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Lead Quality Assurance Architect
2 months ago
Job Title:
Lead Quality Assurance Architect
Job Overview
The Lead Quality Assurance Architect is responsible for supervising quality assurance and validation processes for innovative products and projects. This position demands exceptional technical and instructional capabilities in quality management systems. You will establish project timelines and lead a small team of Quality Engineers to ensure critical milestones are met.
As the Subject Matter Expert (SME) and Quality approver, you will manage GxP documentation throughout the project lifecycle while ensuring adherence to both domestic and international regulatory standards and guidelines.
Your duties will include reviewing and approving Change Control/Management Documents, acting as a key resource during regulatory audits, resolving product complaints and safety concerns, and conducting quality audits.
Additional responsibilities encompass developing sampling strategies, delivering quality training, participating in Material Review Board meetings, and supporting regulatory submissions.
This role emphasizes the review of regulatory documentation, making informed QA decisions, and enhancing quality assurance processes.Essential Skills
• Expertise in pharmaceutical quality management systems
• Proficient in quality oversight (Stability, Change Control, Internal Auditing, CAPA, Exceptions, Out of Specification Investigations, Customer Complaints, Document Control, Annual Product Reviews, Equipment Qualification, Process Validation)
• Familiarity with statistical analysis tools
• Competent in Microsoft Office Suite
• Experience with project management timelines, including MS Project
Interpersonal Skills
• Innovative thinking
• Ability to navigate ambiguous situations based on FDA guidelines
• Mentorship capabilities
• Skill in assessing strengths and delegating responsibilities
• Leadership in critical projects
• Strategic planning and anticipation of future requirements
• Capacity for risk-based decision-making
• Solutions-focused approach
Job Type
This is a Contract-to-Hire position with a duration of 6 Month(s).
Work Environment
The position reports directly to the Senior Director of Site Quality.
The standard work schedule is Monday - Friday, with some flexibility required to meet project deadlines or accommodate specific phases of the process.
You may also need to respond to inquiries from team members during off-hours as necessary as the project progresses.About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions.
We assist visionary companies in advancing their engineering and science initiatives by providing access to specialized experts who drive scale, innovation, and speed to market.
With a network of nearly 30,000 consultants and over 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many Fortune 500 companies.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are integral to the equity and success of our workforce.
Our DE&I initiatives include:
• Hiring diverse talent
• Fostering an inclusive environment through ongoing self-reflection
• Building a culture of care, engagement, and recognition with measurable outcomes
• Ensuring growth opportunities for all employees
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.
