Quality Assurance Manager
Intrinsik Corp.
Mississauga, Ontario, Canada
Hybrid Position
Intrinsik Corp., is a North American consulting firm focusing on the toxicology and regulatory challenges associated with the development of new products (pharmaceuticals, biologics, advance cell and gene therapies, consumer products, natural health products and cosmetics). We have an opening for a full-time Quality Assurance Manager. This position is based out of our Mississauga, Ontario, Canada location. This is a hybrid position. This position will be required to come into the Mississauga office weekly.
The Quality Assurance Manager will manage clinical documentation according to client and company guidelines and international government regulations/guidelines and present clinical data objectively in a clear/concise format. The Quality Assurance Manager will ensure the maintenance of Standard Operating Procedures (SOPs) and Work Instructions (WIs) to reflect current practices within the pharmaceutical industry.
We aim to offer our employees an environment that encourages professionalism, creativity, independence, and continual learning. The assets of any knowledge-based company are its people, and we believe strongly in investing in those assets by offering training and mentoring to our employees. We are committed to growing and advancing our employees' careers by providing them with new responsibilities and opportunities within the company.
Responsibilities include:
- Ensure the maintenance of SOPs and WIs, including authoring new SOPs/WIs as necessary and updating approved SOPs/WIs to reflect current practices.
- Manage vendor qualifications.
- Ensure coordination and execution of audits (internal, external, and regulatory authority).
- Manage quality control of the content of outgoing documents and regulatory submissions.
- Review of comprehensive and systematic scientific literature searches, preparing and reviewing tabulated and written summaries of publications.
- Analyze and interpret scientific/clinical data.
The successful candidate would ideally have the following qualifications and attributes:
- Degree in the Life Sciences.
- Postgraduate Certificate in Pharmaceutical Regulatory Affairs & Quality Operations.
- Minimum of 5 years of quality assurance management experience in the pharmaceutical industry.
- Understanding of the drug development process and applicable industry guidelines and regulations (e.g., ICH).
- In-depth understanding of GMP and GCP.
- Proven experience writing quality system documents is mandatory.
- High degree of independence and proficiency with scientific writing and attention to detail.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to multi-task and prioritize workload within a deadline-oriented, fast-paced environment.
- Ability to work both autonomously and collaboratively within a team.
We thank all candidates for applying; however, only those considered for an interview will be contacted by Human Resources.
Job Type: Full-time
Pay: From $70,000.00 per year
Benefits:
- Casual dress
- Company events
- Dental care
- Employee assistance program
- Extended health care
- Flexible schedule
- On-site parking
- Paid time off
- RRSP match
- Vision care
- Work from home
Work Location: In person
