IrvineRecruiter Since 2001
the smart solution for Irvine jobs

Quality Control Manager

Company: Spectrum Pharmaceuticals, Inc.
Location: Irvine
Posted on: April 5, 2021

Job Description:

Summary: The Manager of Quality Control is responsible for designing, planning, implementing, and evaluating a quality Control function which support analytical development and regulatory approval of products. This role requires extensive interaction with Pharmaceutical Operations, Quality Assurance, Quality Operations, Program and CMC project management, Regulatory Affairs, and CMOs. Responsibilities: --- Develop, implement, maintain and continually assess a quality control function and a quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements, including but not limited to, the following tasks: o Plan and coordinate all the analytical R&D and quality control activities. o Establish robust analytical development strategies. o Generate release and stability specifications for raw materials, drug substances and drug products. o Manage method development and method validation activities for drug substances, intermediates and finished drug products. o Review stability study design, monitoring, reporting and data trend-analysis. o Perform clinical material evaluation and COA generation. o Manage method transfer activities to contract manufacturing organizations/testing laboratories. o Write/review/approve, methods, protocols, validation reports etc. o Write/review/approve deviations and investigations at contract manufacturing organizations/testing laboratories. o Establishing and maintaining a document control system for QC procedures, work instructions and forms. o Ownership of test record review and COA creation. o Contribute to Annual Product Reviews. o Prepare and review analytical sections of CMC for regulatory submissions and annual reports o Implementing, performing and overseeing internal quality auditing of QC function (including applicable vendors or subcontractors), customer quality audit response, and other QC related quality management system activities. --- Implement a continuous improvement plan for growing and maturing the quality control function and the quality management system, including the following tasks: o Performing periodic internal quality control system reviews and audits o Designing, developing, implementing and enforcing best practices, processes, guidelines, systems, and technology to support and enhance the quality control function and the quality management system. --- Maintain current knowledge base of regulations, corporate policies and standards to ensure that the quality control function and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices.--- Support strategic planning by timely communicating Quality deliverables, constraints, risks and options, and collaborating with Technical Development, Program management, Clinical, Commercial, Supply Chain, and internal and external Manufacturing teams.--- Identify 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. Required Skills, Education and Experience: --- Bachelor's Degree is required (Chemistry, Biological sciences, Engineering or related degree); advanced degree is a plus.--- Minimum of 6 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.--- Ideally a minimum of 3 years of experience in leading Analytical Development/Quality Control function, preferably at the Manager level.--- Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders.--- Management skills to grow and manage a high performing Quality organization.--- Demonstrated skills in project management and working with vendors and contractors--- Background in FDA, ISO, EMA, GMP and ICH requirements ideally for ATMPs.--- Experience with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.--- Excellent interpersonal skills, organizational skills, written and oral communication skills--- Ability 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 deliverables.--- Energetic, 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 Travel: --- Position is in the United States (Irvine, CA or Cambridge, MA).--- Position may require up to 20% travel (or) occasional local travel. Spectrum 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.

Keywords: Spectrum Pharmaceuticals, Inc., Irvine , Quality Control Manager, Executive , Irvine, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Licensed Health Insurance Agent - Cutting Edge Lead Management Platform
Description: Assurance, a Prudential company, is hiring Under 65 Health Insurance Sales Agents in your city. If you're already a Licensed Insurance Agent have a Residential Insurance License, we want to hear from (more...)
Company: ASSURANCE Independent Agents
Location: Yucaipa
Posted on: 04/17/2021

Finance Manager - Automotive
Description: Job Description br Company Overview : Bob Stall Chevrolet, a family owned and operated Chevrolet auto dealer where commitment, enthusiasm, and performance are recognized and rewarded We are committed (more...)
Company: Bob Stall Chevrolet
Location: La Mesa
Posted on: 04/17/2021

Finance Manager - Automotive
Description: Job DescriptionCompany Overview: Bob Stall Chevrolet, a family owned and operated Chevrolet auto dealer where commitment, enthusiasm, and performance are recognized and rewarded We are committed to providing (more...)
Company: Bob Stall Chevrolet
Location: La Mesa
Posted on: 04/17/2021


Licensed Health Insurance Agent - Cutting Edge Lead Management Platform
Description: Assurance, a Prudential company, is hiring Under 65 Health Insurance Sales Agents in your city. If you're already a Licensed Insurance Agent have a Residential Insurance License, we want to hear from (more...)
Company: ASSURANCE Independent Agents
Location: Diamond Bar
Posted on: 04/17/2021

Salon Manager - Twin Peaks Plaza
Description: Salon Manager br br Got shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, (more...)
Company: Great Clips
Location: Santee
Posted on: 04/17/2021

Salon Manager - Old Ranch Town Center
Description: Salon Manager br br Got shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, (more...)
Company: Great Clips
Location: San Gabriel
Posted on: 04/17/2021

Sales Manager Jobs: Hiring Immediately! Full Time / Part Time - $12-$22/Hr
Description: Find your next job here Will
Company: Retail Jobs
Location: Glendora
Posted on: 04/17/2021

Product Manager
Description: Title- Product Manager Location- Onsite after Covid Duration- 12 Months Contract-Hire We can't sponsor candidates at this time and offer W2 or 1099 or Corp-Corp for citizens and s only Job Description- (more...)
Company: Launch Infotech
Location: Cypress
Posted on: 04/17/2021

Licensed Health Insurance Agent - Cutting Edge Lead Management Platform
Description: Assurance, a Prudential company, is hiring Under 65 Health Insurance Sales Agents in your city. If you're already a Licensed Insurance Agent have a Residential Insurance License, we want to hear from (more...)
Company: ASSURANCE Independent Agents
Location: Placentia
Posted on: 04/17/2021

ERP Project Manager
Description: Our direct current client is seeking a Project Manager for on-going D365 implementation roll out. Client is seeking someone with a solid track record for implementation experience with ERP systems, preferably (more...)
Company: Atrilogy Solutions Group, Inc.
Location: Cypress
Posted on: 04/17/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Irvine RSS job feeds