Description
Reporting to: VP Quality 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.
What you’ll bring:
- 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.
Benefits
- 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
Company Values:
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.
To start your journey with us at Ascend, kindly submit your resume and a cover letter showcasing your qualifications and interest in the role. We value diversity and oppose discrimination. While we eagerly await all applications, we'll only reach out to selected candidates for interviews. Please note that successful candidates must be legally authorized to work in the United States and will undergo E-verify authentication. Thank you for considering joining our team as we shape the future together!
