Your Path to Endless Opportunities

If you’re looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you’re enthusiastic, creative, with a passion for cutting-edge research and development, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs, as well as for our partners across major therapeutic areas.

Vice President, Quality Assurance

Summary of Position

Anavex Life Sciences Corp. is seeking a talented and highly motivated Vice President of Quality Assurance (VP, QA) to join our team. This position will have full responsibility for all Quality Assurance activities and provide critical Quality leadership to all relevant functional areas. This position will have the unique opportunity to help grow and shape the quality team, quality systems and processes, supporting both current operations and company initiatives that improve the quality and content of all clinical programs to deliver our portfolio.

 

The VP, QA is responsible for ensuring compliance with all applicable GxP (GCP and GMP) regulations. This includes Quality oversight of all clinical activities at clinical sites and supporting contract research organizations (CROs), global health authority requirements ensuing patient safety, strategic planning for continuous improvement efforts, reporting/escalation of critical quality issues, site qualifications/audits, regulatory agency inspections and responses thereto, risk mitigation, and ensuring a compliant culture of quality throughout Anavex via effective leadership, consistent with Anavex’s core values.


Key Responsibilities 

  • Management and direct oversight of all GCP and GMP activities related to FDA and ROW regulations for clinical programs and chemistry, manufacturing and control (CMC) activities at and on behalf of Anavex, including all GxP activities at clinical sites, CMOs, CROs and raw material suppliers.

  • Lead efforts to develop, implement and provide oversight of Anavex’s Quality Management Systems (QMS), addressing Quality Agreements, SOPs, CAPAs, CSRs, stats output, etc.

  • Perform and direct audits of external suppliers and internal systems.

  • Host audits with regulatory authorities.

  • Development and implementation of strategies to ensure compliance with applicable regulatory requirements.

  • Implement strategic audit plans for all compounds across all stages of development.

  • Report significant investigation/deviation issues and system deficiencies to senior management, as appropriate, and facilitate corrective actions.

  • Develop a comprehensive inspection readiness program and represent the company during regulatory inspections.

  • Provide strategic organizational direction to assure responses to quality-related regulatory queries are timely and complete.

  • Support quality activities during due diligence. 

  • Advise executive management on developments in regulations and standards related to GxP quality that may impact company strategies and programs.

Requirements

  • Minimum of a Bachelor’s degree in Biology, Chemistry, or related fields; advanced degree preferred.

  • A minimum of 15 years in the pharmaceutical/biotechnology sector, with 7-10 years in a leadership role within the QA function, including both GCP and GMP Quality for Phase 1-3 clinical trials. Commercial stage product experience a plus.

  • Expert knowledge of FDA and EMA GMP, GCP, and regulatory requirements, ICH guidelines and industry standards.

  • Experience in developing, implementing and leading company-wide quality management system.

  • Experience conducting GCP/GMP audits

  • Experience interacting with FDA, EMA and other global health authorities

  • Experience with building a GCP/GMP culture in a start-up pharmaceutical/biotechnology company is preferred.

  • Experience with the successful management of inspection readiness programs and FDA and global regulatory inspections.

Your Path to Unique Opportunities
If you’re looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you’re enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, pain, and various types of cancer. Further information is available at www.anavex.com.


EOE/M/F/V/SO Anavex Life Sciences Corp. is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status. Visit anavex.com/eeo-policy-statement to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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