities:Perform all duties in a manner consistent with site and corporate...
-
Quality Assurance Architect
1 week ago
Morrisville, United States Haavia, Inc. Full timePosition Summary: Haavia, Inc. is seeking a proficient Quality Assurance Architect to spearhead the quality assurance methodologies and frameworks aimed at ensuring superior product delivery.Primary Duties:Establish and uphold a thorough quality assurance framework.Work collaboratively with teams to devise effective testing methodologies.Introduce automated...
-
Quality Assurance Validation Manager
5 days ago
Morrisville, United States Liquidia Corporation Full timeLiquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT®...
-
Quality Assurance Specialist
24 hours ago
Morrisville, North Carolina, United States Xylem Full timeAbout the RoleXylem is seeking a highly skilled Quality Assurance Specialist to join our team at our Morrisville facility. As a key member of our Quality department, you will play a critical role in ensuring that our products meet the highest standards of quality and performance.Key ResponsibilitiesLead the Inspection Lab, maintaining a high level of...
-
Product Quality Assurance Specialist II
1 week ago
Morrisville, North Carolina, United States Teleflex Full timePosition Title: Product Quality Assurance Specialist IILocation: Morrisville, NC, USCompany: TeleflexTravel Requirement: Up to 10%About Teleflex Incorporated:Teleflex is a leading global provider of medical technologies, committed to enhancing the health and quality of life for individuals worldwide. Our mission is to be the most trusted partner in...
-
414 - Quality Assurance Coordinator
21 hours ago
Morrisville, United States LSG Sky Chefs Full timeAbout us LSG Sky Chefs is one of the world’s largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approach in the industry. Voted “Airline Caterer of the Year in North America” for 2023 and 2024, we are committed to excellence and innovation, driven by the dedication and expertise of our talented...
-
Morrisville, North Carolina, United States Ad Astra Diagnostics Full timeJob OverviewAd Astra Diagnostics, Inc. (AAD) is seeking a skilled Software Quality Assurance Engineer to contribute to the development of an innovative Point-of-Care diagnostic platform tailored for the healthcare sector. You will be part of a small, agile team focused on delivering excellence.Key ResponsibilitiesLead the testing initiatives for Medical...
-
414 - Quality Assurance Coordinator
9 hours ago
Morrisville, United States LSG Sky Chefs Full timeAbout us LSG Sky Chefs is one of the world’s largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approach in the industry. Voted “Airline Caterer of the Year in North America” for 2023 and 2024, we are committed to excellence and innovation, driven by the dedication and expertise of our talented...
-
414 - Quality Assurance Coordinator
3 hours ago
Morrisville, United States LSG Sky Chefs Full timeAbout us LSG Sky Chefs is one of the world’s largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approach in the industry. Voted “Airline Caterer of the Year in North America” for 2023 and 2024, we are committed to excellence and innovation, driven by the dedication and expertise of our talented...
-
Morrisville, North Carolina, United States Ad Astra Diagnostics Full timeJob OverviewAd Astra Diagnostics, Inc. (AAD) is seeking a skilled Software Quality Assurance Engineer to contribute to the development of an advanced Point-of-Care diagnostic platform aimed at the human market. You will be part of a small, agile team dedicated to excellence.Key ResponsibilitiesLead the testing efforts for Medical Device Software, focusing on...
-
Morrisville, North Carolina, United States Ad Astra Diagnostics Full timeJob OverviewAd Astra Diagnostics, Inc. (AAD) is seeking a skilled Software Quality Assurance Engineer to contribute to the development of an advanced Point-of-Care diagnostic platform aimed at the human market. This role is essential within our agile and innovative team.Your primary responsibility will be to oversee the testing of Medical Device Software,...
-
Morrisville, North Carolina, United States Ad Astra Diagnostics Full timeJob OverviewAd Astra Diagnostics, Inc. (AAD) is seeking a skilled Software Quality Assurance Engineer to contribute to the development of an advanced Point-of-Care diagnostic platform tailored for the healthcare sector within a small, agile team.Key ResponsibilitiesLead the testing initiatives for Medical Device Software, focusing on data communication...
-
Morrisville, North Carolina, United States Ad Astra Diagnostics Full timeJob OverviewAd Astra Diagnostics, Inc. (AAD) is seeking a skilled Software Quality Assurance Engineer to contribute to the development of an innovative Point-of-Care diagnostic platform aimed at the human market within a collaborative and agile team environment.You will take the lead in testing Medical Device Software, focusing on data communication...
-
Morrisville, North Carolina, United States Ad Astra Diagnostics Full timeJob OverviewAd Astra Diagnostics, Inc. (AAD) is seeking a skilled Software Quality Assurance Engineer to play a pivotal role in the development of an advanced Point-of-Care diagnostic platform tailored for the healthcare sector within a small, agile team.You will spearhead the testing initiatives for Medical Device Software, focusing on data communication...
-
Quality Assurance Team Leader
1 week ago
Morrisville, North Carolina, United States Inotiv Full timePosition Summary:Inotiv is seeking a Quality Assurance Team Leader to oversee our QA operations at the RTP facility.Key Responsibilities:Primary Duties Supervise the Quality Assurance (QA) team and manage related projects, schedules, and financial plans. Oversee QA initiatives, projects, and timelines linked to the Inotiv RTP Validation Program. Conduct...
-
Quality Operations Manager
1 week ago
Morrisville, North Carolina, United States Jobot Full timeCompensation Package: Bonus + Equity + 401(k) + Remote WorkAbout Us:We are an innovative therapeutics organization with a market-approved drug, utilizing advancements in B-cell biology to create groundbreaking treatments for patients.Why Consider This Opportunity? Attractive Salary Annual Performance Bonus Equity Options (RSUs) 401k Retirement Plan Flexible...
-
414 - Quality Assurance Coordinator
1 day ago
Morrisville, NC-, United States LSG Sky Chefs Full timeAbout us LSG Sky Chefs is one of the world’s largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approach in the industry. Voted “Airline Caterer of the Year in North America” for 2023 and 2024, we are committed to excellence and innovation, driven by the dedication and expertise of our talented...
-
Quality Operations Manager
1 week ago
Morrisville, North Carolina, United States Jobot Full timeCompensation Package: Bonus + Equity + 401(k) + Remote Work OptionsAbout Us:We are an innovative therapeutics firm with a market-approved medication, utilizing advancements in B-cell biology to create groundbreaking treatments for patients.Why Work With Us? Competitive Salary Structure Annual Performance Bonuses Equity Opportunities (RSUs) 401k Retirement...
-
Quality Operations Manager
1 week ago
Morrisville, North Carolina, United States Jobot Full timeCompensation Package + Equity + Retirement Plan + Remote WorkAbout Us:We are an innovative therapeutics firm with a market-approved drug, utilizing advancements in B-cell biology to create groundbreaking treatments for patients.Why Work With Us? Competitive Salary Annual Performance Bonus Equity Opportunities (RSUs) 401k Retirement Plan Remote Work...
Quality Assurance Manager, GCP
1 month ago
Join our growing team at WEP Clinical, where innovation, collaboration, and a unwavering commitment to patient treatment converge. We're looking for team-players that are ambitious and eager to take initiative. If you're excited about shaping the future of clinical research, while placing patients at the heart of everything you do, explore the opportunities awaiting you with us. Apply today and be a catalyst for positive change
Role Objectives
The Quality Assurance Manager, GCP is responsible for maintenance and compliance of the Quality Management System by application of quality principles and GCP regulatory requirements. This role will support global operations, including clinical services rendered, supporting key stakeholders within the business.
The Ideal Candidate:
- Strong Communicator
- Organized
- Takes Initiative
- Strong Attention to Detail
Essential Job Duties and Responsibilities
- Responsible for ensuring the license provisions are observed and met of the WEP Clinical site.
- Responsible for ensuring that a compliant quality system is established and maintained.
- Provide Quality support to the business, championing compliance to GCP, regulatory, and company expectations.
- Responsible for ensuring that adequate resource and capabilities exist within the quality assurance team and that all personnel are trained and developed in line with the requirements of their role.
- Identify risks and take necessary preventive measures pro-actively.
- Ensure that WEP Clinical operations do not compromise patient safety and/or the quality of supplied drug products.
- Review, support, and drive initiation and completion of key quality records such as Change Controls, Deviations/Non-Conformances, CAPAs, supplier qualifications, vendor qualifications, and risk assessments.
- Support the validation of all systems (equipment and computer) as required by GxP regulations.
- Point of escalation for issues related to clinical sites, vendors/third party contractors, liaising with other business stakeholders to drive the operational quality from vendors/third party contractors
Qualifications
- Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
- 4+ years of related industry experience (must be within a GCP setting)
- Previous managerial/leadership experience within pharmaceutical or life sciences industry
What We Offer:
- Medical, dental, and vision insurance
- Short-term disability insurance
- Life insurance
- Voluntary Long-term disability insurance
- 401K safe harbor plan and company match
- Paid vacation, holiday, sick, and volunteer time
- Paid maternity & paternity leave
- Personal Development Allowance
What sets us apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over a decade of experience distributing products worldwide to treat unmet patient needs.
We're Committed to Our Team:
WEP has many initiatives in place to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, all that we do to support our employees.
We're Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.
Our services include:
Expanded Access Programs (EAPs)
Open Label Extension Studies (OLE)
Named Patient Programs (NPPs)
Clinical Trial Supplies (Comparator & Ancillaries)
Wren Nursing (Clinical Trial Home Nursing & Clinical Education)
Hospital Supply of Unlicensed Medicines
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
