The Vice President of Quality Assurance is responsible for the strategic development and execution of the Company's quality assurance program, and is accountable for the execution and administration of the GXP Quality Systems to support GMP, GLP, and GCP compliance in accordance with ICH, US and EU regulations. The VP will build an internal team and relationships with external consultants/contractors, as necessary to support QA activities and responsibilities and provide leadership and guidance to the organization on global quality matters. This position requires expertise in current Good Manufacturing Processes (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) and relevant regulations. The successful candidate will drive, promote and embed a culture of ethics, integrity and continuous improvement that will focus on delivering efficiencies.
- Ensures that the Quality System meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.
- Ensures quality metrics comply with best industry standards and practices.
- Maintains an effective Quality governance and continually improve governance to meet business and compliance needs.
- Ensures overall Quality and Compliance oversight for manufacturing, supply chain, nonclinical and clinical. Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance.
- Establishes strong working relationships with external manufacturers of our products and assure alignment of our Quality Systems and requirements with these CDMOs. Ensures products manufactured at CDMOs meet company quality standards and government regulations.
- Establishes, maintains, and has oversight of internal Quality Management Systems. Continually establish and improve quality systems, initiatives, priorities, and timelines.
- Ensures appropriate quality criteria built into selection, implementation or upgrading of electronic systems used to support any GXP related activities
- Provides appropriate Quality oversight of external vendors (CMOs, CROs, etc.)
- Provides leadership and mentorship of the Quality team. Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met.
- Keeps abreast of industry developments, forthcoming regulations, guidance, best practices etc.
- Counsels, train and interpret quality requirements to ensure we and our GxP vendors maintain a state of compliance.
- Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management.
- Serve as an escalation point for corporate quality issues.
- Serves as primary contact in any audit by a regulatory authority and lead all audit communications with audit personnel from a regulatory agency. Responsible for supplier/vendor qualification audit and inspection management.
- Conducts all duties in compliance with country specific regulations, applicable SOPs, and other applicable guidelines.
- Bachelor's degree or higher in related Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered.
- 15+ years of relevant experience in GxP, QA management or QA leadership positions in a Biotech and/or Pharmaceutical industry.
- Extensive knowledge and in-depth experience of implementation of Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments for USA, EU and other global Health authorities
- Familiar with ICHQ9 principles and has demonstrated the ability to utilize Quality Risk Management principles in everyday practice.
- A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members
- Pro-active in identifying opportunities with a strong solution minded approach and flexibility to emerging challenges based on scope and growth of the organization.
- Strong collaborative, influencing and interpersonal skills with excellent verbal, written and presentation skills with the ability to deal effectively across all levels of management
- Ability to prioritize competing activities and manage resources and budget accordingly