Manager of Quality Assurance (Quality Operations)
Company: Spectrum Pharmaceuticals
Location: Irvine
Posted on: January 12, 2021
|
|
Job Description:
Tracking Code 690-470 Job Description Summary:The Manager of
Quality Operations is responsible for providing quality oversight
to all manufacturing operations in support of clinical development
and commercial products, including but not limited to, Drug
substance, Process Intermediates, and Drug Product(s). This role
requires interaction with Clinical Operations, Pharmaceutical
Operations, Program and CMC project management, Regulatory Affairs,
Supply Chain, and CMOs.Responsibilities:Provide quality oversight
to all manufacturing operations in support of clinical development
and commercial products. Ensure all manufacturing activities in
support of Drug substance, Process Intermediates, and Drug
Product(s), are conducted in accordance with internal company
standards and in compliance with quality agreements.Administering
policies and standard operating procedures (SOPs) relating to the
Quality Operations function. Identify opportunities for
improvements.Real time batch record review and resolution of
associated deviations prior to product disposition.Manage
Deviations and Change Controls at the CMO sites.Assist with
delivering quality training for the team.Provide all required
documentation in support of the Annual Product ReviewsReview of CMC
sections for regulatory submissions to ensure accuracy and
completeness. Participate in activities to assist with regulatory
submissions, control strategy development and CMC strategy.Quality
review of Technology transfer protocols and final reports.Help with
the Preparation and assist during regulatory inspections at the CMO
sites.Using incident and Corrective and Preventive Action
(---CAPA---) activities and processes to drive quality improvements
and respond to process and service issues.Implement short-term and
long-term strategies, goals, and objectives related to the Quality
Operations function and the quality management systemReview and
recommend appropriate corrective action to ensure consistency with
the Quality Operations function and the quality management
systemRepresent Quality Operations function in connection with
internal or external audits, inspections, , and provide
quality-related information related to (but not limited to) client
assessments, RFPs, contracts and other documentationMaintain
current knowledge base of regulations, corporate policies and
standards to ensure that the Quality Operations function remain in
compliance with applicable regulatory and corporate
standards/requirements and current with industry trends and best
practicesIdentify risks and assumptions in plans, anticipate
problems and plan for contingencies. Remove obstacles to move work
forward and/or to get efforts back on track.Skills, Education and
Experience:Bachelor's Degree is required (Biological sciences,
Engineering or related degree); advanced degree is a plusMinimum of
5 years related experience in the
Pharmaceutical/Biopharmaceutical/Biotechnology industry.Ideally a
minimum of 3 years of experience in leading a Quality function,
preferably at the manager/supervisor level. Proven ability to
effectively develop, communicate, and gain support for execution
plans with team members from other functions.Management skills to
grow and manage a high performing Quality organization.Desirable to
have skills in project management and working with vendors and
contractorsBackground in FDA, ISO, EMA, GMP and ICH requirements
ideally for ATMPs.Familiar with regulatory submissions, ideally for
products which were ultimately approved for commercial
distribution, and regulatory inspections.Interpersonal skills,
organizational skills, written and oral communication skillsAbility
to work in a fast paced and dynamic environment that will require
management of several competing priorities while driving all
projects forward and meeting program/project deliverablesEnergetic,
flexible, collaborative and proactive; a leader who can positively
and productively impact initiatives.Availability:Must be available
to work in the evenings and weekends, as required.Position Location
and/or Territory and TravelPosition is located in Irvine, CA or
Cambridge, MAPosition may require up to 20 % travel and occasional
local travelSpectrum Pharmaceuticals is an equal opportunity
employer. We evaluate qualified applicants without regard to race,
color. Religion, sex, national origin, disability, veteran status,
and other protected characteristics.Job Location Irvine, CA or
Cambridge, MA, United States Position Type Full-Time/Regular
Keywords: Spectrum Pharmaceuticals, Irvine , Manager of Quality Assurance (Quality Operations), Executive , Irvine, California
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Executive JobsSr. Manager, Organization Design Description: br Part of your life. Part of tomorrow. br br We make life easier, safer and greener - with technology that achieves more, consumes less and is accessible to everyone. Microelectronics from Infineon (more...) Company: Infineon Technologies Americas Corp. Location: El Segundo Posted on: 01/23/2021 Remote Tax Manager (Contract) Description: Remote Tax Manager br br Compensation: br br Senior Manager: 65 / hour and up br br Manager: 50 - 60 / hour br br Location: Remote br br Duration: 2-3 months this role would be (more...) Company: Beech Valley Solutions Location: Los Angeles Posted on: 01/23/2021 VP of Product Quality & Technical Services Description: Company is a design led pioneering mobility technology company researching, developing and producing next generation electrically powered vehicles. As the electrification revolution begins to infiltrate (more...) Company: ExecuNet Location: Manhattan Beach Posted on: 01/23/2021 QUALITY MANAGER- HYDRAULIC SYSTEMS, SANTA CLARITA Description: Position Purpose-- --The Quality Manager, Level 2 is responsible to build, lead, and improve a quality engineering organization and for the development and implementation of quality improvement strategies (more...) Company: Woodward Inc. Location: Castaic Posted on: 01/23/2021 Director of Developer Services Description: SUMMARY: Director of Developer Services is responsible for development and implementation of the strategic vision and planning of the Branch with respect to developing communities and relationships with (more...) Company: Associa Location: Foothill Ranch Posted on: 01/23/2021 Project Manager, Technology V Description: RESPONSIBILITIES:Kforce has a client in search of a Project Manager in Los Angeles, CA. Essential Duties: Manages large and/or multiple projects with significant impact on business Company: Kforce Technology Location: Los Angeles Posted on: 01/23/2021 Sr. Product Manager (REMOTE) Description: Aha is the world's 1 roadmap software. We help more than 5,000 companies build lovable products and be happy doing it. Our company is self-funded, profitable, and has been entirely remote since we started (more...) Company: Aha! Location: Los Angeles Posted on: 01/23/2021 Retail Management - LA/North and Surrounding Area Description: Store Manager --- directly influences the performance of everyone who interacts with guests and supports a solution selling environment. The Store Leader is responsible for fostering a selling culture (more...) Company: Gamestop, Inc. Location: Panorama City Posted on: 01/23/2021 Assistant Store Manager Description: JOB SUMMARYThe Spectrum Assistant Store Manager is responsible for assisting the Store Manager in building a highly successful sales, retention and customer care culture inside their store. Actively and (more...) Company: SPECTRUM Location: Lawndale Posted on: 01/23/2021 Hospitality Manager Description: Know what it's like to be in the stadium on game day Then you know what it's like to work at Buffalo Wild Wings. It's fun. It's fast-paced. We're at the top of our game - and we want to keep it that (more...) Company: Buffalo Wild Wings Location: Los Angeles Posted on: 01/23/2021 |