JOB TITLE: Associate Director, Quality AssuranceLOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS or WA.
SALARY RANGE:$176,000 to $204,000ABOUT THE POSITIONThis is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of cell therapy and cornea care innovation. As Associate Director, Quality Assurance, you will play a critical role in accomplishing this mission and in staging Aurion Biotech novel cell therapy treatment for successful launch in the United States.
The Associate Director, Quality Assurance is responsible for overseeing activities performed by Contract Development and Manufacturing Organizations (CDMO) and Contract Testing Labs (CTL) to ensure compliance against procedures and regulatory submissions and federal requirements. This position will also partner cross-functionally to strengthen quality systems, manage vendor quality activities, support inspection readiness, and foster a culture of quality and continuous improvement.
KEY RESPONSIBILITIES- Serve as team lead to internal QA team members, leading QA oversight of CDMO and internal QA activities, ensuring compliance with regulatory/GMP expectations, and established Quality Agreements
- Support and maintain vendor assessment activities
- Quality management of vendors providing risk-based decision-making during manufacturing and testing activities
- Support quality performance / continuous improvement activities
- Oversee quality of third-party supplier's services (manufacturing, filling, packaging, shipping as appropriate) and maintain regular oversight via periodic monitoring, auditing, and Quality Agreement reviews
- Manage Data Verification activities to ensure data integrity and compliance with GDP
- Identify opportunities to improve quality systems and clinical-to-commercial operational processes and drive implementation to completion
- Develop, monitor, and report meaningful quality metrics and KPIs to support Quality Management Review
- Support Quality systems, including internal and external deviations and change controls
- Assess product, compliance, or operational risks and partner with cross-functional teams to develop and implement effective risk management strategies
- Review and approve controlled documents
- Other duties as assigned
QUALIFICATIONS AND EDUCATIONTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's degree Biology, Chemistry or other relevant scientific discipline preferred.
- 8-10 years of cGMP Quality Assurance experience with cell therapy, biologics, and/or small molecule programs
- 5+ years of experience in directly managing a team of direct reports within QA
- Commercial QA experience a plus
REQUIRED SKILLS AND ABILITIES - Travel required up to 35%.
- Experience with eQMS (e.g., ACE, TrackWise)
- Working knowledge of current industry practices and standards in an FDA-regulated biotechnology company
- Excellent record keeping and documentation skills
- Strong communication skills, both verbal and written, with the ability to concisely present information in cross-functional settings
- Experience working with CDMOs prefererd
- Proficient use of MS Office products
- Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all cGMP and regulatory requirements are met
- Ability to work effectively both independently and with other team members.
Salary Description
$176,000 to $204,000
