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Confidential
Boston, MA, United States
Vice President, Quality & Controls Assurance About the Company Large community-based healthcare organization Industry Hospital & Health Care Type Non Profit Founded 2003 Employees 1001-5000 Categories Health Care Hospital Non-Profit & Philanthropy Community Health Senior Care Healthcare Medical Care Behavioral Science Support Affordable Healthcare
Job Source: ConfidentialConfidential
Boston, MA, United States
Vice President, Quality About the Company Mission-driven pharmaceutical company Industry Pharmaceuticals Type Non Profit Founded 2018 Employees 51-200 Categories Pharmaceuticals Manufacturing Health Care Non-Profit & Philanthropy Pharmacy Medicine Chemical Products About the Role The Company is seeking a Vice President Quality for its retail phar
Job Source: ConfidentialIronwood Pharmaceuticals, Inc.
Boston, MA, United States
There are jobs and there are careers. A career at Ironwood Pharmaceuticals means you’ll be part of something genuinely special. You join a community of innovators working together to meet the significant needs of patients with GI diseases. You’ll become part of a team that celebrates the unique attributes and viewpoints of each individual and encou
Job Source: Ironwood Pharmaceuticals, Inc.Ironwood Pharmaceuticals
Boston, MA, United States
Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a signific
Job Source: Ironwood PharmaceuticalsConfidential
Boston, MA, United States
Vice President, Quality About the Company Innovative pharmaceutical company with a global presence Industry Biotechnology Type Public Company Founded 1998 Employees 501-1000 Categories Health Care Biotechnology Pharmaceutical Pharmaceuticals Medicine Manufacturing Chemical Products Business Classifications B2B E-Commerce About the Role The Compa
Job Source: ConfidentialState Street Corporation
Quincy, MA, United States
This is an Exciting and High visibility Leadership role to Lead Quality Assurance for Transaction Monitoring Team. Candidate will be responsible for driving QA strategy and lead QA team to ensure Quality controls for AML Transaction Monitoring Program. Education and e xperience Qualification Bachelor's degree in Computer Science , Information S
Job Source: State Street CorporationDennis Partners
Boston, MA, United States
This clinical-stage biotech company is developing innovative treatments for multiple neurodegenerative diseases. They are seeking a Vice President (or SVP) of Regulatory & Quality to build and lead both functions, and serve as the primary contact with FDA. Reporting into the CMO, you will provide crucial input on all regulatory matters related to t
Job Source: Dennis PartnersState Street
Quincy, MA, United States
Who We Are Looking For The Software Quality Assurance Testing Engineer will play a key role in the quality assurance of Anti-Money Laundering (“AML”), Sanctions Screening, AML Transaction Monitoring, and Know Your Customer (“KYC”) suite of applications in the Boston, MA area. We are looking for someone who has proven experience with testing and au
Job Source: State StreetBoston, MA, United States
JOB TITLE: Vice President Quality Assurance
DEPARTMENT: Quality Assurance
REPORTS TO: COO
JOB SUMMARY:
Reporting to the COO, The Vice President, GxP Quality Assurance is responsible for establishing and leading Aveo’s Quality Management System (QMS) operations and ensuring compliance with Local, State, Federal, and International regulations and standards associated with GXPs and Quality Systems in a fast-paced, primarily virtual development environment.
The incumbent will lead the quality and related compliance activities for Aveo’s commercial product (s) and pipeline candidates (ranging from early to late-stage clinical trials). The VP QA will direct all GxP Quality activities and ensures Aveo and its vendors are inspection ready, adhere to GLP, GCP, GPV, GDP and GMP applicable regulations, company policies & procedures.
PRINCIPAL DUTIES:
Lead and manage a high performing quality staff designed to meet the technical and compliance requirements of an established and growing company
Lead the overall GxP compliance programs for the enterprise
Oversee the inspection readiness, risk management, and metrics & reporting programs
Lead and manage commercial QA oversight program including manufacturing, packaging and labeling, serialization, direct to practitioner sample program, third party logistics activities, to ensure compliance with DCSCA and associated regulatory requirements.
Lead and manage computer system/cloud based validation and GAMP5 activities.
Direct the maintenance of quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, GXP regulations.
Proactively oversee AVEO’s outsourced GxP activities to ensure consistent quality and compliance.
Oversight and review of partnerships/relationships with CDMO/CMO/CTL/CROs and where appropriate, manage these relationships through quality agreements
Lead the organization’s ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production.
Ensure proper management for the creation, review and modification of controlled documentation (SOPs, forms, quality agreements, controlled lists, etc…)
Lead the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external clinical, safety, quality, and regulatory standards.
Ensure establishment and maintenance of company wide training matrix.
Develop, manage and monitor adherence to the overall Quality budget
Foster a culture that values innovation, continuous improvement, and personal accountability in interactions with direct reports and others
REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):
BA/BS in Life Sciences or related discipline. Advanced degree a plus.
Minimum 15-20 years of experience in biotech/pharmaceutical industry; Minimum 10 years at a senior management level
Experience with working with and qualifying external vendors
Strong project management skills
Ability to problem-solve and provide guidance across a broad range of topics
Broad industry experience and technical background across GxP encompassing Production, Quality Assurance, Clinical Development and Quality Control
Should have an excellent understanding of Quality requirements in both the US and EU, or wherever AVEO products may be marketed/distributed
Successful track record of positive regulatory inspection outcomes and project/system implementations
Exceptional interpersonal skills including relationship building, conflict resolution and verbal and written communication are essential in this collaborative work environment
About AVEO
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Email Alert for Vice President of Quality Assurance jobs in Boston, MA, United States
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