About ANGLE:
ANGLE is a world-leading liquid biopsy company with offices in Guildford (UK), Toronto (Canada) and Greater Philadelphia area (USA). ANGLE’s patented liquid biopsy platform and associated assays have the potential to be used throughout the cancer care pathway to provide clinicians with individualized, up-to-date, and clinically actionable insight into every patient’s cancer. This could enable patients to receive timely, personalized treatment and improve clinical outcomes.
Join our Team:
This is an exciting time at ANGLE and our research and development facility in Toronto is looking for a Quality Systems Manager to join our Quality Systems team.
The Quality Systems Manager drives and monitors all quality control and quality assurance aspects for ANGLE Biosciences Inc. in support of business needs. The primary function is to maintain and continuously improve the Quality Management System, managing all Quality processes, Quality Management Systems and Quality employees, maintaining ISO 13485 certification, and consistently acting as a champion for infusing a culture of quality across the organization.
At ANGLE, we foster a dynamic, entrepreneurial approach to translating leading edge translational research into clinical diagnostics. We offer the potential for significant corporate growth and career development. We promote a culture of collaboration and shared excellence while encouraging an open and honest exchange of ideas.
We are always in search of potential employees who share our vision and want to make a difference today. In your submission, please describe your background and what you can bring to our team along with attaching your resume.
Principal Accountabilities:
- Manage own and group’s time and priorities, providing daily guidance to the team and maintaining assignment schedules
- Coordinate internal and external audits, implementing resolution of identified observations and non-conformances
- Apply investigative and data collection techniques and work to resolve process issues by reviewing standards and procedures of operation and performing audits as required
- Manage procedures and metrics to monitor and mitigate risk and to ensure product deadlines are met
- Act as the Quality Assurance and Quality Control resident expert, guiding all team members and advising senior management as required
- Coordinate product QC testing and releases in compliance with cGMPs and company SOPs
- Monitor conformance to GMP under Quality System guidelines, compliance with ISO standards and adherence to organizational health and safety policies in the operational processes daily
- Monitor the implementation and maintenance of SOPs in collaboration with other functional departments as needed
- Monitor and control acceptance, release, and quarantine of materials and equipment
- Control qualification of suppliers and organize supplier evaluation meetings
- Control validation of manufacturing processes and equipment qualification
- Coordinate incoming inspection for materials used in Manufacturing and final release testing for all company products
- Control in-house calibration of measuring equipment and coordinate external maintenance and calibration activities
- Ensure full documentation on all QA related issues
- Work closely with R&D in identifying the needs of validation and perform the testing on operation processes, materials or manufacturing equipment as needed
- Ensure maintenance of documents such as QA files, QC inspection records, production batch records, validation documentation, calibrations, supplier notifications, internal change notifications, customer complaint history, and testing/validation reports
- Organize, coordinate, and lead internal and supplier audits
- Participate in, and prepare supporting documentation for the regulatory audits and management reviews
- Manage customer complaints and the CAPA program
- Promptly report adverse events or observed non-compliances to senior management
- Provide detailed analysis of Quality team performance during Management QMS review meetings
- Provide support to R&D in implementation of the New Product Development process
- Implement design controls, verification, and validation strategies in compliance with relevant regulatory guidelines
- Provide support in Quality related activities to all other functions of the company
- Perform such other duties and responsibilities that are consistent with the role of a Quality Systems Manager or as may be assigned from time to time
- Strong leadership skills, ability to demonstrate and foster collaboration between team members and other departments, and make independent decisions
- Effective time management and an ability to delegate work to team members and manage work product delivery
- Strong commitment to continuous improvement of products, processes, employee capabilities, and the production of high-quality results
- A driver of commitment to quality throughout the company
- Strong scientific/technical aptitude
- Strong verbal and written communication skills
- Ability to multitask and prioritize to meet deadlines
- Ability to work both independently with minimal supervision as well as in a team environment
- An eye for detail and commitment to high quality data
- Continuous learner with a keen appetite for cross-disciplinary work
- Possess a flexible, can-do approach to the requirements of the job
- Entrepreneurial thinking and work ethic
Qualifications, Experience, Knowledge and Attributes:
- BSc. in Life Sciences OR an equivalent combination of commercial experience and formal education
- 5 years’ experience working in a regulated environment in the biomedical or pharmaceutical industry
- 1-3 years in a supervisory quality assurance function in an industrial biotechnology or diagnostic company operating in a regulated manufacturing or product development environment
- Experience working in a regulated environment – medical device or pharmaceutical experience with quality system regulations and standards e.g. 21 CFR 820, ISO 13485, 93/42/EEC, IVD 98/79 EC, ISO14971, GMP, GLP and QSR
- A certificate in Regulatory Affairs or Quality Assurance is highly desirable.
- Certified Lead Auditor (or actively working towards)
- Knowledge of Canadian and international regulatory and quality assurance regulations
- Working knowledge of appropriate regulatory requirements (e.g. cGMP, ISO, WHMIS, Occupational Safety)
- Proficiency in Microsoft Office (Excel, Word, PowerPoint)
Job Types: Full-time, Permanent
Benefits:
- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Stock options
Schedule:
- 8 hour shift
Ability to commute/relocate:
- Etobicoke, ON: reliably commute or plan to relocate before starting work (required)
Education:
- Bachelor’s Degree (preferred)
Experience:
- quality assurance: 3 years (required)