Director, Quality Salary at Tracy's Partylite 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

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

KE Camps is the leading provider of summer camps for country clubs nationwide. We partner with over 230 private clubs all over the country to implement traditional-style day camps for elementary-aged children. Our Staff are the backbone of our programs and therefore, we pride ourselves on giving them an incredible amount of support. As a staff member, we guarantee you will feel a part of the KE Camps Team! As a Camp Director, you will be the go-to person for all things camp at your specific country club location. Your job will include many responsibilities, all with the goal of creating a memorable and meaningful camp experience for your campers. Our Camp Directors have real ownership over their camp programs and enjoy infusing their own creativity and talents into their weekly schedules. As you manage campers, their families, club logistics, your small staff team and other camp happenings, you will be truly supported by the KE Camps Year-Round Office all the way. Camp Director Qualiti

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