Associate Director, Quality Assurance, GMP - Boston

The Manager, GMP Quality Assurance will be responsible for supporting late-stage GMP QA activities and transitions through PPQ to commercial launch. This includes overseeing master and executed batch record review and disposition of drug substances and drug products. · Support cr ...

We are seeking a dynamic and results-driven Associate Director of GMP Quality Assurance (QA) to join our team.You will play a pivotal role in ensuring the quality,safety,and compliance of our biologics manufacturing processesand device development activities(pre-filled syringes/a ...

· At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kai ...

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailer ...

The Associate Director of GMP Quality Assurance will report to the Senior Director of GMP Quality. · ...

We're seeking an Associate Director of GMP Quality Assurance to provide quality oversight for Oruka's clinical development programs and manufacturing. · The successful candidate will ensure compliance with phase-appropriate regulatory requirements applicable guidelines industry b ...

Oruka Therapeutics seeks an Associate Director of GMP Quality Assurance to provide quality oversight for clinical development programs and manufacturing. · Provide GMP quality support and guidance · Review and approve documentation · Investigate deviations and CAPAs · ...

Xenon Pharmaceuticals is seeking an Associate Director of Quality Assurance for its GMP operations in Boston, MA. The successful candidate will have experience with global GMP regulations and principles. · ...

The GMP Operational Quality Senior Manager at Stark Pharma will oversee and ensure compliance with Good Manufacturing Practices within manufacturing and quality assurance processes. · Strong knowledge of GMP, Quality Assurance practices, and Validation processesExperience with re ...

The GMP Operational Quality Senior Manager at Stark Pharma will oversee and ensure compliance with Good Manufacturing Practices (GMP) within manufacturing and quality assurance processes. · ...

+ Job summary: Associate Director Quality Assurance · Rapport Therapeutics is seeking an Associate Director of Quality Assurance to lead quality assurance activities across both quality systems and GMP-focused operations. · + Responsibilities:Support quality oversight in a phase- ...

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This role supports commercial launch readiness by ensuring GMP Quality Systems and documentation are compliant, inspection-ready, and aligned with global regulatory expectations. · Lead GMP Quality Systems readiness activities for commercial biologics and combination productsOw ...

· enGene (NASDAQ: ENGN) is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead product candidate, detalimogene voraplasmid, is being evaluated in an ongoing pivotal study for pati ...

+Job summary · The Senior Manager, Quality Assurance, will be a key member of the Quality team, leading quality assurance activities across both quality systems and GMP-focused operations to support the advancement of global Phase 3 clinical trials for RAP-219 and other assigned ...

We're driven by a passion for developing precision neuromedicines with the potential for fewer side effects, · enabling patients and their families to enjoy healthier, more fulfilling lives. We're doing this with extraordinary science and awesome people.We have FUN. We hire smart ...

· Job Description · The GMP Operational Quality Senior Specialist Contractor supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of activities and supports new/existing project initiatives. The G ...

The GMP Operational Quality Senior Specialist Contractor supports the principles and application of quality assurance and regulatory compliance. · Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to man ...

· Perform batch record review and facility issue resolution with GMP partner sites (CDMO) · Conduct final disposition of clinical and commercial drug product, ensuring that disposition is conducted in compliance with applicable regulations and requirements. · ...

6+ month on-site assignment in Boston, MA. · W2 employees or single member LLC professionals only · No C2C/third-party vendors · OVERVIEW · Our pharmaceutical client is in need of a Quality Assurance (QA) Specialist to support their team. · This consultant will work with the QA ...