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.
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.
Raise the Bar: Harness continuous improvement, foster innovation and elevate our people.
Drive Results: Be accountable and execute – we win when everyone performs.

Primed for Growth - Contract/Partner Manufacturing Business Unit.

Dendreon has been working in the cellular immunotherapy space for over 10 years and brings all the experiences that comes with developing a complex manufacturing process from clinical development through to consistent commercial production. Dendreon is unmatched in its patient logistics/operational functions, manufacturing excellence in

cellular therapies and commercial sales team for cellular immunotherapies. Given this expertise, we plan to leverage these strengths to grow Dendreon's pipeline of products initially through contract manufacturing for partners and then patient operations and eventually commercial sales.

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.

Summary.

The Quality Supervisor, Quality Systems/Compliance supports site Quality Systems & Compliance (QSC). This role manages and leads a wide variety of QA activities that align with policies, processes, procedures, and controls to ensure compliance with applicable regulatory requirements. Primary responsibilities for this role are:

Lead day-to-day activities of the Document Management and Validation Programs within Quality Systems & Compliance.
Work with internal and external project teams on the development of standardized documents and templates.
Ensure an organized process flow for easy access to all documents in a timely manner.
Oversee periodic review of all documents.
Manage the review, release, and retention process for documentation relating to all current good manufacturing practice (cGMP), Standard Operating Procedures (SOP) and FDA Regulations/Guidelines.
Work with internal and external project teams on validation/qualification projects, process and equipment validation, and Quality System initiatives to ensure on time deliverables are met.
Review and approve Validation plans, User Requirement Specifications (URS), Validation protocols and summary reports associated with the commissioning and validation of equipment, process validation, and method validations.
Provide QA oversight for GMP validation activities and apply risk-based methodology to validation efforts.
Provide QA assessment and approval of GMP validated systems related procedures, Nonconformances, CAPAs, and Change Controls with no supervision depending on complexity of system.
Provide framework for generation of the URS, IQ, OQ, and PQ documentation, as needed.
Update site VMP.
Monitor, participate, and oversee compliance activities for Quality Council meetings, Annual Management Review, Internal Audits, Inspection Readiness, and equipment validation, as needed.
Evaluate the impact of nonconformances and CAPAs to product quality and provide detailed product impact assessment in collaboration with Subject Matter Experts (SMEs) and Quality Partners.
Lead and assist with problem-solving and Root Cause Analysis.
Organize and present data and Quality metrics to Senior Management.
Assist with the Annual Product Review.
Author and review documents (i.e. Standard Operating Procedures; Reports).
Provide Change Control risk assessment and impact assessments.
Participate in Internal Audits and FDA/Regulatory Agency inspections as SME.
Set performance standards and encourages employee engagement through delegation, continuous feedback, goal setting, and performance development planning.
Coach, mentor, develop, and provide career development, training opportunities, and succession planning for direct reports.
Oversee new employee onboarding.
Primary driver for continuous improvement.
Serve as the Lead in the absence of the Manager.
Provide support for any other duties assigned.

Responsibilities

Demonstrate strong interpersonal effectiveness skills.
Demonstrate analytical and systematic problem-solving skills.
Display excellent customer service skills
Demonstrate competent communication to effectively:
Authentically lead and strategically influence direct reports
Interact with Regulatory Authorities
Provide knowledge/technology transfer for applicable quality systems
Communicate to management and the group with clarity, brevity, and accuracy
Ensure work is in compliance with required regulatory standards and conforms to company policies and Standard Operating Procedures (SOPs).
Perform changes to policies and establishes procedures that affect immediate organization(s).
Provide timely quality support to stakeholders.
Demonstrate exceptional skilled planning and organizing, and relationship building.
Collaborate and lead discussions and projects with cross-functional teams and partners.
Frequently interact with direct reports, Quality partners, and functional peer groups at various management levels.
Drive process and program improvement changes.
Ensure compliance with safety, health, environmental and cGMP and other applicable regulations.
Establish positive relationships and interfacing with internal, multi-functional departments.
Notify Senior Management regarding quality issues as required by site procedures for escalation and prepares reports as requested.

Scope.

Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
Follows policies and procedures in selecting approaches and techniques to obtaining solutions.
Exercises judgment within defined procedures and practices to determine appropriate action.
Works independently with no instruction on routine work, little instruction on new assignments.
May be required to work alternate shifts.
Some travel may be required.

Qualifications

Education and Professional Experience.

BS in Applied Sciences or other relevant scientific discipline
7+ years in a cGMP regulated environment with related experience within the biopharmaceutical or biotechnology industry preferred.
3+ years direct/indirect supervisory experience. Performance management experience required.
Advanced knowledge of current regulatory requirements in support of cGMP manufacturing operations (i.e., FDA and ICH guidelines).
Strong working knowledge in validation methodology (IQ,OQ,PQ).
Experience in knowledge of sterile products aseptic manufacturing processes and testing preferred.
ASQ certification preferred.

Skills.

Experience managing a team of exempt/non-exempt employees
Exceptional attention to detail
High energy, motivated self-starter
Excellent Interpersonal skills (i.e. communication) to interface effectively with all levels of colleagues in a team environment, and with vendors, contractors and external customers, as applicable
Ability to use professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways
Solve problems of diverse scope in which analysis of data requires evaluation of identifiable factors
Excellent and demonstrated organizational skills related to priorities and workload that have proven results in the ability to be self-directed while managing multiple projects
Ability to collaborate and foster internal teamwork with other cross-functional areas and sites
Ability to work and make decisions independently and have the flexibility to adapt to changing priorities
Ability to lead Quality Projects, as needed
Demonstrate and maintain the highest standards of ethical behavior
Ability to drive results through independent assignments or team assigned orientated tasks and responsibilities
Ability to network, share best practices and further develop skill level
Ability to manage multiple priorities and tasks in a fast pace, dynamic environment
Work well under pressure with an ability to meet tight deadlines
Ability to exercise good judgment.
Demonstrated knowledge of cGMP
Ability to use computer programs

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
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 – 25 lbs. and occasionally up to 50 lbs
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.

Average Compensation: $126,000

How Much Do Dendreon Employees Make?

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