Director of Quality Assurance
Director of Quality Assurance
Ascend Advanced Therapies
Alachua, FL
See who Ascend Advanced Therapies has hired for this role
Location: Alachua, Florida, USA (On-site role)
Seeking a seasoned and strategic Director of Quality Assurance to lead the QA organization and work with internal and client teams to establish a quality strategy and implement and manage a PQS that meets all applicable global quality requirements at the Alachua site.
Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies. Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulatory knowledge and prioritize the quality and potency of manufacturing high-class products.
Our goal is to inspire the next generation of experts and breakthrough start-ups in the gene and cell therapy field. With a startup mindset and a track record of rapid growth, we aim to exceed boundaries and achieve continued success. Join us to pursue your passion and make a difference in the industry where there are no limits to what we can achieve.
Requirements
- Provide strategic leadership and direction to the entire QA organization including Quality systems, Quality Operations and Validation.
- Oversee the development, implementation and maintenance of robust quality systems and procedures in accordance with cGMP and relevant regulatory guidelines including Ascend corporate requirements.
- Responsibility for quality decisions affecting the Alachua site.
- Leading interactions with customers.
- Participate in internal/external audits, ensuring timely and effective corrective actions.
- Establish quality KPIs and track them.
- Lead/facilitate the Quality management reviews.
- Leading Critical and Major Change Controls, Deviations and CAPA investigations and evaluating their potential impact on Customers, Ascend Operations, facilities, analytical results, and product quality.
- Ensuring GMP-compliant validation and qualifications.
- Lead the development and execution of a comprehensive training program for the QA team. Providing training of PQS procedures to Ascend staff.
- Reviewing documents, test results, and summary reports for compliance with Ascend and regulatory requirements.
- Acting as the QA SME on new and emerging regulations.
- Point of contact for Quality topics for Customers and Qualified Person(s)
- Manage the QA budget and ensure efficient resource allocation.
- Ensuring a safe work environment.
- Foster a culture of continuous improvement within the QA organization.
- 15 years of experience in biologics manufacturing with 10 years in a leadership role within Quality Assurance. CGT experience a plus.
- Bachelor's Degree in Life Sciences, Engineering, or related field. Master's degree preferred.
- In-depth knowledge of cGMP regulations, ICH guidelines, and other relevant quality standards.
- Knowledge of AAV manufacturing process and clean room environment a plus.
- Ability to make decisions and manage own and team priorities in alignment with department and site objectives.
- Ability to present PQS, Ascend strategy and supporting data in a clear and understandable way during audits.
- Demonstrated ability to think logically and evaluate complex situations to arrive at the true root cause.
- Experience in using Root Cause Analysis Tools, Risk Management processes, Technical Writing and Microsoft Office applications.
- Strong Team player, with focus on safety, quality, and timelines.
- Ability to work in a fast-paced environment and to prioritise own and teamwork.
- Ability to build strong relationships and collaborate effectively across departments.
- Excellent Written & Oral Communication skills.
- Annual bonus
- 401k
- Medical, Dental, Vision, Life, Short-Term and Long-Term Disability, AD&D, and additional insurances.
- 20 days PTO
- 5 days Sick leave
- 6 weeks Parental Leave
Aim Higher - Our motto and values.
- Quality by integrity - We set high standards, putting quality and evidence first to seek the best solutions.
- Adaptability is in our DNA - We are forward-thinking problem solvers, driven by the developing science and to deliver the best medicines.
- Serving patients by serving our partners - We can depend on each other, and on the organisation, to deliver goals and services.
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Seniority level
Director -
Employment type
Full-time -
Job function
Quality Assurance -
Industries
Non-profit Organizations and Primary and Secondary Education
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