Quality Assurance Director is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a Quality Assurance Director identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, Quality Assurance Director typically requires a bachelor's degree. Typically reports to a director. The Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Join our dynamic team at Beacon Therapeutics (USA) Inc. as a Full Time Associate Director in Quality Assurance Operations! This is an exciting opportunity to play a key role in ensuring the quality and compliance of our biotech products. As we continue to grow and innovate in the industry, you will have the chance to lead and shape our QA operations, making a real impact on the company's success.
Working onsite in Alachua, you will collaborate with a diverse team of professionals who share our core values and uphold a culture of professionalism and respect. If you are looking for a challenging and rewarding position with a competitive salary, this role is perfect for you. Join us in making remarkable happen at Beacon Therapeutics (USA) Inc. You will be offered great benefits such as Medical, Dental, Vision, 401(k), Life Insurance, Health Savings Account, Flexible Spending Account, Competitive Salary, Paid Time Off, and Employee Discounts. Apply now!
If you're passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. We're a diverse, multi-national team of talented people all working together at our sites in the US and the UK, or as a remote contributor. Everyone here, whatever their role or location, plays a genuine part in bringing our treatments to patients. Everyone has a voice, and every contribution makes a difference.
As the Associate Director in Quality Assurance Operations at Beacon Therapeutics (USA) Inc., you will be responsible for overseeing Contract Development and Manufacturing Organizations (CDMOs), managing batch release processes, and leading quality system-related activities. Your strategic oversight in these key areas will be pivotal in ensuring the quality and compliance of our biotech products. By effectively managing CDMOs and guiding batch release procedures, you will play a critical role in maintaining our high standards and upholding our commitment to excellence in the industry.
Your expertise and leadership in quality assurance operations will drive our continued success and growth in Alachua.
To excel as the Associate Director in Quality Assurance Operations at Beacon Therapeutics (USA) Inc., candidates must possess a strong skill set including proficiency in CDMO management, batch release processes, and quality system expertise. A thorough understanding of regulations and CGT manufacturing and release processes is essential for success in this role. Critical thinking and problem-solving skills are crucial for effectively addressing quality assurance challenges, while clear and concise communication is key for collaborating with cross-functional teams.
The ability to navigate electronic systems, train others on cGMPs, and multitask in a fast-paced environment are also important skills needed to thrive in this position.
Knowledge and skills required for the position are:
If you think this job aligns with your requirements, then submitting an application is simple. Good luck!
NOTE: Agencies and Recruiters need not contact. Unsolicited resumes will not be considered.
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