Senior Manager, Regulatory Compliance
5 days ago
We are seeking a highly skilled Senior Manager/Associate Director, Quality Assurance to join our team. In this role, you will be responsible for ensuring the quality and regulatory compliance of our Small Molecule and Antibody Drug Conjugate (ADC) portfolio.
You will work closely with the Contract Manufacturing Organization (CMO) to release Intermediate/RSM, drug substance, drug product, and finished drug product. Your primary focus will be on overseeing the batch record review, change controls, deviations, CAPAs, and other aspects of QA operations associated with batch release.
The ideal candidate will have a strong background in quality assurance and regulatory compliance, with experience working with CMO/CDMO partners.
- Ensure quality and regulatory compliance throughout the different manufacturing stages.
- Develop and implement quality procedures to ensure compliance with regulations and industry standards.
- Collaborate with cross-functional teams to ensure quality and regulatory compliance.
- Review and approve records/documents including validation protocols and reports, transfer documents, change controls, deviations, CAPAs, product specifications, technical reports, stability protocols, product complaints, and temperature excursion related documentation.
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Regulatory Compliance Coordinator
1 week ago
Bothell, Washington, United States Omni Inclusive Full timeOmni Inclusive is seeking a detail-oriented and organized Regulatory Compliance Coordinator to support the cGMP Document Control operations for our Bothell site. The successful candidate will be responsible for managing an electronic document system, reviewing and approving document change requests, and troubleshooting documents to ensure they are in an...
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Bothell, Washington, United States Mbanq Full timeAbout the Role:We are seeking a seasoned strategic leader to helm our compliance team as the Head of BSA/AML and Compliance. In this pivotal role, you will report directly to executive leadership and oversee the entire compliance program, serving as the designated BSA/AML Officer. Your primary responsibility will be to ensure full adherence to regulations...
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Senior Manager for Regulatory Compliance
5 days ago
Bothell, Washington, United States Tbwa ChiatDay Inc Full timeAbout the RoleWe are seeking a highly skilled Senior Manager/Associate Director, Quality Assurance to join our team. This individual will oversee the batch record review, change controls, deviations, and CAPAs process. The successful candidate will work closely with Contract Manufacturing Organizations (CMOs) to ensure high-quality products.Key...
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Senior Regulatory Compliance Engineer
7 days ago
Bothell, Washington, United States Bausch Health Full timeAt Bausch Health, we are committed to delivering better health outcomes through our relentless drive. Our global diversified pharmaceutical company develops, manufactures, and markets a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, and international pharmaceuticals.We seek dedicated...
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Regulatory Compliance Officer
2 days ago
Bothell, Washington, United States Omni Inclusive Full timeGMP Compliance SpecialistWe are seeking an experienced Product Quality Associate to join our team. As a key member of our quality control department, you will be responsible for ensuring the quality of manufactured products and compliance with all applicable regulations and guidelines.Key ResponsibilitiesMaintains shop floor quality presence; disposes of...
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Regulatory Affairs Specialist
7 days ago
Bothell, Washington, United States Bausch Health Full timeWe are seeking a highly skilled individual to join our team as a Senior Regulatory Compliance Engineer at Bausch Health. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guiding our product development process.About the RoleThis role involves coordinating and tracking regulatory...
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Head of BSA/AML and Compliance
3 weeks ago
Bothell, Washington, United States Mbanq Limited Full timeAbout the Role:We are seeking an innovative and strategic leader to join our team as the Head of BSA/AML and Compliance. In this pivotal role, you will report directly to executive leadership and oversee the compliance team and serve as the designated BSA/AML Officer. You will ensure full adherence to regulations and requirements, including BSA, AML, CIP,...
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Head of BSA/AML and Compliance
3 weeks ago
Bothell, Washington, United States Reporter Newspapers Full timeAbout the Role:We are seeking an innovative and strategic leader to join our team as the Head of BSA/AML and Compliance. In this pivotal role, you will report directly to executive leadership and oversee the compliance team and serve as the designated BSA/AML Officer. You will ensure full adherence to regulations and requirements, including BSA, AML, CIP,...
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Regulatory Affairs Specialist Senior
5 days ago
Bothell, Washington, United States Bausch Health Full timeJob Overview:We are seeking a highly skilled and experienced Regulatory Affairs Specialist Senior to join our team at Bausch Health. As a key member of our regulatory affairs team, you will be responsible for ensuring our products meet regulatory requirements and standards.Key Responsibilities:Schedule and track progress on regulatory processes for Bausch...
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Head of BSA/AML and Compliance
4 weeks ago
Bothell, Washington, United States Jobleads-US Full timeAbout the Role:We are seeking an innovative and strategic leader to join our team as the Head of BSA/AML and Compliance. In this pivotal role, you will report directly to executive leadership and oversee the compliance team and serve as the designated BSA/AML Officer. You will ensure full adherence to regulations and requirements, including BSA, AML, CIP,...
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Head of BSA/AML and Compliance
3 days ago
Bothell, Washington, United States Mbanq Limited Full timeAbout the Role:We are seeking an innovative and strategic leader to join our team as the Head of BSA/AML and Compliance. In this pivotal role, you will report directly to executive leadership and oversee the compliance team and serve as the designated BSA/AML Officer. You will ensure full adherence to regulations and requirements, including BSA, AML, CIP,...
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Manager, Compliance Training
4 days ago
Bothell, Washington, United States Panasonic Full timePanasonic Compliance Training and Awareness Manager Every moment of every day, people all over the world turn to Panasonic to make their lives simpler, more enjoyable, more productive and more secure. Since our founding almost a century ago, we've been committed to improving peoples' lives and making the world a better place–one customer, one business,...
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Regulatory Compliance Lead
2 days ago
Bothell, Washington, United States Immunome Full timeCritical SkillsTo succeed in this role, the ideal candidate will have:Bachelor's/Master's degree in Chemistry, Biochemistry, Clinical Pharmacology, or related field; PhD preferred.Minimum 15 years of experience in pharmaceutical clinical quality assurance, with strong background in GCP/GLP/GVP compliance and auditing.Minimum 5 years of experience in...
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Compliance Manager
7 days ago
Bothell, Washington, United States Bausch Health Full timeBausch Health is a global diversified pharmaceutical company that develops, manufactures, and markets a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, and international pharmaceuticals.We are seeking a highly skilled individual to join our team as an EMC and Safety Specialist. This role...
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HR Operations and Compliance Manager
3 weeks ago
Bothell, Washington, United States Immunome Full timeCompany Overview Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of...
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Bothell, Washington, United States Kelly Science, Engineering, Technology & Telecom Full timePLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please (1) apply and (2) email your resume directly to: Regan.Brown@KellyScientific.com.Kelly Science & Clinical is seeking a Senior Director/Director of Clinical Quality Assurance (CQA) for a direct hire position at a...
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Bothell, Washington, United States Kelly Science, Engineering, Technology & Telecom Full timePLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please (1) apply and (2) email your resume directly to: Regan.Brown@KellyScientific.com.Kelly Science & Clinical is seeking a Senior Director/Director of Clinical Quality Assurance (CQA) for a direct hire position at a...
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Regulatory Affairs Specialist
5 days ago
Bothell, Washington, United States Katalyst HealthCares and Life Sciences Full timeResponsibilities: We are seeking a Regulatory Affairs Contractor to contribute to the development and execution of effective regulatory strategies for investigational products. The successful candidate will serve as a regulatory contact within an internal matrixed team environment. Execute integrated regulatory plans that deliver against strategic...
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Senior Financial Manager
2 days ago
Bothell, Washington, United States ASP Team Full timeJob SummaryThe ASP Team is seeking a highly skilled and experienced Assistant Controller to join our finance team. This key role will involve overseeing the company's accounting operations, ensuring compliance with accounting standards and regulatory requirements.The ideal candidate will have a sharp analytical mindset, exceptional attention to detail, and...
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Bothell, Washington, United States Immunome Full timeCompany Overview Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of...