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Confidential
Boston, MA, United States
Executive Director, Quality Assurance About the Company Emerging biopharmaceutical company Industry Biotechnology Type Public Company Founded 1996 Employees 201-500 Categories Biopharma Biotechnology Genetics Health Care Medical Pharmaceutical Pharmaceuticals Medicine Chemical Products Manufacturing Consulting & Professional Services Specialties ra
Job Source: ConfidentialXenon Inc
Boston, MA, United States
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 neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive
Job Source: Xenon IncXenon Pharmaceuticals Inc.
Boston, MA, United States
Executive Director, Quality Assurance, GMP Boston, MA, USA Req #267 Monday, May 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 neurological and p
Job Source: Xenon Pharmaceuticals Inc.Apex Systems
Boston, MA, United States
Executive Director, Quality Assurance, GMP Executive Director, Quality Assurance, GMP 2034727 Location :Boston, MA (Hybrid) Science: Small Molecule Therapeutics Job Overview: The Executive Director, Quality Assurance, GMP will oversee internal and external GMP quality and leverage extensive quality and manufacturing experience from all clinical
Job Source: Apex SystemsSci-Rec
Boston, MA, United States
Head of Quality Assurance - Boston Do you want to join a growing biologics CDMO based in Boston, MA and help the team to achieve their site goals of considerable growth over the next 5 years? If so, apply below. Responsibilities: Maintaining site's Quality system in accordance with regulatory guidelines and cGXP compliance requirements; Maintaini
Job Source: Sci-RecRBW Consulting
Boston, MA, United States
RBW is partnering with an innovative biopharma company in its search for a Director of Quality. Our client has several biologics products on the market, with a strong development pipeline and is providing the right candidate with the opportunity to work with a rapidly growing organisation. The candidate will report directly to the executive team,
Job Source: RBW ConsultingPirouette Medical
Boston, MA, United States
[Full Time] Director of Quality Assurance at Pirouette Medical (United States) | BEAMSTART Jobs Director of Quality Assurance Pirouette Medical United States Date Posted 31 Oct, 2022 Work Location Boston, United States Salary Offered $150000 — $200000 yearly Job Type Full Time Experience Required 6+ years Remote Work Yes Stock Options No Vaca
Job Source: Pirouette MedicalAdaptimmune Therapeutics PLC
Cambridge, MA, United States
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Our
Job Source: Adaptimmune Therapeutics PLCBoston, MA, United States
Executive Director, Quality Assurance
About the Company
Innovative biopharmaceutical company
Industry
Biotechnology
Type
Public Company
Founded
1996
Employees
201-500
Categories
Biopharma
Biotechnology
Genetics
Health Care
Medical
Pharmaceutical
Pharmaceuticals
Medicine
Chemical Products
Manufacturing
Consulting & Professional Services
Specialties
rare disease
drug discovery
ion channels
neurology
epilepsy
drug development
orphan disease
neuroscience
biotechnology
biopharmaceuticals
seizures
focal onset seizures
and MDD
About the Role
The Company is a leading biopharmaceutical firm dedicated to the discovery and development of innovative therapeutics for a range of medical conditions. They are currently seeking an Executive Director, Quality Assurance, GMP to join their team. The successful candidate will be a pivotal member of the Quality leadership team and will play a key role in the collaborative R&D Operations group, which includes Program Management, CMC, Regulatory, and Quality functions. The role demands an individual with an extensive background in quality and manufacturing across all clinical phases to commercial, ensuring that all quality program requirements are met.The Executive Director will be responsible for all quality-related matters related to manufacturing, testing, and release at a CMO, acting as the technical subject matter expert for all GMP-related regulations and guidelines. They will lead and support activities related to external quality, collaborate with internal CMC functions, and ensure that quality policies and objectives are understood and maintained for all GMP roles. The ideal candidate should have a bachelor's degree in a life sciences discipline, with over 12 years of experience in GMP quality leadership positions, a strong understanding of small molecule manufacturing, and a proven track record of leading high-performance teams in a fast-paced, deadline-driven environment. Strong interpersonal skills, extensive GxP knowledge, and the ability to promote a quality mindset throughout the organization are essential.Candidates for this role at the company should possess a bachelor's degree in a life sciences discipline and have at least 12 years of experience in GMP quality leadership positions. A strong understanding of small molecule manufacturing, particularly in solid oral dosage, is required, and experience with a small virtual company is a plus. The role demands a leader with a strong knowledge of global GxP expectations, QP requirements, and the ability to effectively organize, multitask, and work in a fast-paced, deadline-driven environment. The successful candidate will have extensive experience in establishing key quality system metrics, strong interpersonal skills, and a proven track record of leading high-performance teams. The ability to communicate effectively and proactively, as well as being goal-oriented with a focus on continuous improvement, is essential. A proactive and solution-focused approach, as well as the ability to work with minimal supervision and influence others, are also key attributes for this role.
Hiring Manager Title
Senior Vice President, Quality Assurance
Travel Percent
Less than 10%
Functions
CEO/President
Non-Profit Management
Operations
General Management
Strategy
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Email Alert for Executive Director, Quality Assurance jobs in Boston, MA, United States
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