Sr Manager, Quality Systems and Compliance at Dendreon Pharmaceuticals, LLC in Seal Beach, California

Posted in Other 2 days ago.





Job Description:

Dendreon Pharmaceuticals, LLC

Location: US-CA-Seal Beach
Job ID: 2021-2167
Category: Quality Assurance


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.

Job Summary:

Provide leadership to the manufacturing site quality systems and compliance team. The manager also has responsibility for all people aspects, such as coaching, talent development, recruitment and performance management. This position will perform activities required for site inspection readiness and an efficient quality system.

Responsibilities

  • Manages two or more functions and/or departments within Quality Assurance including the management and ownership of manufacturing site:
  • Quality system activities inclusive of change control, capa, training, document control, biological process deviation reports and validation/computer system validation.
  • Compliance activities inclusive of Management Review, Annual Product Review, Internal Audits and regulatory inspection preparation.
  • Perform/Ensure satisfactory investigational and problem-solving skills are in use.
  • Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
  • Able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas.
  • Strong authorship and ability to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.
  • Use of acceptable, applicable analytical mindset.
  • Able to recognize quality risks and develop contingency plans.
  • Able to assess, establish and implement new quality processes. Able to author resulting procedures and tools.
  • Able to recognize patterns in reported data and communicate strategic solutions to stakeholders' cross-functionally.
  • Host inspections for regulatory/internal/corporate audits.
  • Keeps abreast of industry trends and best practices and leads critical to quality continuous improvement projects/initiatives
  • Solid knowledge of sterile products manufacturing processes and testing. Knowledge of aseptic manufacturing processes a plus.
  • Ensures work is in compliance with required regulatory standards, conforms to company policies and SOPs. Recommends changes to policies and establishes procedures that affect immediate organization(s).
  • Leads and as applicable provides timely quality support to stakeholders and SMEs on key projects and initiatives.
  • Skilled in planning and organizing, building relationships, innovation management and resource allocation.
  • Ability to make independent and objective decisions with cross-functional teams and partners.
  • Able to provide strong leadership and drive results through people.
  • Oversees department budget and demonstrate sound financial stewardship, management and control.
  • Ensure compliance with safety, health, environmental and cGMP and other applicable regulations.

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.
  • Acts as advisor to subordinate(s) and business partners to meet schedules and/or resolve technical problems.
  • Develops and administers schedules, performance requirements; will have budget responsibilities.


Qualifications

  • BS or MS in Life Sciences or other relevant scientific discipline with 10+ year's industry experience within the pharmaceutical or biotechnology industry along with previous supervisory and/or leadership experience.
  • In depth knowledge of current regulatory requirements in support of cGMP manufacturing operations (i.e., FDA and ICH guidelines).
  • Thorough knowledge of and competence in core quality processes - including change control, deviations/OOS, CAPA management, investigations, APR.
  • Experience in aseptic operations preferred.
  • Experience with regulatory inspections (e.g. FDA)
  • Proven leader and team player, who is dynamic, motivated and excited to work with a wide range of internal experts and functions.
  • Excellent communications and decision-making skills, leading with initiative and ambition, and a proven ability to deliver excellence.
  • Collaborate and foster internal teamwork with other cross-functional areas and sites.
  • Proven ability to influence and effectively achieve results in sensitive situations.
  • Maintains the highest standards of ethical behavior.
  • Drives results through team assigned orientated and performance driven


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 (2°C - 8°C); (-20°C); (-75°C); (-196°C) 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


Dendreon is an Equal Employment Opportunity F/M/Disability/Vet/Sexual Orientation/Gender Identity / Affirmative Action employer and provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures. If you have any difficulty using our online system and you need an accommodation due to a disability, you may use the alternative email address below to contact us about your interest in employment at careers@dendreon.com, or you can send your resume to Angalisa.savala@dendreon.com or you can call us at +1-562-252-7500.PI138886628