Quality Assurance Director
based in Houston, TX / (or) New Orleans, LA
Quality Assurance Director
(based in Houston (Taxes) or New Orleans (Louisiana), US)
The goal of this role is to design, develop, and implement Quality processes and projects to define, standardize, and harmonize quality assurance practices within Audubon (AUD) operations, and in line with AUD organizational policies, international standards and regulations, and industry guidelines. Ensures overall quality control of AUD business and operations processes, material handling, and services in line with regulatory requirements and industry expectations. Ensure all external regulatory frameworks are complied with within prudent risk and reasonable cost parameters.
- Implement harmonized and standardize Quality system and processes across all AUD geographies. Design, communicate and promote Quality vision and goals.
- Develop governing Quality system (QMS/eQMS), documents, and Standard Operating Procedures (SOPs) in conjunction with stakeholders of associated functions.
- Implement Corrective and Preventive Action (CAPA) system and other corrective Quality measures to mitigate internal errors and client queries.
- Lead Quality function in supporting successful business processes by directly overseeing or collaborating with stakeholders to oversee: regulatory compliance, quality improvement, quality risk management, internal audits, vendor/site audits, validation processes/protocols, corrective/preventive actions, records management and document control, complaint management, and quality data management across subject areas.
- Implementation, periodic review and reporting of internal Quality KPI measures fit to global and localized operations.
- Lead AUD top management representative during internal and external audits.
- Implement vendor-qualification process for partner sites and service providers.
- Review existing agreements and Quality performance of partner sites, biosample providers, laboratory and logistics vendors and collaborate cross-functionally to develop action plans to ensure trackable and measurable outcomes for each partnership.
- Periodic review of company Quality documents and SOPs to ensure up-to-date compliance with EU/USA and other country-specific regulations where AUD operates.
- Review and standardization/harmonization of current operations processes in each country/region to ensure compliance with overarching company QMS, governing documents, and SOPs.
- Review electronic storage and archiving of project-specific documentation for alignment with all applicable regulatory compliance requirements globally.
- Work with Ops Optimization to streamline processes when inefficiencies or error-risks are detected.
- Collaborate with other AUD functional leaders to drive risk mitigation, proactive action and continuous improvement.
- Design, recruit, develop, and retain a skilled global Quality team supporting AUD needs.
- Exhibits strong communication skills, critical thinking, problem-solving, and leadership skills.
- 3-5+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
- QA/QC focused certification or advanced degree is a large plus.
- Demonstrative deep knowledge and experience in Quality Assurance in a highly regulated biotech environment.
- Prior people management experience.
- Demonstrates substantial knowledge of industry best practices and trends.
- Is comfortable interacting with regulatory agencies as needed and possesses the ability to represent the company in public forums.
- Demonstrates acumen in resolving challenging Quality situations.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Proficient with Microsoft Office Suite, Google Workspace or related software.
The company offers:
- Full-time position in a fast growing business of biotechnology
- Excellent professional and career opportunities
- Open-minded executive management
- Friendly and supportive team
- Intellectually stimulating training from the best providers in the biobanking field
- Fully paid vacation and sick leave
- Medical insurance
- Opportunity to combine work from the office and from home
Qualified candidates interested in this position should send their resume via email to Natalia Sobetska-Koloda, HR Generalist ([email protected])