-
Quality Assurance
4 days ago
Lazarusai Boston, United StatesLazarus AI creates dynamic, highly accurate machine learning APIs to solve the data extraction and data activation challenges of our customers. Our latest innovation, RikAI, is a large language model that extracts data from any document without training, regardless of type, forma ...
-
Quality Assurance Specialist
1 day ago
Randstad USA Boston, United StatesQuality Assurance Specialist · Pay Rate: 50-55 per hour · Shift is 6am - 6pm (3/2/2/3/2/2 schedule) · Located in Norwood, MA (100% on-site). · Quality on the floor so 75% of the time this person will be on the manufacturing floor. This is a very hands on role. · This person will ...
-
Director of Quality Assurance
2 days ago
Walker Cole International Boston, United StatesWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA. · As the Director of Quality Assurance, you will be responsible for: · Leadership of entire QA function including ...
-
Director of Quality Assurance
3 weeks ago
Albion Rye Associates Boston, United StatesDirector, Clinical Quality Assurance · Location: Boston, Massachusetts · Albion Rye Associates are partnered with one of the fastest growing US Biotech's with a rich Clinical pipeline across various indications to recruit a Director / Snr Director, Clinical Quality Assurance. · ...
-
Director of Quality Assurance
1 day ago
Sci-Rec Boston, United StatesHead 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 accorda ...
-
Quality Assurance Engineer
1 day ago
Myomo, Inc. Boston, United StatesHave you ever felt that healthcare as an industry represents opportunities for growth? That - while treatments and outcomes are more impressive than ever due to many advancements of modern medicine - the patient experience still leaves much to be desired? · Would you like to be p ...
-
Director of Quality Assurance
1 week ago
RBW Consulting Boston, United StatesRBW is partnering with an innovative Biopharma in their search for a Site Head 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 organisa ...
-
Quality Assurance Analyst
1 day ago
LanceSoft Boston, United StatesJOB SUMMARY: · The purpose of the Quality Assurance Analyst is to provide continuous test improvement and feedback to resolve issues, helping the Automated Fare Collection department meet customer and stakeholder demands by delivering properly performing products in a timely man ...
-
Director of Quality Assurance
1 week ago
Albion Rye Associates Limited Boston, United StatesDirector, Clinical Quality Assurance · Location: Boston, Massachusetts · Albion Rye Associates are partnered with one of the fastest growing US Biotech's with a rich Clinical pipeline across various indications to recruit a Director / Snr Director, Clinical Quality Assurance. · L ...
-
Quality Assurance Manager
1 day ago
United Employment Group, Inc. Boston, United StatesJob Description · Job Description · Reporting to the Director of Quality Assurance, the Quality Assurance Manager is primarily responsible for ensuring that concrete products plants are consistent in achieving and maintaining company Quality standards at the assigned concrete p ...
-
quality assurance analyst
4 days ago
HexaQuEST Global, Inc. Boston, United StatesJob Description : · The purpose of the Quality Assurance Analyst is to provide continuous test improvement and feedback to resolve issues, helping the Automated Fare Collection department meet customer and stakeholder demands by delivering properly performing products in a time ...
-
Quality Assurance Analyst
4 days ago
Innovative Development Boston, United StatesPosition Summary · The Quality Assurance Specialist will be responsible, with management support, for providing oversight of quality activities associated with drug substance, drug product and manufacturing processes to contract manufacturing organizations including technology t ...
-
Director of Quality Assurance
3 weeks ago
Albion Rye Associates Boston, United StatesDirector, Clinical Quality Assurance · Location: Boston, Massachusetts · Albion Rye Associates are partnered with one of the fastest growing US Biotech's with a rich Clinical pipeline across various indications to recruit a Director / Snr Director, Clinical Quality Assurance. ...
-
Quality Assurance Analyst
1 week ago
Rose International Boston, United StatesDate Posted: 06/10/2024 · Hiring Organization: Rose International · Position Number: 465576 · Job Title: Quality Assurance Analyst · Job Location: Boston, MA, USA, 02108 · Work Model: Hybrid · Employment Type: Temporary · Estimated Duration (In months): 9 · Min Hourly Rat ...
-
Quality Assurance Coordinator
1 week ago
Opis Senior Services Group Boston, United StatesLocation: · Boston, MA - Hybrid of On-site/Remote · Duration: · 6 month - Contract to Hire · Start: · ASAP, Flexible · Job Description: · Our client, a major academic medical center in Boston and the nation's largest hospital based research program, is looking for a Quality As ...
-
Quality Assurance Lead
1 day ago
Trillium Staffing Boston, United StatesTrillium Professional is now seeking a Quality Assurance Lead for Boston · They will lead test strategy, monitor vendor's progress towards demonstrating compliance with contractual requirements, manage QA activities, oversee test development and execution, manage the prioritizat ...
-
Quality Assurance Automation
1 week ago
State Street Corporation Boston, United StatesQuality Assurance Automation (multiple positions) (State Street Bank and Trust Company; Boston, Massachusetts): Will test State Streets proprietary, industry-leading platforms by coordinating with development, writing test cases, executing tests, contributing to building our auto ...
-
Auditor Quality Assurance
3 weeks ago
JetBlue Boston, United StatesPress Tab to Move to Skip to Content Link · Select how often (in days) to receive an alert: · Select how often (in days) to receive an alert: · Category: · Administration · Position Summary · The Quality Assurance Auditor is responsible for performing audits as required by Feder ...
-
Quality Assurance Manager
1 week ago
RADCUBE | Rapid Technology Solutions Boston, United StatesPrimary Responsibilities · • Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · • Track, measure, and report on progress identifying, writing, and executing tests, and resolving defects. · • Identify systemic p ...
-
Quality Assurance Engineer
4 days ago
MFS Investment Management Boston, United StatesAt MFS, you will find a culture that supports you in doing what you do best. Our employees work together to reach better outcomes, favoring the strongest idea over the strongest individual. We put people first and demonstrate care and compassion for our community and each other. ...
Vice President of Quality Assurance - Boston, United States - Page Mechanical Group Inc
Description
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.
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.
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.
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.
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.