The Manager Quality Assurance and Regulatory Affairs is responsible for all quality duties to support clients, agency and client inspections, Standard Operating Procedures, quality agreements, product disposition, etc. The role also ensures adherence to current GMPs.
Responsibilities and Accountabilities
The primary responsibilities of this role include:
- Prioritizing and complete multiple projects within established time frames;
- Managing client projects, including managing client relationships and project budgets;
- Prepare, assist and lead agency and client audits;
- Act as quality representative for clients, respond to customer complaints, assist with investigations and disposition of products;
- Maintain product and client files, as applicable;
- Participate in client meetings and teleconferences;
- Attend conferences as appropriate;
- Maintain current GMP knowledged.
May be assigned additional responsibilities described in the job description for Director, Quality Assurance and Regulatory Affairs
- Completion of a life science degree (e.g. BSc, MSc);
- Mininum of 5 years of relevant experience in a quality role required
- Comprehensive experience in Quality including knowledge of current GMP in Canada, US and Europe. Good knowledge of ICH, US and Canadian legislation and regulatory guidance.
- Sound written and oral communication skills, good organizational and planning skills, and effective presentation skills to a variety of audiences.
- Strong computer skills.
- Ability to build positive, production relationships with colleagues and clients.
- Advanced level in written English, intermediate level in oral English. Ability to speak and write French is an asset.
- May be required to develop new departmental procedures or systems and/or monitor the progress of ongoing department procedures
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.
Job Type: Full-time
Salary: $100.00 /hour
- Quality Assurance (GMP): 5 years (Required)
- ICH, US and Canadian legislation and regulatory guidance: 3 years (Required)
- Regulatory Affairs Compliance: 3 years (Preferred)