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Quality Assurance Lead
3 months ago
At Senseability, we are dedicated to fostering a culture of excellence and innovation in the biopharmaceutical sector.
Position Overview
The Quality Assurance Lead will play a pivotal role in ensuring the integrity and compliance of our products within the Canadian market. This position encompasses a variety of responsibilities aimed at maintaining the highest quality standards.
Key Responsibilities:
- Manage the release of imported products for distribution in Canada.
- Supervise the product complaint management process, including the review and approval of investigations.
- Evaluate and approve Annual Product Reports.
- Compile and oversee Yearly Biologic Product Reports, ensuring timely submissions to regulatory authorities.
- Support the maintenance of Drug Establishment Licenses for imported products, including oversight of foreign facilities involved in licensable activities.
- Conduct annual lifecycle activities related to quality products, including batch record reviews and stability assessments.
- Initiate and manage change control and deviation quality records as necessary.
- Ensure compliance with regulatory requirements by maintaining and implementing standard operating procedures.
- Perform audits and qualifications of apheresis and treatment centers to meet qualification standards.
- Assist in the management and training of apheresis and treatment centers.
- Prepare for inspections and actively participate in audits.
- Collaborate with cross-functional teams in Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Commercial sectors to achieve organizational goals.
- Identify and implement strategic initiatives aligned with company objectives.
- Undertake additional responsibilities as assigned.
Qualifications and Skills:
- Bachelor's degree in Life Sciences, Engineering, or a related field.
- A minimum of 6 years of experience in pharmaceutical quality within manufacturing or import/distribution environments; experience with biological drug products is preferred.
- Strong communication and presentation skills, with proficiency in both French and English.
- In-depth knowledge of quality assurance systems, manufacturing processes, and regulatory standards, including Good Manufacturing Practices.
- Ability to adapt to changing priorities and meet deadlines effectively.
- High level of integrity, accuracy, and attention to detail in compliance matters.
- Exceptional organizational skills to maintain productivity and prioritize tasks efficiently.
- Demonstrated initiative and sound judgment.
- Ability to work independently as well as collaboratively within teams.
- Excellent verbal, written, and interpersonal communication skills.
Senseability is committed to advancing innovative solutions in the biopharmaceutical industry, striving to improve health outcomes globally. We are dedicated to creating a healthier world through our groundbreaking research and development efforts.
