Job Description

CDC Global Solutions are delighted to partner with a growing CDMO on the hunt for a Quality Assurance Manager to join our team.

The Manager of Quality Assurance is responsible for planning, managing, and tracking quality documentation, and having quality oversight of the operation of our clients Quality Management System. This role serves as the system owner for quality tools and technologies and develops processes to ensure that quality operations are following applicable cGXP requirements, in a fast-paced environment. This individual collaborates with cross-functional teams (RA, Operations, IT, MST, etc.) to bring excellence in quality oversight and operational execution all products.

Requirements

· Support the organization to apply relevant quality standards and establish appropriate quality assurance processes to ensure compliance to those standards. Evaluate relevant changes to industry standards and practices to improve the organization's quality assurance systems.

· Develop and deliver internal training on quality assurance requirements, processes, and procedures. Partner with Operations to mentor and train staff to perform activities in accordance with the established quality assurance systems.

· Evaluate internal controls, communications, risk management and maintenance of documentation, such as Standard Operating Procedures (SOPs), to assess compliance with internal and external safety, quality, and regulatory standards.

· Provide support in the management of controlled documents to include writing, formatting, uploading, maintenance, and document changes, while also maintaining physical and archived documents using industry standard document control, change control practices and information technology systems. Assist with determining requirements for records retention, storage and disposal for business activities governed by the quality assurance systems.

· Work with internal departments/business units to identify nonconformities and support developing appropriate remedies and corrective actions. Additionally, identify risks and support departments in developing preventive actions.

· Lead cross-functional teams to evaluate process effectiveness and develop and implement process improvement.

· Prepare, maintain, analyze, and present metrics related to quality assurance activities for management review. Support management in evaluating organizational performance against quality goals and assist in developing performance improvement plans. Assist with the implementation of any resultant action items.

· Advise internal customers to support achieving organizational quality goals and objectives while ensuring compliance to organizational SOPs.

· Responsible for the review and disposition of starting materials, packing materials, bulk and finished products for use or release as appropriate.

· Responsible for review of all associated quality operations documentation needed to support disposition including CAPA, Change Controls, Deviations and Batch Records.

· Support supplier/vendor qualification audit and inspection management.

· Support any customer/vendor compliance audit/inspections as required.

· Ensure Phlow is prepared for all compliance inspections and support the on-site inspections as required.

· Contribute to the review of regulatory authority submission documents, and ensure the submissions are complete and comply with applicable regulatory requirements.

· Manage all licensing requirements in compliance with FDA and state requirements.

· Provide operational support as required for internal audits, FDA audits and FDA CGMP/GLP inspections.

Experience & Qualifications

· 10+ years of relevant experience in GxP, Quality Operations positions in a Biotech or Pharmaceutical industry

· Understanding of GxP Regulations and Regulatory requirements required for pharmaceutical productions, Active Pharmaceutical Ingredients.

· Understanding of quality systems including document management, CAPA, deviation, Change Control, and training.

· Must be proficient in MS SharePoint, MS Office 360 (MS Word, MS Excel, MS PowerPoint), Adobe Acrobat Pro.

· Experience developing business processes, Standard Operating Procedures, and Work Instructions preferred.

· Ability to travel to support supplier/vendor relationships and audit programs.

Education & Certifications

· Bachelor's degree in related Life Sciences discipline.

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