Job Sr Quality Specialist, Supplier Quality (Auditor)Dendreon Pharmaceuticals • Seal Beach, CA, US
[error_messages.no_longer_accepting]
Job Sr Quality Specialist, Supplier Quality (Auditor)
Dendreon Pharmaceuticals • Seal Beach, CA, US
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Work closely with Sourcing / Procurement and Operations to ensure and manage the Quality of Supplier Goods (Raw Materials) produced by GMP suppliers, Contract Manufacturing Organizations (CMOs) and Service Providers Ensure appropriate quality agreements, standards and specifications are established and maintained with Suppliers and Service Providers in accordance with local / Federal regulations and established Quality Agreements Provide and implement solutions to Supplier and CMO issues that arise which could impact compliance to applicable regulations and Dendreon Quality Systems (including escalation to Leadership) Support and manage the planning and maintenance of annual audit program schedule, including coordinating audits as assigned. Lead, perform, and report audits to address qualification, routine, or suspected critical issues at CMOs, CTOs, vendors, suppliers, and clinical sites, ensuring vendors have quality and production systems that meet applicable regulatory, GxP requirements, and Company SOPs Write and issue audit reports in accordance with Company SOPs, templates, and timelines ensuring clear communication of audit findings to the Quality and cross functional team members Assess auditee's capabilities, technology, data integrity practices, and regulatory compliance practices and recommend necessary changes to ensure adherence to standards when non-compliance is identified Issue Supplier Corrective actions and other supplier notifications for critical findings, follow-up with vendors on the implementation of corrective actions Evaluate vendor's responses, track deliverables, and follow up on actions to closure (i.e., Corrective and Preventive Actions (CAPAs), Effectiveness Checks (ECs)) to ensure timely completion, effectiveness, and quality Optimize new and existing SOPs to maintain and improve quality standards Support supplier quality management activities to be in a state of continued compliance An experienced Quality Auditor with significant GMP experience within Supplier Quality, Quality Engineering, Auditing, and supplier relationship management A leader and problem solver who works with abstract ideas or situations across functional areas of the business internally and externally to resolve challenging Supplier issues Maintain and build effective relationships with key internal stakeholders (Site Quality, Procurement, and Operations) with regards to supplier quality Provide GMP Suppliers and Service Provider criticality classification including : Risk Assessments, Risk mitigation planning, and monitoring Assess and evaluate supplier changes from a quality perspective Maintain and Manage Supplier external audit schedule and for cause audits Perform routine onsite audits / assessments at suppliers and CMO facilities Author and maintain up to date Supplier and Service Provider Quality Agreements Report Supplier Critical Quality Metrics to Management Bachelor's degree in science / technical field (e.g., biochemistry, bioengineering, clinical research, etc.), or equivalent combined education and experience; Master's degree a plus At least 8 years of experience in a quality / compliance-based role with relevant audit management / execution and inspection readiness experience Extensive experience in GxP auditing covering GMP, GVP, and GLP functions; GCP experience is a plus. A minimum of 5 years of experience as a lead auditor. Extensive knowledge and application of ALCOA+ standard, GxP, and global guidelines Current and strong working knowledge, interpretation, and implementation of United States FDA Regulations, ICH Guidelines, and other local government regulatory requirements governing biopharmaceutical research Ability to interpret and apply regulations, regulatory guidance, and identify and recommend compliance changes as appropriate Highly diplomatic and tactful individual with exceptional critical reasoning skills Well-organized and detail oriented professional with excellent verbal and written communication skills Self-motivated with the ability to function independently and within a team in a fast-paced environment Flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen events Ability to follow up on multiple tasks simultaneously Air and overnight travel will be required 30-50% for this position ASQ / ISO auditing experience a plus ASQ Certified Auditor is a plus Knowledge of MasterControl Quality Management systems is a plus Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 20 lbs and lift up to 50 lbs.
Senior Specialist in Supplier Quality
Dendreon is making the battle against cancer personal. Our flagship product PROVENGE (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.
If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.
Core Values :
- Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer.
- Act with Integrity. Be honest, transparent, and committed to doing what's right in every situation.
- Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
- Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
- Drive Results. Be accountable and execute we win together when everyone performs.
Job Summary : (On-site in Seal Beach, CA) The Senior Specialist in Supplier Quality is responsible for ensuring that Dendreon's GMP suppliers, including Contract Manufacturers (CMOs), component suppliers, and service providers, comply with local and federal regulations as well as Dendreon's internal quality standards and specifications. This role is essential in maintaining a compliant and reliable supply chain while upholding the highest quality and regulatory standards.
Responsibilities :
Requires minimal instructions on day-to-day work and new assignments. Perform other quality related tasks or initiatives, as assigned.
Scope :
Qualifications :
Working Conditions and Physical Requirements :
[job_alerts.create_a_job]
Supplier Quality Specialist • Seal Beach, CA, US
[internal_linking.related_jobs]
Specialist Series - All Levels.A reasonable estimate for this position is $53,100-$188,200.Specialist Series - Represented Fiscal Year.
Thursday, Aug 7, 2025 at 11 : 59pm (Pacific Time).Applications ...[show_more]
Initially Santa Fe Springs, CA; relocating to Carson, CA (On-Site) Department : Quality Reports To : Quality Manager Employment Type : Full-Time, Exempt About Us Woojin IS America, Inc.WISA), headquar...[show_more]
S State College, Fullerton, CA, 92831, US.Remote Work Schedule Availability?.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's abilit...[show_more]
Are you enthusiastic, highly motivated, and have a strong work ethic? If yes, come join our team! At Cathay Bank - we strive to provide a caring culture that supports your aspirations and success....[show_more]
Join Element's Santa Fe Springs laboratory, an FDA-registered, ISO / IEC 17025-accredited facility specializing in pharmaceutical testing, trace-metal analysis (ICP-MS), extractables and leachables s...[show_more]
Now Hiring : Certified Payroll Specialist (Onsite – Santa Ana, CA).Are you an experienced payroll professional with a strong background in certified payroll processing? We’re looking for a.This is a...[show_more] City of Industry, CA, 91744, US.Remote Work Schedule Availability?.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's ability to lawfu...[show_more] 
Ensure Quality from Batch to Box : Lead QA at a Growing Food Manufacturer!.This Jobot Job is hosted by : Ryan Weingardt.Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us...[show_more]
With more than 120 operations and approximately 20,000 employees worldwide, Precision Castparts Corp.In addition, we are the leading producer of airfoil castings for the industrial gas turbine mark...[show_more]
UniUni is a Canadian last-mile e-commerce logistics company and one of the fastest-growing in North America.By integrating advanced technology with efficient delivery solutions, UniUni enables busi...[show_more]
The Senior Quality Assurance Engineer (Aerospace) is responsible for leading projects and managing cross-functional activities which assure the success of the Quality Management System (QMS).This r...[show_more]
Job Description Primary Responsibilities Implements Company and regulatory quality standards for product manufacturing.Performs, records, and evaluates chemical and physical tests necessary to cont...[show_more] S State College, Fullerton, CA, 92831, US.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's ability to lawfully obtain access to such...[show_more] S State College, Fullerton, CA, 92831, US.Remote Work Schedule Availability?.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's abilit...[show_more] 
This is a hands-on leadership role where youll guide the Quality team ensure compliance with industry standards and collaborate across departments to deliver world-class products.AS9100 & NADCA...[show_more]
Location : 1831 Carnegie Ave, Santa Ana, CA 92705 (Onsite).Estimated hours per week (Example : 40 hours or part time) : 40.
Performs product inspections at different stages of the manufacturing proces...[show_more] Vaco is partnering with a client seeking an experienced.This role plays a key part in ensuring accurate, compliant, and timely payroll processing in a fast-paced, multi-state environment.The ideal ...[show_more] This Jobot Job is hosted by : Ray Bahl.Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary : $90,000 - $115,000 per year.Founded nearly two decades ago ...[show_more]
Specialist Series
University of California - Irvine • Orange, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Supervisor
Woojin ISA • Santa Fe Springs, CA, US
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_30]
Quality Inspector III - First Shift
Howmet • Fullerton, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Loan Servicing Quality Control Specialist
Cathay Bank - Headquarters • Rosemead, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Quoting Specialist (On-Site)
Element • Santa Fe Springs, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Certified Payroll Specialist
Vaco by Highspring • Santa Ana, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Tech III, Quality Specialist
Howmet • City of Industry, CA, United States
[job_card.full_time] +1
[last_updated.last_updated_1_day] • [promoted]
Quality Manager
Jobot • Montebello, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Specialist
Precision Castparts • Paramount, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
KA Quality Control Specialist
UniUni • Brea, California, United States, 92821
[job_card.full_time]
[last_updated.last_updated_variable_days]
Sr. Quality Assurance Engineer (Aerospace)
Element Materials Technology • Huntington Beach, California, USA
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Control Specialist - 3rd Shift $1,500 Sign-On Bonus
Davis Wire • Irwindale, California, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Engineer III
Howmet • Fullerton, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Engineer II
Howmet • Fullerton, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Manager
PCC Talent Acquisition Portal • Santa Ana, California, USA
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Inspector
Objectwin Technology Inc. • Santa Ana, California, United States
[job_card.part_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_30]
Senior Payroll Specialist
Vaco by Highspring • Cypress, CA, US
[job_card.permanent]
[last_updated.last_updated_30] • [promoted]
QA Manager - SQF Practitioner
Jobot • Irwindale, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]