ROLE:
Head of Quality Assurance & Quality Control
The Head of Quality is the functional head of quality for the company, overseeing quality assurance and quality control team, managing the total compliance function. The Head of Quality will be responsible for ensuring compliance with established company quality policies, practices, standard operating procedures (SOPs) and federal regulations.
iTeos seeks a quality leader who is career-driven, has strong management and mentoring skills and a depth of experience in managing complex quality systems, and is able to manage quality and compliance in a growing organization.
MAIN RESPONSIBILITIES
Responsible for developing the organizational structure, responsibilities, procedures, processes, and leading the team to support company Quality Systems that meet the needs of the business, including all applicable cGxP requirements.
1. Develops and implements the quality strategy throughout the organization. Helps create a quality focused culture through collaboration, training, metrics, and risk-based thinking.
2. Design, implement and maintain (GxP) QA and QC programs, and the compliance infrastructure. This includes the SOP system, training programs, and performing internal and external audits.
3. Lead and manage inspections by FDA, other regulatory agencies, and commercial partners.
4. Coordinate with regulatory agencies and other external auditors to build trust and confidence in company quality systems.
5. Lead quality input on contracts and serve as the primary contact for the negotiation of quality agreements.
6. Work with the company's external suppliers including contract development and manufacturing organizations (CDMOs) clinical research organizations (CROs) and contract labs to ensure consistent quality and compliance.
7. Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, cGxP regulations.
8. Oversee compliance (cGMP and cGCP) auditing program to fulfill regulatory requirements.
9. Develop, manage and monitor adherence to the overall Quality and Compliance budget.
10. Develop, analyse and report business metrics and highlights.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
11. Bachelor’s degree in science or a related field; advanced degree strongly preferred.
12. 10+ years' experience in the pharmaceutical or biotechnology industry in a quality or compliance. Having both pharmaceutical and biotechnology experience a plus.
13. 2+ years’ experience as a functional head of a quality department.
14. Experience in building a Quality Organization and Quality Systems in the context of late-stage clinical development will differentiate candidate.
15. Strong GxP knowledge in the pharmaceutical industry.
16. Hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure).
17. Proven record of developing and maintaining successful working relationships with regulatory agencies.
OFFER
18. A stimulating position within a high-potential innovative biotech company.
19. The opportunity to work in a science-driven, dynamic, respectful, and professional environment.
20. A challenging scientific and business growth in which you get to bring your knowledge and skills.
21. An employment agreement contract with an attractive salary package in line with the position responsibilities and your experience.