Sr. Quality Specialist - Supplier Quality

Job ID 2020-1780
Job Locations
US-CA-Seal Beach
Category
Supplier QA

Overview

Who we are.

Dendreon is making the battle against cancer personal. Founded on the belief that the immune system holds the key to the future of cancer care, Dendreon is committed to the delivery of treatments that harness the power of the body’s immune system to attack cancer cells.

If you are looking to positively impact the lives of patients, we want you to join our team. Headquartered in Seal Beach, California, and with sizable locations in Union City (Greater Atlanta), Georgia and Seattle, Washington, as well as countrywide Commercial and Medical Science Liaisons teams, we have a diverse offering of exciting opportunities.

What we do.

 

Vision – Pioneering the future of immunotherapy.

Mission – Making the battle against cancer personal through immunotherapy treatments that extend lives.

 

How we do it.

 

The Dendreon Way.  We are a purpose-driven, value-based culture. At Dendreon, we…..

  • Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer.
  • Elevate Our People. The strength of our company lies in the success of our team.
  • Drive Results. Be accountable and execute – we win when everyone performs.
  • Foster Innovation. Building a culture of creativity, and pushing past boundaries.
  • Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.

 

Are you ready?

 

Our high-performing organization challenges, develops, and rewards employees interested in pushing past typical career limitations. If you are passionate about helping patients and looking for a unique career opportunity, view our open positions to apply or refer a friend today.

 

Job Summary: To ensure Dendreon GMP Suppliers including: Contract Manufacturers, Protein Synthesis, Sterile filling, Components and Service Providers are compliant with Local and Federal regulations including Dendreon specifications and standard

Responsibilities

Responsibilities:


 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).
 Execute Quality System external audits of CMO’s, Raw Material Suppliers, and Service
Providers. Review responses and associated CAPA to assure proper mitigation.
 Interface, as necessary, with external auditors including officials from the US Food and Drug Administration and other international regulatory authorities as required.
 Strategize with key departments stakeholders to ensure timely completion of all supplier
quality objectives and milestones.
 Lead projects as assigned by the Director of Supplier Quality.
Scope:
 An experienced Quality Professional with significant GMP experience within Supplier
Quality, Quality Engineering, Auditing, and supplier relationships 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 stake holders (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.

Qualifications

Job Requirements:


 Bachelor’s degree in a scientific discipline or equivalent.
 5-10 years of related experience in cGMP/FDA regulated industry.
 Strong and demonstrated knowledge of FDA regulations and guidance for Good
Manufacturing Practice in a pharmaceutical environment.
 Strong verbal and written communication skills.
 Proficient in MS Office applications.
 Well-developed team and collaboration skills. Air and overnight travel will be required 30-50% for this position.
 Experience in project management a plus.
 21CFR and ASQ/ISO auditing experience a plus.
 ASQ Certified Quality Engineer a plus.
 Ability to gown aseptically for work in Clean Room environments.


Working Conditions and Physical Requirements:


 Extensive use of laboratory equipment, chemicals and biological materials.
 May be required to work alternate shifts.
 Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC) areas.
 Must have the ability to work around laboratories, manufacturing areas and equipment, and
regularly lift 10 – 20 lbs and lift up to 50 lbs.


Dendreon is an equal employment and affirmative action employer F/M/Disability/Vet/Sexual Orientation/Gender Identity.
The preceding job description has been designated to indicate the general nature and level of work performed by employees
within this classification. Additional and incidental duties related to the primary duties may be required for company
business needs from time to time.

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