ABOUT THE POSITION

This 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 a Product Quality Assurance Manager, you will play a critical role in accomplishing this mission and in staging Aurion Biotech’s novel cell therapy treatment for successful launch in the United States.
We are seeking an experienced Product Quality Assurance Manager to work collaboratively with internal and external stakeholders to drive execution of project milestones. Primary responsibilities include oversight of the internal Quality Management Review program, tracking of Quality Department projects to ensure completion according to project milestones, and being a liaison between Aurion Quality and our external CDMO partners. This position reports to the Product Quality Lead.

QUALIFICATIONS AND EDUCATION

To 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.

• 2-3 years’ experience in Quality Assurance, Quality Control or other related function with a Master of Science in Biochemistry, Chemistry or other relevant scientific disciplines preferred
• 5+ years’ experience in Quality Assurance, Quality Control or other related function with a Bachelor of Science in Biochemistry, Chemistry or other relevant scientific disciplines preferred
• Experience with Quality Management Review requirements as defined by ICH Q(10) required
• Experience with tech transfer and late-stage development preferred
• Excellent working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FA, ICH) required
• 1-2 years’ experience working with program management software (Smartsheet, MS Project, or equivalent) required. PMP Certification preferred, but not required
• Experience working with internal cross-functional teams and external partners preferred

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Demonstrated proficiency with managing project timelines and ensuring deliverables are met, adapting to rapid change as needed
• Ability to work cross-functionally with excellent verbal communication and collaboration skills
• Strong written and oral communication skills with ability to summarize scientific data in a logical, organized, clear and persuasive manner
• Quality mindset with demonstrated ability to address compliance gaps
• Advanced proficiency in use of MS Office and Project Management software
• Ability to work effectively both independently and with other team members

To 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.

• 2-3 years’ experience in Quality Assurance, Quality Control or other related function with a Master of Science in Biochemistry, Chemistry or other relevant scientific disciplines preferred
• 5+ years’ experience in Quality Assurance, Quality Control or other related function with a Bachelor of Science in Biochemistry, Chemistry or other relevant scientific disciplines preferred
• Experience with Quality Management Review requirements as defined by ICH Q(10) required
• Experience with tech transfer and late-stage development preferred
• Excellent working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FA, ICH) required
• 1-2 years’ experience working with program management software (Smartsheet, MS Project, or equivalent) required. PMP Certification preferred, but not required
• Experience working with internal cross-functional teams and external partners preferre