We have other current jobs related to this field that you can find below
-
Associate Director, Quality Assurance
3 weeks ago
Cambridge, United States Proclinical Staffing Full timeProclinical is seeking a dedicated and dynamic Quality Assurance professional for the role of Associate Director. This role is a unique opportunity to contribute to the growth and evolution of our Quality function. The successful candidate will collaborate with Clinical Development colleagues, oversee external contract vendors, and contribute to the...
-
Associate Director, Quality Assurance
1 month ago
Cambridge, United States Proclinical Staffing Full timeProclinical is seeking a dedicated and dynamic Quality Assurance professional for the role of Associate Director. This role is a unique opportunity to contribute to the growth and evolution of our Quality function. The successful candidate will collaborate with Clinical Development colleagues, oversee external contract vendors, and contribute to the...
-
Associate Director/Director, Quality Assurance
4 weeks ago
Cambridge, United States Korro Bio, Inc. Full timeCompany Summary: Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body's natural RNA editing process to effect a precise yet transient...
-
Associate Director
4 weeks ago
Cambridge, United States Relay Therapeutics Full timeThe Opportunity: We are seeking a Quality professional to be a cornerstone to a growing and evolving Quality function at Relay Tx. You will partner with your Clinical Development colleagues to oversee several external contract vendors while simultaneously contributing and influencing the build of the Quality Management System as the team evolves along with...
-
Senior Quality Assurance Manager
4 days ago
Cambridge, Massachusetts, United States Relay Therapeutics Full timePosition Overview:We are in search of a Quality Assurance leader to play a pivotal role in the development of our Quality function at Relay Therapeutics. This position involves collaboration with Clinical Development teams to manage various external contract partners while actively shaping the Quality Management System as our operations expand. This...
-
Senior Director Quality Assurance
2 months ago
Cambridge, United States QurAlis Full timeABOUT THE COMPANY At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative...
-
Senior Director Quality Assurance
3 months ago
Cambridge, United States QurAlis Full timeABOUT THE COMPANY At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative...
-
Associate Director, Quality Assurance Operations
4 weeks ago
Cambridge, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic...
-
Associate Director, Quality Assurance Operations
4 weeks ago
Cambridge, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus PharmaceuticalsAlkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic...
-
Clinical Quality Assurance Senior Manager
4 days ago
Cambridge, Massachusetts, United States Moderna Therapeutics Full timeSenior Manager of Clinical Quality AssuranceChampion adherence to Good Clinical Practice (GCP) standardsOffer expert guidance on global GCP regulationsUtilize GCP knowledge to enhance the auditing frameworkCollaborate with study teams to foster a culture of quality within the organizationCore Responsibilities:Engage in the formulation of clinical quality...
-
Director, Clinical Quality
3 months ago
Cambridge, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus Pharmaceuticals:Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic...
-
Director, Clinical Quality
3 months ago
Cambridge, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus Pharmaceuticals:Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic...
-
GCP QA Senior Manager
2 months ago
Cambridge, United States Meet Full timeWe are partnering with a Massachusetts based Biotech to help them add a Manager of GCP Quality Assurance who will provide expertise and guidance on Good Clinical Practice (GCP), applicable regulations to clinical and nonclinical development teams to proactively identify compliance issues/risks and recommend mitigation.ResponsibilitiesProvide expertise in...
-
GCP QA Senior Manager
2 months ago
Cambridge, United States Meet Full timeWe are partnering with a Massachusetts based Biotech to help them add a Manager of GCP Quality Assurance who will provide expertise and guidance on Good Clinical Practice (GCP), applicable regulations to clinical and nonclinical development teams to proactively identify compliance issues/risks and recommend mitigation.ResponsibilitiesProvide expertise in...
-
Associate Director, Biostatistics
2 months ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....
-
Associate Director, Biostatistics
2 months ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....
-
Associate Director, Biostatistics
2 months ago
Cambridge, United States Bicycle Therapeutics Full timeJob DescriptionJob DescriptionCompany DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two...
-
Senior Director, Quality Control
3 months ago
Cambridge, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Clinical Quality Assurance Manager
4 days ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob OverviewCompany Overview:Bicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapies, known as Bicycle molecules, aimed at addressing unmet medical needs. These molecules are synthetic short peptides structured with small molecule scaffolds, designed to enhance target binding with exceptional affinity...
-
Clinical Quality Assurance Manager
3 days ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob OverviewCompany Overview:Bicycle Therapeutics is a pioneering biopharmaceutical organization focused on creating innovative therapies, known as Bicycle molecules, for conditions that lack effective treatments. These molecules are synthetic short peptides designed with small molecule scaffolds, forming loops that enhance their structural stability. This...
Associate Director or Director, GCP Quality Assurance
2 months ago
The clinical quality assurance AD/Director will provide support to ensure the quality and compliance of clinical studies conducted throughout Apnimed. This role will involve working cross functionally with internal and external stakeholders in support of CQA initiatives to ensure continuous improvement and quality in adherence to agency regulations and standards, GCP, industry guidelines, and Apnimed policies and procedures for the conduct of clinical studies.
The position will utilize audit and inspection intelligence, SOP development, training and risk mitigation plans to assure adherence to GCP/GVP requirements in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients. The position is accountable for the execution of Quality Assurance (QA) audit and inspection activities for assigned sponsor, investigator sites, vendors and IRB & Ethic committees in preparation for BIMO inspections. This role is responsible for GxP compliance and to ensure the adherence to Apnimed Standard Operating Procedures, Policies, and all applicable worldwide regulations and guidelines (e.g., US FDA, EU Directives, ICH).
KEY RESPONSIBILITES:
- Prepare and conduct GCP/GPV compliance audits and oversight of investigator sites and vendors.
- Generate audit reports and communicate results to relevant internal and external stakeholders.
- Interact with various teams to ensure corrective and preventative actions and QA observations are resolved and brought to closure.
- Activities may include routine and directed audits of investigator sites, vendors, regulatory documents, marketing applications, third-party collaborations, and due diligence activities.
- Actively support the development and deployment of BIMO and other Regulatory Authorities for Inspection Readiness.
- Represent Quality Assurance as subject matter expert (SME) and a single point-of-contact for guidance on clinical and data management processes
- Serve as a member of project teams with participation in the applicable forums, providing GCP compliance advice and guidance to achieve continuous quality improvement and effective quality control.
- Interfaces with relevant stakeholders including Regulatory Affairs, Clinical Operations, and development sub-teams, as appropriate to provide GCP and QA guidance.
- Contributes to the QA strategy and supports QA goals for the aligned studies in each therapeutic area and/or region.
- Collaborate with clinical operations to identify potential trends and risks to conduct QA assessments to support the implementation of associated risk mitigation strategies.
- In partnership with leadership, actively contributes to quality management oversight activities.
- Ensure appropriate and timely escalation of quality issues/events, such as potential misconduct or deviation from required Apnimed SOP’s and regulations and guidelines.
- Interface and provide day-to-day support to applicable QA line function to ensure appropriate quality oversight.
- Participate in the development and enhancement of policies and procedures to ensure compliance with applicable guidance documents.
- Assess compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents against ICH guidelines, applicable government agency regulations and guidelines, as well as company policies, procedures, and industry standards.
- Function as a strong technical resource when called upon to resolve issues based on knowledge of relevant procedures, GCP and GVP regulations and guidelines as well as local regulations.
- Promotes standardization of auditing approach.
- Design and actively participate in special assignments on various project teams and work streams as determined by management.
- Oversees training of staff involved in GCP activities and provides training and mentorship to less experienced members of QA staff.
QUALIFICATIONS:
- BS/BA degree in a related discipline with at least eight (8) years of relevant experience in the pharmaceutical industry, including conducting a broad range of GCP related audits.
- Broad and in-depth knowledge of the drug development process, GCP/GVP guidelines, and applicable regulations.
- Experience with Bioresearch Monitoring Program (BIMO) Compliance Programs and inspection readiness is required.
- Business Acumen/Mindfulness - Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
- Analytical Skills - Uses rigorous logic and methods to solve difficult problems with effective solutions.
- Communications - Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats.
- Leadership and Decision Making - Act independently to make key timely decisions with limited oversight by management. Strong ability to motivate teams to embed quality by design through the life cycle of the project.
- Creative Thinking - Strong ability to operationalize ideas proposed; frequently engages innovative ideas or ways of doing things and influences creative thinking.
- Teamwork - Strong interactive skills with the ability to work effectively in teams.
- Time Management - Ability to multi-task and manage time efficiently and effectively.
- Work and function at the highest level in a role that may be largely remote from the company offices.
WHAT APNIMED OFFERS:
- 401(k) with company match.
- Generous time off for vacation.
- Generous healthcare benefits.
- Flexible working environment.
- Motivated and experienced team.
LOCATION AND OTHER INFORMATION:
- Apnimed is a privately held company based in Cambridge, MA; while proximity to the company headquarters is valued, remote workers are encouraged to apply.
- Travel Requirement – up to 20%.
- Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment.
- Please visit us at to learn more about our work with Obstructive Sleep Apnea (OSA).