Director of Compliance

Title: Director of Compliance

Reporting to: VP Quality

Location: Alachua, Florida, USA (On-site or hybrid role)

The Alachua manufacturing site is part of Ascend Advanced Therapeutics, a gene therapy CDMO.  Ascend is a specialist AAV development partner working to support the next-generation of life-science innovators in bringing gene therapy products to patients.  Come join our team and let’s aim higher and develop the next wave of accessible life-saving therapies together.

The Role:

As the head of the new GMP quality audit management function, reporting directly to VP, Quality this position will be responsible for strategic oversight and management of Ascend’s self-inspection and external GMP audit programs. This role serves as a subject matter expert in effectively planning, executing/managing internal and external GMP audits/self- inspections and is familiar with US and EU and other international GxP regulations/requirements. This role is expected to collaborate closely across all functions at Ascend and lead the Quality Audit function.

Requirements

• Lead and deliver on external and internal audit initiatives.
• Optimize the existing internal self-inspection/internal and external GMP audit program.
• Identify and maintain GxP risk registry as it pertains to internal and external processes subjects to audit program and communicate effectively with stakeholders to mitigate the risks appropriately.
• Develop measurement tools (KPIs) and apply them to measure and evaluate audit program performance using standard metrics and report during Quality Management Review.
• Host regulatory inspections and client audits on site.
• Evaluate existing processes and systems for continuous improvement and lead the effort through procedural updates, guidance, and training to impart knowledge to internal stakeholders on industry best practices.
• Interpret new/changing regulations and determine their applicability to Ascend’s QMS.  Deliver training on any such regulations to key stakeholders.
• Collaborate with Senior Leadership team to define the escalation process and communicate accordingly.

Requirements:

• BS/BA degree in a scientific or allied health field; advanced degree preferred.
• Minimum of 12+ years of hands-on experience as a Lead Auditor/Sr. Quality role with demonstrated ability and acumen to lead/build efficient teams as needed in biologics or pharma industry.  CGT experience a plus.
• Solid knowledge of FDA, EU, MHRA GxP regulations, guidelines, and industry standards.
• Proven track record of leading audit related efforts for GMP related activities to fulfill regulatory requirements.
• Ability to communicate clearly and concisely.
• Experience in using Root cause Analysis tools, Risk Management processes, technical writing, and Microsoft office applications.
• Strong Team player, with focus on compliance and timelines.
• Ability to work in a fast-paced environment and to prioritize work.

Benefits

• Annual bonus  
• 401k matching up to 3%, 50% on the next 2% 
• 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 
• More to come as we grow!

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 Form I-9 verification. Thank you for considering joining our team as we shape the future together!