Description
Title:
Quality Assurance Validation Manager
Location:
Alachua, Florida
Reporting to:
Director of Quality Assurance
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.
Mission
As the Quality Assurance Validation Manager, you will play a pivotal role in ensuring the highest standards of quality and compliance. You will review and oversee Commissioning, Qualification, and Validation (CQV) and Computer Software Validation (CSV) documentation for Quality Control (QC) and Manufacturing (Mfg.) equipment, Computerized Systems, Utilities, and Facilities using GAMP 5 methodology. Your expertise in regulated environments will ensure our operations maintain rigorous validation standards, meeting both quality and business objectives efficiently.
Key Responsibilities
- Provide quality oversight for validation activities across manufacturing, facilities, utilities, and QC equipment.
- Define and align methodologies and deliverables for commissioning, equipment IOQPQ, process/analytical validation, material evaluation, utilities, facilities commissioning, qualification, computer system validation, and risk management.
- Review and approve all validation-related documents including Master Plans, Functional Requirements Specifications, User Requirement Specifications, Installation and Operational Qualifications, Validation Protocols, scripts, and reports.
- Author site master files and lead deviation investigations related to equipment and facilities.
- Continually evaluate and improve internal processes to enhance efficiency and compliance with regulatory standards.
- Provide training and guidance on CQV topics to foster a quality-focused culture.
- Act as the subject matter expert in CQV and process owner for the Change Control system.
- Partner with the Validation team to define strategies and implement process improvements.
- Ensure compliance with Data Integrity (DI) and 21 CFR Part 11 Assessments.
- Support pre- and post-execution approval of protocols for new constructions and expansions.
- Monitor quality performance through key performance indicators and present data in meetings.
- Assist in regulatory inspections and client audits, ensuring compliance with cGMP regulations.
Requirements
- Bachelor’s degree in any discipline, engineering preferred.
- Extensive experience reviewing and approving commissioning and qualification documentation.
- Background in gene therapy, rare diseases, and neuromuscular diseases is a plus.
- Minimum of 8+ years of industry experience, with 10+ years preferred, focusing on Quality Assurance Validation.
- Familiarity with GAMP 5, process control systems, ERP systems, and MES.
- Strong knowledge of risk-based approaches in biotech manufacturing environments.
- Comprehensive understanding of FDA, EMA, local regulations, and industry best practices.
- Proven ability to work in a fast-paced, high-growth environment with strong analytical and communication skills.
- Excellent attention to detail, project and time management skills, and proficiency in MS Office products and validation software.
Benefits
- 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 organization, 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!
