- Ensure compliance with cGXP regulations while overseeing the continual evaluation and advancement of quality standards and requirements.
- Oversee the design, development, roll-out and maintenance of a Global GxP e-Quality Systems in alignment with current business processes.
- Oversee the corporate cGxP training program and training records. Work with department heads to develop training curriculums for all GxP personnel.
- Drive the corporate cGxP document management program. Ensuring the workflows and documents are aligned in the Veeva Quality Vault.
- Ensure the e-QMS Veeva Vault is maintained in accordance with current regulatory compliance requirements and meets current corporate quality and business objectives.
- Determine drug development phase appropriate quality system program elements.
- Will define and generate quality performance and compliance metrics.
- Develop, establish write and implement QA SOPs and supporting documentation as necessary.
- Promote Quality and GxP awareness across the organization including training initiatives.
- Facilitate the development and maintenance of quality systems supporting pre-clinical, clinical, manufacturing and distribution activities.
- Represent QS in departmental or team meetings.
- Interact effectively with company management, internal departments and other sites to effectively implement and maintain the company QMS.
- Foster a culture of accountability with progressively increased empowerment.
- Bachelor's degree in Life Sciences, or related field
- Experience with Veeva Quality Vault eDMS/eQMS and Compliance Wire eLMS required
- Worked in an FDA regulated environment and familiar with Health Authority regulations and guidance
- Minimum of 10-12 years with increasing levels of responsibility in cGMP/Quality Management Systems
- Highly Proficient in Word, Excel, and PowerPoint – Smartsheet and SharePoint are a plus
- Ability to work effectively on multiple projects simultaneously with minimum supervision
- Strong interpersonal and communication skills
- Ability to design and implement global business processes/policies with a critical thinking approach and enterprise mindset
- Strong written and verbal communication skills
- Effective/concise communicator with management and internal teams
- Experience with working in start-up environments moving in rapid growth/manufacturing
-
Director, Quality Systems
2 weeks ago
Stratacuity: Proven Scientific Placement Boston, United StatesLocation: Boston,MA (Hybrid / Onsite) · Therapeutic Area: Small molecule Pharma · Job Overview: The role requires leading the development, design, and maintenance of the Quality System to ensure efficiency, effectiveness, and compliance with quality regulations and standards, rep ...
-
Associate Director – Quality Systems
6 days ago
Monte Rosa Therapeutics Boston, United StatesAssociate Director – Quality Systems · Location: Boston, MA · Role Summary: · Monte Rosa Therapeutics is seeking a passionate Associate Director/Director of Quality Systems is responsible for maintaining and maturing Monte Rosa Tx's GxP Quality System, which includes, but is not ...
-
Director, Quality Management Systems
3 weeks ago
Stratacuity Boston, United StatesLocation: Boston,MA(Hybrid / Onsite) · Therapeutic Area: Small molecule Pharma · Job Overview: The role requires leading the development, design, and maintenance of the Quality Management System to ensure efficiency, effectiveness, and compliance with quality regulations and st ...
-
Director, Quality Systems
3 weeks ago
Ironwood Pharmaceuticals Boston, United StatesIronwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription ...
-
Director, Quality Systems
2 weeks ago
Ironwood Pharmaceuticals Boston, United StatesIronwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription ...
-
Director, Quality Systems
2 weeks ago
Ironwood Pharmaceuticals Boston, United StatesIronwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription ...
-
Director, Quality Systems
1 week ago
Stratacuity Boston, United StatesLocation: Boston,MA(Hybrid / Onsite) · Therapeutic Area: Small molecule Pharma · Job Overview: The role requires leading the development, design, and maintenance of the Quality System to ensure efficiency, effectiveness, and compliance with quality regulations and standards, re ...
-
Director, Quality Systems
2 weeks ago
Vertex Pharmaceuticals Boston, United StatesDirector, Quality Systems & Vendor Management Cell and Gene (Hybrid) page is loaded · Director, Quality Systems & Vendor Management Cell and Gene (Hybrid) · Apply · locations · Boston, MA · time type · Full time · posted on · Posted 3 Days Ago · job requisition id · REQ ...
-
Director, Quality Systems
2 weeks ago
Stratacuity Boston, United StatesLocation: Boston,MA(Hybrid / Onsite) · Therapeutic Area: Small molecule Pharma · Job Overview: The role requires leading the development, design, and maintenance of the Quality System to ensure efficiency, effectiveness, and compliance with quality regulations and standards, re ...
-
Director, Quality Systems
1 week ago
Ironwood Pharmaceuticals Boston, United StatesIronwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription ...
-
Director, Quality Systems
2 weeks ago
Fusion Pharmaceuticals LLC Boston, United StatesFusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting ...
-
Director, Quality Systems
2 weeks ago
Fusion Pharmaceuticals LLC Boston, United StatesFusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting ...
-
Director, Quality Systems
1 week ago
Stratacuity Boston, United StatesLocation: · Boston,MA · (Hybrid / Onsite) · Therapeutic Area: · Small molecule Pharma · Job Overview: · The role requires leading the development, design, and maintenance of the Quality System to ensure efficiency, effectiveness, and compliance with quality regulations and st ...
-
Fare System Quality Assurance Lead
1 week ago
TalentBurst Boston, United StatesTitle: QA Lead · Location: Boston, MA (Hybrid) · Duration: Multi Year Renewable Contract · Hours: 40 hours per week · Overview: · The client's new fare payment system will make paying for transit services in Massachusetts easier and more convenient with a full replacement of th ...
-
Associate Director Quality Systems
4 days ago
Monte Rosa Therapeutics Boston, United StatesAssociate Director Quality Systems · Location: Boston, MA · Role Summary: · Monte Rosa Therapeutics is seeking a passionate Associate Director/Director of Quality Systems is responsible for maintaining and maturing Monte Rosa Txs GxP Quality System, which includes, but is not ...
-
Manager-Quality Management Systems
2 weeks ago
Critical Fit Recruiting Boston, United StatesAs a Manager, Quality Management Systems you will play a crucial role in ensuring operations meet global compliance, regulatory standards, and customer requirements. This position involves a blend of quality management, regulatory coordination, project management, and collaborati ...
-
Director of Quality Systems and Compliance
1 week ago
Disc Medicine Boston, United StatesPOSITION OVERVIEW: · Reporting to the SVP of Quality, Disc Medicine is seeking an energetic and highly motivated Director of Quality Systems and Compliance who will be responsible for establishing and maintaining corporate quality systems, supportive policies, and procedures that ...
-
Manager, Quality Systems and Compliance
3 weeks ago
Vertex Pharmaceuticals Boston, United StatesJob Description: · The Quality Systems Manager is an advanced technical resource in the principles and application of quality systems and compliance. The role coordinates or executes alignment of procedures and processes related to the Quality Management System and helps drive Q ...
-
Quality Systems Senior Specialist
3 weeks ago
Vertex Pharmaceuticals Boston, United StatesJob Description: · The Quality Systems Sr. Specialist is an experienced technical resource in the principles and application of quality systems and compliance. The Quality Systems Sr. Specialist coordinates or executes activities on projects and takes a role in the execution and ...
-
Director, Quality Management Systems
1 week ago
Blackwomenintech Boston, United StatesJob#: · Job Description: · Director, QualitySystems (eQMS Veeva · Location: · Boston,MA(Hybrid / Onsite) · Therapeutic Area: · Small molecule Pharma · Job Overview: · The role requires leading the development, design, and maintenance of the Quality System to ensure efficien ...
Director, Quality Systems - Boston, United States - Fusion Pharmaceuticals
3 weeks ago
Description
Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion's growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.
Position Summary
Fusion has opened the role in Quality Assurance for a Director, Quality System (QS). The successful candidate will be responsible for leading the development, design and maintenance of the Quality System with the goal of maximizing efficiency, effectiveness and compliance with all appropriate quality regulations and standards of practice. This role will report to the Head of Quality Assurance.
Key Responsibilities
Required Qualifications
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.
