Senior Quality Systems Leader — GMP/ISO Compliance
Werfen North America
Werfen North America is seeking a Senior Quality Systems Specialist II in San Diego, California. This role involves leading major elements of the Quality Management System and compliance with GMP, FDA, and ISO regulations. The ideal candidate will have a Bachelor's degree and over 10 years of experience in the medical device industry. A strong understanding of Quality System Regulations and previous Quality Assurance experience are essential for this role. #J-18808-Ljbffr Werfen North America
- Werfenlife SA. in San Diego is seeking a Senior Quality Systems Specialist II to lead the Quality Management System in compliance with regulatory requirements. The candidate will... ...and a strong understanding of FDA and ISO regulations, the ideal candidate will contribute...QualitySenior
$120k - $150k
UNAVAILABLE is seeking a Senior QS Specialist II in San Diego,... ...planning and improvement of Quality Management Systems. This position demands extensive... ...experience in QA within GMP regulated environments, focusing on compliance with FDA and ISO standards. Candidates should...QualitySenior- Werfen is seeking a Senior Quality Systems Specialist II in San Diego, California, responsible... ...comply with regulatory standards such as GMP, FDA, and ISO. This role involves managing key... ...readiness along with supporting regulatory compliance initiatives across departments. A...QualitySenior
- ...using manual and electronic systems in accordance with established... ...retention and archival, ensuring compliance with applicable regulations.... ...personnel records within the quality system. Assign document-... ...including: 21 CFR Part 820 ISO 13485 ISO 14971 CLIA, CAP,...QualitySenior
$90k - $110k
Werfenlife SA. in San Diego, CA is seeking a Quality Systems Specialist III to support the Quality Management System and ensure compliance with GMP, FDA, and ISO standards. This temporary position will assist with key quality activities such as CAPA processes, deviation...QualitySeniorTemporary work$155.9k - $257.3k
...Responsibilities: This role must develop strategic quality programs to oversee and foster the... ...at sites; and site transfers QMS compliance : front room host for external audits and... ...including any applicable step rate pay system at the work location. Salary or hourly pay...QualitySeniorHourly payWork at officeRemote workShift work$90k - $110k
The Quality Systems Specialist III is responsible for enhancing the Quality Management System (QMS) to ensure compliance with various standards. This temporary role, based in San Diego, California... ...in Quality Assurance within a GMP regulated environment and will be expected...QualityContract workTemporary work$85.12k - $95.76k
...Pharmaceutical Services Ltd in San Diego, CA seeks a Sr. Compliance Specialist to ensure adherence to regulatory standards within... ..., contributing to a culture of compliance, and supporting Quality Management Systems. Ideal candidates will have a Bachelor’s degree and strong...QualitySenior- Ignite Human Capital is seeking a Quality Systems Engineer in San Diego, California. This role is crucial in maintaining the Quality Management System in compliance with regulatory requirements like ISO 13485 and FDA standards. The ideal candidate will have strong leadership...QualitySenior
$90k - $110k
Werfen North America is seeking a Quality Systems Specialist III in San Diego, CA to enhance the Quality Management System (QMS) and ensure compliance with applicable regulations. This temporary role involves responsibilities around CAPA processes, internal audits, and...QualitySeniorTemporary work- ...firm located in San Diego is looking for a Quality Assurance Senior Specialist to support clinical trial projects. You will ensure compliance with regulatory requirements, lead... ...candidate has over 10 years of experience in a GMP environment and possesses excellent...QualitySenior
$120k - $140k
Capricor Therapeutics is seeking a Supplier Quality Specialist/Supervisor responsible for maintaining high-quality standards in... ...comprehensive supplier quality program, managing audits, and ensuring compliance with GMP standards. The ideal candidate should have a Bachelor’s...QualitySenior- ...Computer Systems Validation Lead Oversight of facilities systems... ...of computer systems compliance. The cross-functional role will... ...Responsibilities: Serve as the Quality lead for lab and process... ...Good Manufacturing Practices (GMP) and Good Clinical Practices...QualitySeniorWork at office
- ...Senior Business Systems Analyst (ERP) Invivoscribe is an industry pioneer and global leader in precision oncology diagnostics. For... ...bioinformatics tools under ISO 13485 design... ...governance, and compliance with applicable internal controls and quality standards. Participate...QualitySeniorWork at officeWorldwide
$90k - $110k
Werfen is seeking a Quality Systems Specialist III in San Diego, California for a temporary... ...Quality Management System to ensure compliance with FDA and ISO standards. Candidates should have a Bachelor... ...in Quality Assurance within a GMP environment. The salary ranges from $...QualityTemporary work$120k - $150k
...continuous improvement of key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as they... ...Essential Functions: The Senior QS Specialist II will be expected to support...QualitySeniorWork at office- ...company is looking for a Staff Business Systems Solutions Architect to enhance customer... ...oversee technology changes and ensure high-quality experiences for users. You should have... ...technological transformations, ensuring compliance while driving innovation and operational...QualitySenior
$120k - $150k
...We are a worldwide leader in specialized diagnostics... ...to innovation and quality. We're passionate... ...Position Summary: The Senior Quality Systems (QS) Specialist II... ...) in alignment with GMP, FDA, ISO, and global... ...system processes, leads compliance improvement initiatives...QualitySeniorFull timeWork at officeWorldwideShift work- ...LifeSciences in San Diego is seeking a Manager, QA Operations to oversee the Quality Assurance department. Key responsibilities include managing daily operations to ensure compliance with ISO 13485:2016 and other regulatory standards. The ideal candidate should have a...Quality
- Kaiser Permanente in San Diego seeks a leader in behavioral health to manage clinical programs... ...role includes coaching teams, ensuring compliance with regulations, and fostering a... ...dynamic work environment dedicated to high-quality member services. #J-18808-Ljbffr Kaiser...QualitySenior
$210k - $270k
...need them most. The Senior Director, Quality Assurance & Quality Systems provides strategic... ...regulatory compliance, inspection readiness... ...the senior Quality leader and strategic advisor... ...fully aligned with FDA GMP regulations (21 CFR... ...), ICH guidelines, ISO standards, and...QualitySeniorWork at office- Irvine Company is seeking a Senior Director, Project Management, to lead the San Diego regional team in overseeing property... ...operational excellence through project efficiency, quality control, and regulatory compliance. The ideal candidate will have significant experience...QualitySenior
- ...leading consulting firm seeks an experienced Senior Computer System Validation Consultant in San Diego to provide Quality Assurance oversight for computerized systems... ...activities throughout the system lifecycle, ensuring compliance with global regulatory standards. The ideal...QualitySenior
$110k - $135k
Dynalectric-Company is seeking a Control Systems Engineer 3 in El Cajon, California. This role involves leading projects, providing technical expertise in control systems, and ensuring project quality objectives are met. Successful candidates should have over 7 years of...QualitySenior$81.95k - $122.87k
...Business Systems Analyst Senior The Enterprise Mandates Delivery team is... ...is about developing great leaders at all levels and creating... ...approaches to meet regulatory compliance with the business community... ...lowering costs, improving quality, and enhancing the member and...QualitySeniorFull timePart timeWork at officeLocal areaWork from homeHome office2 days per week$75k - $83k
PolyPeptide in San Diego, CA is seeking a Senior Quality Assurance Specialist to ensure that clinical and commercial products meet regulatory... ..., Quality Control, and Regulatory Affairs to maintain high compliance. The ideal candidate has 5-7 years of QA experience in the...QualitySeniorFull time$250k - $350k
...EisnerAmper is seeking a Senior Director of Finance Transformation and Systems who will provide... ...team of senior finance leaders. Set clear priorities... ...across teams to ensure high-quality delivery. Foster... ..., audit readiness, and compliance across finance...QualitySeniorLocal area$150k - $175k
Genalyte, Inc., a vibrant diagnostics company based in San Diego, is seeking a Manager/Staff Systems Engineer. This role involves leading cross-functional teams to ensure high-quality product development in a regulated environment. Candidates must have a Master's degree in...QualitySenior- ...Quality Assurance Compliance Specialist We are a clinical-stage biotechnology company focused on developing... ...Support the deviation and CAPA/SCAR Systems by investigating, reviewing, assessing... ...regulations, including FDA, ISO, ICH, and company policies and procedures...QualitySeniorFlexible hours
- ...Zifo North America is seeking a Senior Scientific Business Systems Analyst (Senior BSA) to support strategic... ...driven solutions, and ensuring high-quality delivery across complex R&D... ...applicable) and support remediation of compliance gaps. Project Execution & Delivery...QualitySeniorFlexible hours3 days per week
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