Director, Quality Assurance Salary at East Coast Seafood Inc BETA

Job Type Full-time Description Title: Director Quality Assurance Operations Marengo Therapeutics is pioneering first-in-class therapeutics that activate the right immune response to promote lifelong protection against cancer. Marengo has uncovered a novel approach to T cell activation by targeting the V TCR chain to unleash rapid, potent, and long-lasting anti-tumor immune responses safely and effectively. We're leveraging our versatile, proprietary bispecific fusion protein platform to selectively deliver the right activation to the right T cell subsets, customizable to patient needs with its tunable properties, with an initial focus on advanced solid tumors and broad applicability beyond. Marengo is driven by core values that guide our company's mission and approach from the inside out: we demonstrate an unparalleled commitment to patients and their loved ones, we are confident in our science and our team, we operate with courage, and we creatively apply deep expertise to new ways of

Seaport Therapeutics is seeking an experienced Associate Director, QA CMC to manage GMP quality assurance activities supporting clinical development programs, ensuring compliance with Good Manufacturing Practice (GMP), regulatory requirements, and company policies. This role is instrumental in supporting clinical trials, advancing the development of innovative products, and maintaining a culture of quality across the organization. This position requires a presence in the Seaport area of Boston, with a strong preference for being onsite 3 - 4 days per week to foster collaboration and effective leadership as the Quality function is established. The role will report to the VP, Head of Quality. Seaport Therapeutics has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph p

nChroma Bio is a pioneering biotechnology company redefining the future of in vivo targeted genetic medicine to treat a wide array of diseases and bring cures to patients. The company's integrated product engine tackles significant limitations of existing genetic medicine approaches by enabling safe, precise and specific in vivo delivery. nChroma's near clinical-stage development candidate, CRMA-1001, is a liver-targeted therapy in development as a potential functional cure for chronic hepatitis B and hepatitis D that leverages the power of epigenetics, nature's innate mechanism for gene regulation. Guided by a world-class team at the forefront of genetic medicine, founded by renowned pioneers in the field, and supported by top-tier investors, the company is uniquely positioned to deliver groundbreaking therapies with programmable tissue specificity, unlocking highly potent, durable and targeted gene regulation for the liver and beyond. We're building a culture and organization to supp

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S. Position Summary: Working in a virtual pharmaceutical company, as a Sr. Manager/ Associate Director of QA GMP you will ensure compliance with Health Authority regulations and industry standards. You will be responsible for managing the GXP vendor audit and oversight program including planning and performing, as needed, external and internal GMP

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resourc

Location: This role is based in the Lexington, MA area with a hybrid schedule of four days on-site and one day remote. We are looking for an experienced Senior Director of Quality Assurance to join a dynamic team. Reporting directly to the VP and Head of Quality, this role will be instrumental in developing, overseeing, and maintaining compliance standards across key third-party partnerships and within the organization’s internal Quality systems. This position holds primary responsibility for ensuring adherence to GMP protocols supporting product manufacturing and distribution, while also overseeing batch disposition processes for both clinical and commercial products. Key Responsibilities: Oversee the GMP Quality Assurance team to maintain quality and compliance standards. Develop and implement Quality objectives, managing risk and ensuring cross-functional compliance. Ensure quality control for manufacturing and distribution across clinical and commercial products. Manage compliance

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 Kailera's mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You'll Do: Playing a critical hands-on role within Kailera, the Associate Director, Clinical Quality Assurance will be relied upon as Subject Matter Expert in GCP and GVP Compliance with respect to the planning, document review, execution, and close-out of Clinical Studies and related drug safety. Responsible to collaborate/support with Clinical Operations, Clinical Development, Pharmacovi

The Quality Assurance Specialist will actively contribute to the implementation and maintenance of the Quality Systems Manual and conduct GMP compliance audits as directed. The QA Specialist will have oversight of and involvement in, GMP compliance for production of Clinical Trial Material (CTM), including work performed by Contract Manufacturing Organizations (CMOs). Provide assistance in the audit and oversight of Contract Research Organizations (CROs) as directed. The incumbent will work closely with the Director, Quality Assurance to ensure company goals and objectives are met and compliance risks are identified and communicated to senior management. This position is located in Cambridge, MA. Key Responsibilities: Conduct and maintain New Employee Quality Orientation and Quality Refresher Training with primary responsibility for the Training System including documentation. Develop and contribute to Policies and SOPs in support of the Quality Systems Manual. Review and approve Polic