Associate Director, Clinical Quality Compliance
hace 1 mes
Job Title: Associate Director, Clinical Quality Compliance
Location: Cambridge, MA
About the role:As the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. You will maintain a state of control by implementing monitoring and control systems that ensure the quality systems supporting the clinical trial delivery are aligned with applicable regulations. You will report to and act as a strategic expert to the Head of GCP Quality Compliance in developing GCP Compliance strategies, managing operational activities, and building capabilities within the GCP Compliance function.
How You Will Contribute:Partner with different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting investigations and developing adequate corrective and preventive actions (CAPAs).Lead the clinical trial delivery system inspection readiness program, ensuring inspection readiness, driving accountability and transparency.Provide insights to latest requirements, operational and compliance metrics, identify quality and compliance inspection risks, and provide tactical directions in the mitigation.Host GCP inspections and provide strategic direction to relevant responsibilities and Subject Matter Experts (SME).Ensure a communication plan is in place that enables knowledge sharing of insights and risks, and timely escalates to management.Lead inspection response activities, ensuring the responses are adequate and submitted on time.Oversee the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late.Be a Subject Matter Expert (SME) on Clinical Quality Compliance activities including deviation management, quality investigation, and CAPA management.Support and provide relevant guidance to non-GCP specific inspections (e.g., GVP, GMP).Lead complex quality investigations improving the clinical trial delivery systems.Develop lessons learned from regulatory inspections and promote knowledge management.Lead improvement projects that ensure compliant quality systems in the clinical trial delivery quality systems.Approve controlled procedures related to clinical trial delivery quality systems.Escalate issues of potentially critical non-compliance to senior management.Develop and monitor relevant metrics and Main Performance/Quality Indicators (KPI/KQI).Contribute to relevant quality and compliance governance in Takeda.What you bring to Takeda:BSc in a scientific or allied health/medical field (or equivalent degree).Minimum of 10 years of relevant experience in the global pharmaceutical industry, with at least 5 years in GCP Quality/Compliance.Experience with pharmaceutical development, medical affairs and GCP/GVP regulations.Experience in implementing a clinical or pharmacovigilance audit program.Experience managing complex organizational compliance issues and implementing compliance projects.Important Considerations:At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities. You may:
Wear personal protective equipment (PPE) and other clean room garments daily.Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.Work in a cold, wet environment.Work multiple shifts, including weekends, or be asked to work supplemental hours.Work around chemicals that may require respiratory protection.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
#J-18808-Ljbffr
-
Clinical Quality Compliance Director
hace 4 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completopbAbout the Role:/bbrAs the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and knowledge management. You will maintain a state of control by implementing monitoring and control systems that ensure the...
-
Senior Clinical Quality Compliance Manager
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoAbout the RoleAs the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and knowledge management.Key ResponsibilitiesPartner with different functions to identify systemic quality and compliance risks,...
-
Director, Quality Assurance Lead
hace 3 semanas
Puerto Diablo Barrio, Puerto Rico Icon Clinical Research A tiempo completoDirector, Quality Assurance LeadAt ICON Clinical Research, we're seeking a highly skilled Director, Quality Assurance Lead to join our team. As a key member of our quality assurance department, you will play a pivotal role in ensuring the quality and compliance of clinical trials.Key Responsibilities:Develop and implement quality assurance strategies and...
-
Senior Director, Quality Compliance
hace 3 meses
Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completoSenior Director, Quality Compliance & Systems About the Company Popular provider of infant nutrition products IndustryHealth, Wellness and Fitness TypePrivately Held, VC-backed Founded2016 Employees201-500 Funding$101-$200 million Categories Health CareNutritionWellnessHealth & WellnessHealth and WellnessConsumer GoodsFood ProductionHealthCompliance &...
-
Associate Director, Medical Writing
hace 1 mes
Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completoAssociate Director, Medical Writing About the Company Well-established pharmaceutical company IndustryPharmaceuticals TypePrivately Held About the Role The Company is in search of an Associate Director for Medical Writing to join their team. The successful candidate will play a key role in the creation and management of high-quality regulatory and clinical...
-
Associate Director, Quality Control
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoAssociate Director, Quality Control Reporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen's pipeline. In addition, this position will be required to actively support the preparation of regulatory...
-
Associate Director, Quality Systems
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoVerve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic...
-
Senior Quality Systems Director
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob OverviewVerve Therapeutics is seeking an experienced Associate Director, Quality Systems to lead the development, implementation, and maintenance of a comprehensive GxP Quality Management System. This individual will collaborate with Quality Operations, Quality Control, Technical Operations, Clinical Operations, and R&D to establish, review, revise, and...
-
Associate Director, Registration
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoThe Associate Director is responsible for providing leadership, strategic direction, and vision to the Access and Financial Engagement team with a focus on the 24-hour day-to-day operations of inpatient and outpatient registration, including patient pre-registration, insurance verification, and face-to-face interviews. The Associate Director will ensure a...
-
Head of Clinical and Safety Quality Compliance
hace 3 semanas
Puerto Diablo Barrio, Puerto Rico Biospace, Inc. A tiempo completoJob Title: Head of Clinical and Safety Quality ComplianceAt Biospace, Inc., we are seeking a highly skilled and experienced professional to lead our Clinical and Safety Quality Compliance team. As the Head of Clinical and Safety Quality Compliance, you will be responsible for providing quality oversight of our clinical research, pharmacovigilance, and...
-
Head of Global Clinical and Safety Quality Compliance
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Biospace, Inc. A tiempo completoJob Title: Head of Global Clinical and Safety Quality ComplianceAbout the role:Leads the global Clinical, Pharmacovigilance, and Medical Quality Compliance organization, providing quality oversight of the quality systems supporting clinical research, pharmacovigilance, and medical activities across the enterprise.Main Responsibilities:Provides quality...
-
Director, Clinical Scientist, Respiratory
hace 3 meses
Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completoDirector, Clinical Scientist, Respiratory About the Company Respected biotechnology company IndustryBiotechnology TypePrivately Held About the Role The Company is in need of a Director, Clinical Scientist with a focus on respiratory conditions to play a key role in the scientific planning and execution of clinical trials, particularly in the areas of chronic...
-
Director Of Quality And Safety
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoThe Director for Quality and Safety for the Department of Obstetrics and Gynecology directs quality and safety efforts in both inpatient and ambulatory settings. The Director will report directly to the Department Chair and will collaborate with the Vice Chairs of Clinical Operations, DEI, and Research to optimize and oversee the quality and safety...
-
Associate Director, Biostatistics
hace 1 mes
Puerto Diablo, Puerto Rico Buscojobs PR C2 A tiempo completoAssociate Director, Biostatistics About the Company Top-tier biopharmaceutical company IndustryPharmaceuticals TypePrivately Held About the Role The Company is in search of an Associate Director, Biostatistics to join their team. The successful candidate will play a key role in the development of innovative therapies, particularly for rare diseases. Primary...
-
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoAssociate Director/Director, Development Program Management Boston, MA, USA Req #303 Tuesday, August 13, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with...
-
Director Of Quality And Safety
hace 1 mes
Puerto Diablo, Puerto Rico Boston Medical Center A tiempo completoThe Director for Quality and Safety for the Department of Obstetrics and Gynecology directs quality and safety efforts in both inpatient and ambulatory settings. The Director will report directly to the Department Chair and will collaborate with the Vice Chairs of Clinical Operations, DEI, and Research to optimize and oversee the quality and safety...
-
Process Chemistry Adc
hace 1 mes
Puerto Diablo, Puerto Rico Al Solutions A tiempo completoWe are seeking an experienced Associate Director or Director of Process Chemistry for Antibody-Drug Conjugates (ADC) to join our Biopharmaceutical Development team. In this critical role, you will lead the development and optimization of synthetic routes for ADC production, ensuring high quality and efficiency in our drug development processes. Your key...
-
Director of Quality Assurance and Compliance
hace 2 semanas
Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completoJob Title: Vice President of Quality and Regulatory AffairsJob Summary:Strand Therapeutics is seeking a highly experienced Vice President of Quality and Regulatory Affairs to join our team. This individual will be responsible for leading the development and implementation of quality management systems, ensuring compliance with global regulations, and...
-
Laboratory Quality and Compliance Specialist
hace 3 semanas
Puerto Diablo Barrio, Puerto Rico Boston Medical Center A tiempo completoJob SummaryThe Laboratory Quality and Compliance Coordinator will support the Quality and Compliance Specialist in ensuring compliance with regulations of the AABB and FDA for Blood Bank, CLIA, CAP, and JCAHO, NCCLS, HCFA, OSHA, DPH, HIPAA, and all payers. This role will also be responsible for data collection, project management, documentation, and support...
-
Anesthesia Associate Srna Program Director
hace 1 mes
Puerto Diablo, Puerto Rico Jobleads-Us A tiempo completoJob Description - ANESTHESIA ASSOCIATE SRNA PROGRAM DIRECTOR (3300019)ANESTHESIA ASSOCIATE SRNA PROGRAM DIRECTOR - (3300019)GENERAL OVERVIEW The Assistant SRNA Program Director is responsible for the development, implementation, and evaluation of the SRNA educational program. The Assistant SRNA Program Director provides clinical and didactic support to the...