Social network you want to login/join with:
Head of Quality Assurance & Quality Control - Gosselies (BELGIUM) or Watertown, MA (US), Charleroi
col-narrow-left
Client:
iTeos Therapeutics
Location:
Job Category:
Other
-
EU work permit required:
Yes
col-narrow-right
Job Reference:
62fb42e24f54
Job Views:
1
Posted:
26.04.2025
Expiry Date:
10.06.2025
col-wide
Job Description:
ROLE:
The Head of Quality is the functional head of quality for the company, overseeing quality assurance and quality control teams, 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. The candidate should be able to manage quality and compliance in a growing organization.
MAIN RESPONSIBILITIES
1. Develop and implement the organizational structure, responsibilities, procedures, and processes to support company Quality Systems that meet business needs, including all applicable cGxP requirements.
2. Develop and execute the quality strategy across the organization, fostering a quality-focused culture through collaboration, training, metrics, and risk-based thinking.
3. Design, implement, and maintain (GxP) QA and QC programs and the compliance infrastructure, including SOP systems, training programs, and conducting internal and external audits.
4. Lead and manage inspections by regulatory agencies such as the FDA, and coordinate with external auditors to build trust in company quality systems.
5. Negotiate quality agreements and serve as the primary contact for quality-related contractual matters.
6. Collaborate with external suppliers, including CDMOs, CROs, and labs, to ensure consistent quality and compliance.
7. Develop and oversee quality systems to ensure product reliability, quality, efficacy, and compliance with SOPs and regulations.
8. Manage the compliance auditing program (cGMP and cGCP) to meet regulatory requirements.
9. Develop and monitor the Quality and Compliance budget.
10. Analyze and report on business metrics and quality highlights.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
1. Bachelor’s degree in science or a related field; an advanced degree is strongly preferred.
2. At least 10 years of experience in the pharmaceutical or biotechnology industry in quality or compliance roles, with experience in both sectors as a plus.
3. Minimum of 2 years’ experience as a head of a quality department.
4. Experience in building Quality Organizations and Systems, especially in late-stage clinical development.
5. Strong GxP knowledge relevant to the pharmaceutical industry.
6. Hands-on experience with implementing and managing Quality/Compliance systems and infrastructure.
7. Proven ability to develop and maintain successful relationships with regulatory agencies.
OFFER
1. A stimulating position within a high-potential, innovative biotech company.
2. The opportunity to work in a science-driven, dynamic, respectful, and professional environment.
3. Engagement in scientific and business growth, leveraging your skills and knowledge.
4. An employment contract with an attractive salary package aligned with responsibilities and experience.
#J-18808-Ljbffr