![GQR](https://media.trabajo.org/img/noimg.jpg)
Director, Quality Assurance Drug Product
1 month ago
Title: Director, Quality Assurance
Location: South San Francisco, CA
Hybrid: 3-4 days a week onsite
Compensation: Annual Salary of $230,000
Annual bonus of 20%
plus equity in shares of options
We are seeking an experienced professional to join our team as Director, of Quality Assurance.
This candidate will be responsible for Quality Operations and oversight of internal and external activities. As well as being responsible for the disposition of bulk and packaged/labeled drug product.
Required skills
- Responsible for the disposition of bulk and packaged/labeled drug product, including review of master and executed batch records, specifications, certificates of analysis and analytical test data for manufacturing and testing conducted at CSPs.
- Review and approve validation protocols/reports (e.g., process, method), analytical test methods, reference standard, stability protocols/reports and establishment of shelf-life.
- Support commercialization activities, including process validation, technology transfer, packaging validation, serialization and third-party logistics.
- Support the development, implementation, and enhancement of Quality Systems including disposition, vendor management, deviations, change control and CAPA.
- Perform review and closure of internal and CSP generated deviations (including OOS and OOT), change controls, and CAPAs, ensuring timely escalation and notification to leadership and compliant resolution of product-impacting quality issues.
- Provide Quality support for temperature excursions.
- Establish and ensure adherence to Quality metrics, effectively communicate status and provide strategic recommendations and improvement actions to Senior Management.
- Participate in Quality Management meetings such as Material Review Board and Quality Management Review.
- Contribute to development and revision of Quality Agreements.
- Collaborate on supplier qualification and management including supplier audits, as needed.
- Participate in internal and external inspection readiness activities.
- Contribute to CMC sections of regulatory submissions as necessary.
- Build and foster a quality mindset within Quality and throughout the company by ensuring consistent, risk-based process are employed in decision making.
Qualifications
- BS/BA degree or MS degree in a scientific discipline with at least 10+ years of pharmaceutical or biotechnology industry cGMP experience including 5+ years of experience in positions of management responsibility within Quality Assurance.
- Strong knowledge of cGMP, ICH, FDA, and EU regulations.
- Direct experience working with CSPs within the US and globally to meet disposition timelines.
- Prior global commercial experience, including process validation, packaging validation and serialization.
- Exercise sound judgement ensuring that written procedures are followed with proven ability to drive quality process improvement initiatives.
- Understanding of risk management principles and the ability to develop and implement risk mitigation plans related to product quality and safety.
- Highly collaborative team player who fosters open communication and facilitates cooperation between stakeholders.
-
Director, Quality Assurance Drug Product
1 month ago
South San Francisco, United States GQR Full timeTitle: Director, Quality AssuranceLocation: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This candidate will be responsible for Quality Operations and oversight of...
-
Director, Quality Assurance
2 weeks ago
South San Francisco, United States GQR Full timeTitle: Director, Quality Assurance (Drug Substance)Location: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This role will provide oversight of drug substance contract...
-
Director, Quality Assurance
4 days ago
san francisco, United States GQR Full timeTitle: Director, Quality Assurance (Drug Substance)Location: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This role will provide oversight of drug substance contract...
-
Director, Quality Assurance
4 days ago
san francisco, United States GQR Full timeTitle: Director, Quality Assurance (Drug Substance)Location: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This role will provide oversight of drug substance contract...
-
Clinical Quality Assurance Director
3 days ago
South San Francisco, California, United States GQR Full timePosition Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days on-siteThe Director of Clinical Quality Assurance (CQA) plays a pivotal role in overseeing that clinical trials comply with relevant GCP regulations, including FDA guidelines, international standards, and...
-
Clinical Quality Assurance Director
3 days ago
South San Francisco, California, United States GQR Full timePosition Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days onsiteThe Director of Clinical Quality Assurance (CQA) is a pivotal role that demands active engagement in ensuring that clinical trials comply with relevant GCP regulations (such as FDA, international, and...
-
Director, Clinical Quality Assurance
4 weeks ago
South San Francisco, United States GQR Full timeTitle: Director, Clinical Quality AssuranceLocation: South San FranciscoStatus: Full-time direct hire; Hybrid role 3 days a week onsiteThe Director of Clinical Quality Assurance (CQA) is a hands-on position responsible for ensuring clinical trials adhere to applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH guidelines, Standard Operating...
-
Director, Clinical Quality Assurance
4 weeks ago
South San Francisco, United States GQR Full timeTitle: Director, Clinical Quality AssuranceLocation: South San FranciscoStatus: Full-time direct hire; Hybrid role 3 days a week onsiteThe Director of Clinical Quality Assurance (CQA) is a hands-on position responsible for ensuring clinical trials adhere to applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH guidelines, Standard Operating...
-
Clinical Quality Assurance Director
4 days ago
South San Francisco, California, United States GQR Full timePosition Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days onsiteThe Director of Clinical Quality Assurance (CQA) is a pivotal role that involves active participation in ensuring that clinical trials comply with relevant Good Clinical Practice (GCP) regulations,...
-
Director, Clinical Quality Assurance
2 months ago
South San Francisco, United States Abdera Therapeutics Full timeJob DescriptionJob DescriptionWho we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively...
-
Senior Director of Clinical Quality Assurance
2 months ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a Clinical Quality Assurance...
-
Senior Director of Clinical Quality Assurance
2 months ago
South San Francisco, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a Clinical Quality...
-
Senior Director of Clinical Quality Assurance
2 months ago
South San Francisco, United States Alumis Full timeJob DescriptionJob DescriptionSalary: Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis...
-
Head of Clinical Quality Assurance
1 week ago
South San Francisco, California, United States Pliant Therapeutics Full timePliant Therapeutics is a leading biopharmaceutical organization dedicated to the innovation and advancement of groundbreaking treatments for fibrotic diseases. Established by Third Rock Ventures alongside esteemed academic experts, Pliant is committed to addressing the critical medical needs of healthcare providers, patients, and families affected by...
-
South San Francisco, United States Pliant Therapeutics Full timeThe client is a biopharmaceutical company in the late stages of development, dedicated to discovering and creating innovative treatments for fibrotic diseases. As a leading force in the development of novel therapies for fibrotic diseases, the client focuses on creating small molecule drug candidates specifically designed to target and influence the fibrotic...
-
Associate Director, Clinical Quality Assurance
3 months ago
South San Francisco, United States Remegen Biosciences, Inc. Full timeJob DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...
-
Director of Quality Assurance
3 weeks ago
San Jose, United States BioTalent Full timeJob Description: Director of Quality Assurance - Medical Device CompanyLocation: Bay AreaPosition Overview: We are seeking an experienced and highly motivated Director of Quality Assurance to lead and manage our quality systems in a dynamic, venture capital-backed medical device environment. The ideal candidate will have a strong background in hosting FDA...
-
Director of Quality Assurance
3 weeks ago
San Jose, United States BioTalent Full timeJob Description: Director of Quality Assurance - Medical Device CompanyLocation: Bay AreaPosition Overview: We are seeking an experienced and highly motivated Director of Quality Assurance to lead and manage our quality systems in a dynamic, venture capital-backed medical device environment. The ideal candidate will have a strong background in hosting FDA...
-
Head of Clinical Quality Assurance
1 week ago
South San Francisco, California, United States GQR Full timePosition: Clinical Quality Assurance DirectorLocation: South San FranciscoEmployment Type: Full-time direct hire; Hybrid role with 3 days onsiteThe Clinical Quality Assurance Director is a pivotal role focused on ensuring that clinical trials comply with relevant GCP regulations (such as FDA, international, and country-specific guidelines), ICH standards,...
-
Head of Clinical Quality Assurance
3 days ago
South San Francisco, California, United States GQR Full timePosition: Clinical Quality Assurance DirectorLocation: South San FranciscoEmployment Type: Full-time direct hire; Hybrid role with 3 days onsiteThe Clinical Quality Assurance Director is a pivotal role that demands a proactive approach to guarantee that clinical trials comply with relevant GCP regulations (such as FDA, international, and country-specific),...