Associate Director, Quality Control
Aspect Biosystems
Quality Assurance
Vancouver, BC, Canada
Posted on Thursday, August 17, 2023
We are seeking an Associate Director of Quality Control to join Aspect’s Process Development and Manufacturing team to support the development and production of our bioprinted tissue therapeutics. In this role, you will play a key role in creating and implementing the QC strategy. You will be accountable for delivery of all QC programs, projects, and laboratory operations, ensuring staff remain on task and execution is aligned with regulatory expectations and with industry best practices. This is an exciting opportunity to collaborate closely with a talented team of tissue engineers, biomaterials experts, and biologists in optimizing our bioprinted tissue therapeutics that have the potential to revolutionize the treatment of diseases like diabetes and liver disease.
WHAT YOU’LL DO
- Develop and implement quality control strategy and roadmap.
- Establish QC laboratory’s capabilities to meet our needs.
- Lead and develop the QC team, providing clear priorities, feedback, and career development opportunities.
- Oversee all QC operations, including raw materials, in-process testing, bulk release, stability testing, microbiological testing, environmental monitoring, and stability programs.
- Coordinate activities and policies between departments.
- Manage QC department budget, timelines, and schedules.
- Provide direction to project teams, identifying and resolving issues.
- Ensure cGMP compliance and audit readiness in all areas of responsibility.
- Oversee the development and implementation of standards, methods, and procedures for testing product quality and safety.
- Manage technology transfers and method improvements to ensure reliable and cGMP-compliant lab methods.
- Lead the QC lab with strict timelines, delivering reliable analytical results in a regulated environment.
- Support and participate in client visits, audits, and regulatory inspections.
- Establish and meet department schedules and performance requirements.
- Regularly interact with cross-functional leaders on relevant matters.
- Ensure QC team members adhere to safety and cGMP protocols and participate in required trainings.
WHO YOU ARE
- Education: BSc, MSc, or PhD in chemistry, biochemistry, microbiology, or related field (MSc or PhD preferred).
- Professional Experience: 10+ years’ experience in quality control within the pharmaceutical / biotechnology industry. It is preferred for you to have experience with QC startup AND subsequent QC operations leadership, as well as prior experience working with biological and cell therapy products.
- Experienced Leader: You have demonstrated success in leading and developing high-performing teams for over 7 years, as well as experience managing in a matrix organization and collaborating at a global level.
- Required Additional Experience: It is preferred for you to have a strong orientation for quality, compliance, business ethics and customer service and experience leading client site visits, audits, and regulatory inspections.
- Technical Skills: You have Lean Six Sigma experience and/or certification. Technical expertise in biotech processes, leadership, management, and project management is a plus.
- Collaborative: You thrive in a multi-disciplinary team environment and believe that we can get further, faster by working together.
- Detail-Oriented: You have outstanding attention to detail as well as experimental and process rigour. You take pride in your work and strive for excellence.
- Effective Communicator: You are an active listener who can communicate to different audiences in diverse situations.
WHO WE ARE
Aspect Biosystems is a Canadian biotechnology company creating bioprinted tissue therapeutics to transform how we treat disease. Our bold team of innovators and entrepreneurs have joined us from all over the globe to create a new class of regenerative medicine and work towards a future where our bioprinted tissues are used to save lives and make people healthier. We are endlessly curious and wildly passionate about what we do. Every person on our team is a key contributor to our success and is eager to roll up their sleeves to make a difference in the ever-changing world of biotech. If you are committed to making a real impact and accelerating the development of life-changing therapies, we want to hear from you!
WHY ASPECT?
The environment at Aspect is fast-paced, collaborative, ever-changing, and supportive. We are looking for team players who bring substantial expertise and competency in their field. We offer competitive compensation packages and benefits with excellent opportunities for personal growth and career development.
At Aspect Biosystems, we celebrate diversity and are committed to creating an inclusive environment for all employees. All aspects of employment including the decision to hire, promote, discipline, or terminate, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, colour, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, provincial, or local law.