- Support implementation and management the Maze Quality Systems including document control, change management, deviation, investigation/CAPA, training, and vendor management
- Support implementation and validation of an eQMS system for document management, quality processes, and training.
- Review CMC sections of IND, IMPD and other regulatory submissions.
- Provide QA oversight and support to CMOs and CTLs including facilitation of QA to QA discussions.
- Represent QA in CMC teams, projects, and collaborate with cross functional teams.
- Author, review, and approve GXP SOPs, work instructions, and any other controlled documents in collaboration with key development functions and stakeholders.
- Support vendor management and qualification activities for cGMP service providers, including conducting supplier audits.
- Review executed batch records, master batch records, analytical method validations, and tech transfers.
- Disposition clinical drug substance/API and drug product.
- Lead investigations into quality events, deviations, and non-conformances.
- Conduct training sessions for Maze staff, as needed.
Skills and Qualifications: - Bachelor's degree in a scientific discipline with 5+ years of relevant experience in pharmaceutical quality assurance and compliance.
- Demonstrated in-depth experience of implementing and managing quality systems.
- Strong and demonstrated understanding of U.S. Code of Federal Regulations, European regulations, and any other relevant global GXP regulations.
- Proven track record of effective collaboration on internal teams, personnel, and external partners
- Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others.
- Willingness to travel for critical on-site activities and relevant QA or vendor oversight activities.
About Maze TherapeuticsMaze Therapeutics is a biopharmaceutical company that is harnessing the power of human genetics to transform the lives of patients, with a focus on genetically informed therapies for common diseases, such as chronic kidney disease, and seeks to focus expertise and resources towards underserved communities. Maze applies variant functionalization in tandem with advanced data science methods and a robust suite of research and development capabilities to advance a pipeline of novel precision medicines. Maze has developed the Maze Compass PlatformTM, a proprietary, purpose-built platform to understand and integrate the critical step of variant functionalization into each stage of drug development. Utilizing the Maze Compass PlatformTM, Maze is building a broad portfolio of wholly owned and partnered programs. Its two lead programs are focused in Chronic Kidney Disease (CKD), a condition that impacts an estimated 37m individuals. The first program in CKD addresses a genetic subset of the common disease that has a disproportionate impact on the Black Community. Maze is based in South San Francisco.
Our People
Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.
Our Core Values
Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission.
Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.
Stand True – Our integrity is foundational; it guides us no matter the obstacle.
The expected annual salary range for employees located in the San Francisco Bay Area is $170,000 - $205,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.
Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.
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Senior Manager, Quality Assurance - South San Francisco, United States - Maze Therapeutics
Description
The Position:
Are you ready to make a real difference in patients' lives and thrive in a fast-paced team-oriented environment? We're on a mission to revolutionize healthcare through the power of human genetics, and we need a talented and highly motivated Senior Manager of Quality Assurance (QA) to join our team. In this pivotal role, you'll ensure the quality and compliance of our clinical development pipeline and studies. Reporting to the Director of QA, you'll have a direct impact on the success of our projects and the overall quality of our products. You will lead the development and management of our quality management system and act as the quality representative in CMC teams providing oversight related to GMP activities. Your responsibilities will include implementing and managing the Maze quality systems, reviewing regulatory submissions, providing QA GMP oversight.
Your Impact:
Senior Manager, Quality Assurance professionals in South San Francisco
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