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Quality Assurance Manager

Company: Fraser Dove International
Location: Idanha
Posted on: February 19, 2021

Job Description:

Preclinical/ Clinical Quality Assurance Manager, BiopharmaceuticalsDo you have significant direct Quality Assurance (QA) experience in a biologics organisation?Would you like to manage all quality aspects of projects and ensure they comply with cGMP requirements?Are you located in Oregon, US, or are you willing to relocate?Fraser Dove International is working exclusively with an established biotechnology organisation specialising in pioneering cell therapies and new medicines. Operating worldwide, they are dedicated to becoming the world's leading pharma healthcare organisation.Our client is seeking a proactive leader to provide Quality and Compliance oversight..Discover more about our Quality Assurance Manager opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.Your objectives:As the Quality Assurance Manager, you will be measured against the following objectives:1) Overseeing all activities specific to Quality Assurance.2) Working cross-collaboratively and working on the production including development, pre-clinical and clinical activities in a CRO/CDMO environment. 3) Responsible for building, maintaining and sustaining phase appropriate key quality functions for Early Phase pharmaceutical production. What you will do:As the Quality Assurance Manager, your duties and responsibilities will include:* Exhibits technical depth in organizational management, cGMP quality systems,cGMP regulations and FDA, EU and ICH guidelines with practical implications and applications for an early phase clinical setting.* Ensure compliance and escalate issues to the quality management and other Site leadership that could pose any compliance risks to the site.* Collaborating with internal QA management and team members to ensure alignment with current site Standard Operating Procedures.* Able to develop and implement new phase appropriate cGMP systems (policy, procedures, work instructions etc.) to support early phase clinical offering.* Proven track record of successful interaction with regulatory agencies, internal and external auditing groups, and preparation of all required correspondence.* Collaborate with clinical cGMP facilities, processing equipment, laboratory testing, manufacturing, and understanding of the technical, regulatory, development and commercial aspects of pharmaceutical products* Develop and train staff in key quality systems and regulatory guidelines* Ensures R&D, product development and clinical procedures, equipment, facilities, people adequately meet regulatory requirements and are audit-ready* Provides guidance to the QA (Quality Assurance) team in the development, implementation and management of quality systems* Approves Certificate of Compliance and steady flow of QA approval for early phase products* Works with internal and external stakeholders, agencies, and partners on quality and compliance issues* Advises management on potential issues, and ensuring the implementation of the appropriate actionsWhat you will bring:These are the skills and experience you will need to succeed as the Quality Assurance Manager:* Team orientated with an exemplary ability to foster strong and long-lasting relationships.* Exceptional ability to work both independently and collaborate with others.* Ability to multi-task and shift priorities quickly while working under time constraints. Strong work ethic and determination to succeed.* Pharmaceutical/Biotechnology or related FDA regulated industry experience is required* Quality Assurance Management Experience preferred* Experience with a CRO /CDMO organization or closely interacting with a CRO/CDMO preferred* Excellent written and oral communication to include accurate and legible documentation skills.* Substantial GMP related experience in biologics or related industry with significant QA experience.* Bachelor's degree in life sciences required.What you will get:These are the perks and benefits that will complement your generous base salary:* 15% bonus.* Full relocation package.* 401kGot what it takes?To apply for the Quality Assurance Manager, click the 'Apply' button below or contact the Executive Search Consultant - Kaitlin Francis - on +44 (0)203 355 7050.Please Note:-- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.-- If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.-- We use the information in your application to support your job search, contact you with relevant opportunities and to improve our services. For more information on how we process your personal data, please view our Privacy Policy available on our website:******Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.

Keywords: Fraser Dove International, Salem , Quality Assurance Manager, Executive , Idanha, Oregon

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