- Ensure compliance with cGXP regulations by evaluating and advancing quality standards
- Oversee the design, development, and maintenance of Global GxP e-Quality Systems aligned with business processes
- Manage the corporate cGxP training program and collaborate with department heads to develop training curriculums for GxP personnel
- Bachelor's Degree in Life Sciences or a related field
- A minimum of 10-12 years of increasing responsibility in cGMP/Quality Management Systems
- Experience with Veeva Quality Vault eDMS/eQMS and Compliance Wire eLMS
- Candidates must have prior experience in FDA regulated environments and familiarity with Health Authority regulations and guidance
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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 ...
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Associate Director – Quality Systems
2 weeks 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 ...
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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 ...
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Director, Quality Management Systems
1 week ago
Apex Systems Boston, United StatesDirector, Quality Management Systems · Location: · 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, ...
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Manager, Quality Systems and Compliance
21 hours 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 ...
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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 ...
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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 ...
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Director, Quality 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 System to ensure efficiency, effectiveness, and compliance with quality regulations and standards, re ...
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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 ...
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Director, Quality Systems
3 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 ...
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Director, Quality 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 System to ensure efficiency, effectiveness, and compliance with quality regulations and standards, re ...
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Fare System Quality Assurance Lead
1 week ago
Talentburst Inc. Boston, United StatesTitle: QA LeadLocation: Boston, MA (Hybrid)Duration: Multi Year Renewable ContractHours: 40 hours per weekOverview:The client's new fare payment system will make paying for transit services in Massachusetts easier and more convenient with a full replacement of the client's automa ...
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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 st ...
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Fare System Quality Assurance Lead
6 days ago
TalentBurst Boston, United StatesTitle: QA Lead · Location: Boston, MA (Hybrid) · Duration: Multi Year Renewable Contract · Hours: 40 hours per week · Overview: · The clients new fare payment system will make paying for transit services in Massachusetts easier and more convenient with a full replacement of ...
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Fare System Quality Assurance Lead
3 weeks 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 ...
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Evotec WD Boston, United StatesSr. Director Global Quality Management Systems page is loaded · Sr. Director Global Quality Management Systems · Apply · locations · Boston, MA · Field Based US - East Coast · Field Based US - West Coast · Cambridge, MA · Seattle · time type · Full time · posted on · ...
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Associate Director Quality Systems
2 weeks ago
Monte Rosa Therapeutics, Inc Boston, United StatesOverview: · 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 limited to documentation, training, supplier quality, internal aud ...
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Director of Quality Systems and Compliance
3 weeks 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 ...
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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 ...
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Sr. Manager QA Quality Management Systems
2 weeks ago
Pharvaris Boston, United StatesPharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients ...
Director, Quality Systems - Boston, United States - Stratacuity: Proven Scientific Placement
Description
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 efficiency, effectiveness, and compliance with quality regulations and standards, reporting to the Head of Quality Assurance.
Primary Job Responsibilities:
Primary Job Requirements:
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENTTM
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