Associate Director of Quality Assurance

The Associate Director of Quality Assurance is a pivotal leader in cultivating a culture of quality, operational efficiency, and excellence. This role ensures that quality and compliance are seamlessly integrated into daily operations and aligned with the organization's long-term Quality strategy. The position provides strategic direction and oversight for Quality Assurance functions, driving end-to-end harmonization of quality processes, including risk management, GMP core management, and adherence to global regulatory requirements. Success in this role depends on fostering and leveraging strong partnerships with key stakeholders to execute strategies that align with and support the organization’s business priorities.

Qualifications:

Minimum of a bachelor’s degree, preferably in a scientific discipline.

A minimum of 8 years of experience in compliance, quality, and CMO management with a focus on regulatory documentation and lifecycle management within the pharmaceutical or biotechnology industry is a must, including 5 years of experience in management/leadership roles.

8+ years in a QA management role.

Minimum of 10 years of GMP experience.

10-12 years of QA related experience required.

General knowledge of aseptic manufacturing processes.

·       Broad knowledge of FDA and international regulations related to GMPs and Biopharma.

·       Experience organizing and managing work responsibilities while working independently with minimal oversight.

·       Time and project management skills with the ability to multi-task and meet deadlines.

·       Excellent verbal and written communication skills.

·       Excellent interpersonal and customer service skills. 

·       Excellent organizational skills and attention to detail.

·       Strong analytical and problem-solving skills.

·       Ability to prioritize tasks and to delegate them when appropriate.

Deep knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase programs.

·       Experience with regulatory inspections by the FDA and EU authorities.

·       Experience with drug substances and drug products is desired.

·       Knowledge of regulatory requirements across development stages and post-approval is essential.

·       Expert working knowledge of full drug development process and knowledge of FDA and ICH regulatory requirements.

·       Strong strategic and analytical abilities, diplomacy, and negotiation skills.

·       The ability to collaboratively influence across multiple functions and motivate others to accomplish company objectives.

·       Ability to work flexibly within tight timelines and with strong project management skills.

·       Self-motivated and detail oriented with sound judgement and innovative thinking to deal with challenges/opportunities.