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Quality Assurance Manager

JOB OVERVIEW:
This role is the leader of Celltex’s Quality team, dedicated to ensuring that our Mesenchymal Stem cell products meet the highest standards of quality and reliability.

As Quality Assurance Manager, you will play a key role in providing comprehensive quality oversight and guidance throughout the end-to-end manufacturing process of cell therapy products for individual use or for clinical trials. This includes overseeing the life cycle from starting materials until Finished Goods manufacturing. Your responsibilities will encompass ensuring compliance with regulations, contributing to the development of the quality management system, and providing innovative quality input and support to Celltex.

JOB DUTIES:

• Be an expert in quality management system, ensuring activities conform with requirements.
• Be a subject matter expert on investigations, deviations, root cause analysis tools, CAPAs, change control, and complaint investigations.
• Support and participate in compliance audits, OSHA inspections, and interactions with regulatory agencies.
• Identify compliance gaps, quality issues/discrepancies, and effectively and proactively resolve them in a flexible and constructive manner.
• Manage the inspection readiness program at the site to ensure site is always inspection ready and manage the logistics of any corporate, external or Health authority inspections at the site.
• Perform risk management, monitor Quality and compliance metrics, and review/approve relevant Quality documents for compliance to clinical trial protocol, regulatory filings and product specific requirements.
• Lead department cross-functional risk assessments to ensure all angles are considered as needed.
• Perform routine QA duties to ensure GMP, plus other regulatory requirements relating to manufacture of cell therapy products including:
  • Document control system- including document issuance and retirement, and maintenance of document history files
  • Change controls
  • Corrective and preventative actions (CAPA) – Implementation and Evaluating the adequacy and effectiveness of corrective and preventive action plans
  • Deviation & out of specification (OOS) reporting
  • Complaint and recall handling
  • Calibration and maintenance coordination
  • Qualification & validation coordination
  • Internal and external audits including vendor /supplier qualification – Perform audits of manufacturing and quality control practices and procedures, including internal audits, vendor qualification audits, and audits of investigator sites.
  • Lead inspection and accreditation procedures as necessary, including leading and overseeing audit/ inspection preparation activities and remediation plans.
  • Supervise the QA Specialist on audit-related work, during final production and quality control record review, and during the release of finished products.
  • Batch record reviews prior to release.
  • Draft, review and approve Quality and GxP related documentation.
  • Training – Develop and conduct GXP and safety training courses for all staff annually, post-audits, and as necessary, and maintain staff GMP training records.
  • Develop budgets and monitor expenditures related to Quality Assurance activities and programs.
  • Review and approve validation protocols, reporting and working with the cross functional teams to establish necessary documentation.
  • Prepare, organize, track and perform QA review of FDA submissions to include: INDs, Annual Reports, Supplements.
  • Conduct weekly quality review meetings and prepare reports.

SKILLS/QUALIFICATIONS:

• Knowledge of GMP, GCP and FDA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products.
• Experience training staff and building and managing small team.
• Experience with Clean rooms and ISO14644 requirements.
• Experience with aseptic technique and Clinical manufacturing operations.
• Experience in setting up and managing robust GxP compliant Quality Management systems.
• Ablilty to write/author SOPs, and plans/reports to support clinical trial manufacturing operations.
• Demonstrable experience in planning, managing and executing vendors, raw materials, and site audits.
• Excellent organizational skills, including efficiency, punctuality, and collaboration in a team environment.
• Excellent interpersonal skills for enforcement of identified improvements.
• Knowledge of current industry trends and the ability to use the latest technologies.
• Knowledge of 21CFR P11 compliance and Annex 1 guidelines.
• Proficiency with computer skills, such as MS Office.
• Ability to think “outside the box.”

EDUCATION/EXPERIENCE:

• Possess a Bachelor’s degree in life sciences AND a minimum of 7 years of relevant experience in the biotechnology, pharmaceutical or biological sciences industry OR Master’s degree with 4 years of experience.
• Have at least 2 years of demonstrated experience in Quality Assurance operations, preferably in a management role.
• Experience working with third party contract, calibration, manufacturing, testing organizations and clinical sites.
• Exhibit proficiency in interpreting cGMP regulations and showcasing quality oversight in sterile cell and/or gene therapy operations.
• A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products.
• Demonstrate a proven track record of problem-solving and effectively managing the department.
• Cell and gene therapy experience.
• Audit experience.

REPORTS TO: Chief Executive Officer

DEPARTMENT: Quality Assurance

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Celltex Therapeutics Corporation is a U.S. Equal Opportunity Employer.