Director of Quality Operations - US
We are looking for a Director of Quality Operations that will be responsible for all US-based GMP Quality activities ensuring the quality of our products, compliance with applicable US regulations and timely supplies to the market.
As a member of the Quality Leadership team, you will be accountable for the performance of ARTBIO’s Quality US GMP organization providing support for the cGxP compliance, management and continuous improvement of the Quality Management System (QMS), as well as the ownership of quality indicator targets along with the oversight of all Quality inspections for CDMOs and GMP activities. While this you will be responsible for Quality Operations for our US affiliate, you will report to the Global Head of Quality and will build collaborative and strategic relationships with all of ARTBIO’s senior leadership, specifically the Technical Operations and CMC team.
- Partner with the Head of Quality to build the short and long-term Quality vision.
- Lead an efficient Quality operations organization, compliant with cGxP requirements of FDA, and the Quality Management System related to the GMP manufacturing, test, release and distribution of pharmaceuticals as well as support preclinical and clinical US activities as needed.
- Ensure the US Quality oversight over all Quality activities, including Notification to Management, Quality Alignment, Market actions, Quality Councils and others.
- Ensure the implementation and continuous improvement of the Quality Management System to ensure compliance of existing and evolving guidelines, to increase the efficiency of the quality processes and quality systems and to identify and execute corrective and preventive actions, where applicable.
- Ensure a strong deviation investigation management system is established including oversight over externals US contracted activities, that identifies and investigates quality deviations to root cause, defines appropriate CAPAs, ensures CAPA effectiveness and timely reporting in accordance to regulatory requirements in US.
- In an effort to support ARTBIO’s mission of continue improvement and growth, as phase-appropriate optimize processes, monitor KPIs, and ensure a strong deviation investigation management system is established including oversight over externals US contracted activities, that identifies and investigates quality deviations to root cause, defines appropriate CAPAs, ensures CAPA effectiveness and timely reporting in accordance to regulatory requirements in US.
- Stay abreast of industry trends and compliance requirements while managing both internal and external relationships.
Qualifications & Education
- Master’s Degree with a major or concentration in Science, Life Sciences, Engineering, Pharmacy or related.
- Experience Required: Minimum 10 years in leading pharmaceutical operations with a clear expertise in Quality with at least 3 year of US experience. A mix of experiences in Operations and Quality leadership roles is preferred including knowledge in GMP. Desirable knowledge in GCP and GLP.
- Deep knowledge of Quality Compliance, Regulatory and cGxP practices and guidelines for US including experience with FDA inspection and interactions
- Good communication and presentation skills, both written and verbal – the ability to gain executive support.
- Strong Interpersonal/Relationship Management Skills, ability to mentor, manage and develop staff as well as manage/develop suppliers.
- Strong analytical skills and conceptual thinking that drive strategic and innovative options.
- Strong business acumen and critical thinking, able to anticipate impact of decisions & initiatives.
- Capacity planning and experience in budgets and headcount management