Manager, Supplier Quality

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Job description

Overview:
Who we are.

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 Beal, 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.

Your Role: Manages the operations in one or more functional areas within Supplier Quality including planning of all Dendreon Raw Material Release, Resource Management, External Suppliers, Contract Laboratory oversight, and new Laboratory supplier qualification.

Responsibilities:
Your Work:

Responsible for Management of the following across all Dendreon Sites:

Supplier Quality raw material primary contact and process owner

Raw materials inspection and release approver

Raw materials non-conformance and supplier investigations

Qualification and approver of new suppliers and raw materials

Supplier Quality owner of activities with external laboratories contracted to conduct development or sample testing of raw materials

Ensures raw materials conform to company standards and satisfy GMP regulations

Reviews and approves change controls, methods, procedures for inspecting, testing, sampling plans and evaluating the quality of raw materials and contract laboratories.

Investigates non-conforming material defects and contract laboratory OOS results, provides feedback to suppliers, and approves corrective actions to be taken ensuring conformity with quality specifications.

Provides technical insight to other departments as part of cross-functional project teams.

Monitor GMP Supplier Quality systems to ensure compliance with documented policies

Ability to train, develop and mentor direct reports and effectively manage the performance of individuals in all Dendreon locations with regards to raw material

Contributes to the development of department budget and monitors expenditures

Ability to perform independent onsite audits of contact laboratories and CMO's

Receives assignments in the form of objectives and establishes goals. Provides leadership to direct staff members to achieve goals in accordance with established policies. Assignments are reviewed and measured based on meeting objectives and schedules. Establishes and implements changes to policies affecting Supplier Quality Raw Materials across all Dendreon sites, monitors these changes post implementation for effectivness.

Provides leadership with regards to problems of diverse scope where analysis of the situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as leader to staff to meet schedules and/or resolve technical problems. Develops and administers schedules and performance requirements.

Frequently interacts with direct reports, customers and/or functional peer group managers. Interacts with senior management, interactions normally involve matters between functional areas, and external suppliers.

Job Requirements: Manages activities related to monthly QPI, defect tracking, costs, and on time raw material release. Is responsible for a functional area and has subordinate employees, and manages highly skilled professional employees.

Qualifications:
Education Requirements:

Bachelor's degree in a scientific discipline or equivalent.

Job Requirements:

Typically 8 years related experience in cGMP/FDA regulated industry.

Typically 4 years leadership experience.

Extensive knowledge of cGMP/ICH/FDA/USP/ASTM regulations and standards.

Extensive knowledge of lean six sigma and/or statistical techniques

Extensive experience in leading complex investigations, implementing CAPAs, initiating change controls and providing recommendations to Sr. Management

Ability to think critically and creatively to identify and solve problems

Familiarity with technology transfer, BLA

Proficient in MS Office applications.

Certified lead auditor for external laboratories and CMO's

Working Conditions and Physical Requirements:

Ability to sit or stand for extended periods of time

Intermittent walking to gain access to work areas

Finger dexterity sufficient to use a computer and to complete paperwork activities

Vision sufficient to use a computer, to read written materials and to complete paperwork activities;

Hearing sufficient to communicate with individuals by telephone and in person

Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) 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.

May be required to work alternate shifts

Ability to gown aseptically for work in Clean Room environments

Job performed in a lab, office, or utility (noisy) environment

Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.

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