Vice President Quality Assurance - Fairway Consulting Group (Springfield)
Fairway Consulting Group
: Executive Management
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Our client is a clinical research company. They have asked us to assist them in their search for a Vice President, Quality Assurance
Major tasks and responsibilities will include:
Leads Quality Assurance function.
Builds overarching quality strategy for the company.
Represents Quality Assurance in company project meetings to ensure adherence to regulatory and compliance requirements.
Recommends solutions to complex quality issues and works closely with senior management to resolve significant compliance trends and issues.
Develops and implements processes, procedures, and systems to perform critical activities in an efficient and effective manner.
Manages audit program against GxP standards, FDA/EMA/ICH requirements, and other regulatory standards and ensures timely resolution of any identified issues.
Implements GCP Quality Assurance programs for clinical trials execution and reporting.
Quality management of CMOs, contract test laboratories and other vendor services to ensure compliance of manufacture and testing of product.
Establishes and maintains phase appropriate GMP compliance for product manufacture, testing, and stability; ensures appropriate review and assessment of production records, in-process and release testing methods, specifications, validations, reference materials and test results.
Manages Quality Assurance relationships with GMP service providers; work with CMO QA and technical teams to assess and resolve discrepancies, and noncompliance events to ensure the quality of the product through performance of thorough investigations and risk assessments.
Reviews and edits Quality Agreements.
Provides quality input to project plans, master service agreements and statements of work.
Reviews technical and study reports, CMC sections of regulatory submissions, pharmacy manuals, investigator brochures, study protocols and reports, as requested, for compliance with established standards, and regulations.
Ensures robust planning and execution of documentation for product release.
We seek candidates with the following qualifications:
A Bachelors degree in science, pharmaceutical sciences or related field, is required. Masters degree or PhD, preferred.
A minimum 15 years of Quality Assurance experience is required.
A minimum 10 years of experience in GMP pharmaceutical development, manufacturing and testing is required.
Must have the ability to manage priorities, track progress of key projects, and provide updates to leadership.
Requires thorough knowledge of Phase 1 through Phase 3 product development. Commercial manufacturing and/or large pharma experience a plus.
Must have technical knowledge of analytical method qualification, process validation and establishing product specifications.
Experience with personalized medicines and/or gene therapy preferred
Experience with outsourced manufacturing and testing operations with solid understanding of how to onboard new CMOs capable of producing complex therapies preferred
Must have experience working in compliance with US, EU and ICH GMP requirements.
Requires experience reviewing submission documentation, and responses to regulatory inquiries and inspections.
Must have the ability to effectively communicate with teams, peers, management and external contacts.
Proven organizational and leadership skills.
If interested, please email your resume as a Word attachment to us, reference 3721. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlons list of Top 50 Healthcare & Life Sciences Search Firms.