Director, Quality Salary at Plastic Industries 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

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

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

How you’ll contribute: Lead development and execution of the Clinical Quality strategy while ensuring that it aligns with Company’s business strategy, GCP/GLP/GVP standards, and FDA/EMA/ICH requirements Develop, implement and monitor phase appropriate GCP/GLP/GVP Quality programs, policies and procedures to ensure compliance with applicable regulations Develop, implement and execute a risk-based audit strategy for clinical and non-clinical studies Lead and manage GLP/GCP/GVP audits program including oversight of consultant mediated and/or self-conducted Vendor, System, Study, and Process audit Providing quality oversight and compliance support to all GLP non-clinical and clinical development programs including the development of strategic clinical quality oversight plans Serve as a member of clinical study teams, providing compliance guidance, to achieve continuous quality improvement and effective quality assurance Implement tolerance limits, metrics and key performance indicators to

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

Title: Director, Quality (GMP) Location: Cambridge, MA (Hybrid) Position Summary The Director of Quality & Compliance (GMP) plays a vital leadership role within the Quality & Compliance function, providing operational, regulatory, and system-level expertise for GMP-related activities. This individual will ensure that all GMP efforts-whether executed internally or through external partners-are carried out with a strong focus on patient safety, data integrity, and regulatory compliance. Key Responsibilities Lead and support GMP quality initiatives across internal teams and external collaborators (e.g., CDMOs, testing labs, etc.). Ensure consistent execution and governance of GMP compliance programs. Participate in cross-functional meetings related to CMC, clinical studies, and development programs to provide quality oversight. Maintain and organize GMP-related documentation, systems, and program records. Manage the GMP audit program, including conducting qualification audits and supporti

Director, Quality Systems Job Type: Permanent Location: Waltham, MA. Site based Salary: Up to $230K + Bonus + Benefits The company is a cutting-edge clinical-stage biotechnology company mainly dedicated to the Nephrology space. They have a dynamic pipeline of groundbreaking therapies. As the Director, Quality & Compliance, you will take a leading role in advancing and overseeing the Quality Management System to align with relevant global regulatory standards and company business goals. This position offers significant visibility within the organization. Responsibilities Oversee companywide GxP training programs, aligning training requirements with job functions. Lead the development and maintenance of the audit and inspection readiness programs. Contribute to the continuous improvement of the inspection readiness program and new initiatives. Develop, review, and monitor quality agreements and contracts. Manage GxP Training, Supplier Management, and documentation systems. Support the Qu

Position Summary: The Associate Director, Quality will be responsible for the development, management and continuous improvement of Quality Systems at Upstream to ensure its products and processes are compliant to regulatory, functional area and customer requirements. Partner with all areas of the business to understand and address their needs/issues. Interface with all areas of the business to elevate potential issues to management and drive continuous improvement efforts. Provide expertise and leadership in implementing a quality system management function for clinical and commercial products. Key Responsibilities: Provide Expertise on implementation and maintenance of the QualityManagement System (QMS), both electronic and paper based, including but not limited to SOPs, document control,product complaints, training, change management and quality event management (deviations and CAPAs) Administer documents for clinical and commercial operations that are compliant and fit for purpose.