Discover

The Opportunity

Dartmouth, NS
Biotechnology and Pharmaceutical
Experienced
Full-time - Permanent

As part of the Quality Assurance group with IMV and reporting to the Associate Director of Quality Assurance, in this role you will ensure the quality of our processes while supporting our Quality Management System.

This role can be based in Dartmouth, NS, remote or a hybrid working envirnoment.

What you'll do

Responsibilities

  • Work closely with all departments to ensure products and processes conform to internal SOPs, documented procedures, and expected quality levels
  • Review GMP manufacturing and packaging documentation, such as batch records, label proofs, GMP specifications, and certificates. Prepare release documentation for QA Management approval
  • Write and review SOPs, change controls, qualification reports, specifications, protocols, whenever required
  • Conduct vendor qualification activities including initial qualification and ongoing requalification
  • Contribute to maintaining document management and training for quality controlled documents in the electronic Quality Management System (eQMS)
  • Maintain paper filing where applicable
  • Conduct quality training on Quality Management Systems, processes and provides assistance in annual GMP training
  • Support internal and external audits
  • Assist with responses to external, internal and Regulatory audit observations.
  • Oversee closure of quality events in a timely manner through collaboration with the Owning Departments
  • Prepare and assess the procedures associated with the initiation and reporting of deviations/incidents, complaints, self- inspections and CAPAs
  • Provide oversight of the calibration and validation program of equipment and systems with the Owning Departments, maintaining the quality management of equipment
  • Perform other clerical, laboratory, administrative and miscellaneous duties as required and/or instructed by the Associate Director, Quality Assurance

What you'll need

Qualifications

To be successful in this role you;

  • Have excellent attention to detail and high organizational prowess
  • Are able to work in a fast-paced environment, consistently delivering results on time
  • Have strong written and oral communication skills
  • Are self-driven and able to work with minimal supervision
  • Have effective interpersonal and teamwork skills
  • Have exceptional attention to detail and accuracy to maintain compliance
  • Are an analytical thinker with the ability to prioritize tasks and problem solve
  • Excel in a position where you multi-task and work well under pressure and able to adapt to shifting priorities
  • Are able to train effectively and have good presentation skills

Education- Degrees, Licenses, Certifications

  • Completion of a post-secondary diploma or related scientific degree is required (BSc. or higher degree in Chemistry, Biochemistry or Microbiology)

Additional Valuable Education-Degrees, Licenses, Certifications

  • Pharmaceutical training certification or equivalent certification is an asset

Key Experience, Competencies and Skills

  • Minimum 3+ years Quality Assurance and Compliance experience in the pharmaceutical industry
  • Knowledge of FDA/ Health Canada/ EU GMP, ICH guidelines and regulatory requirements
  • Experience with GMP operations, [AE1] [KB2] possessing good understanding of quality assurance and quality control programs, including the QMS
  • Knowledgeable with Good Documentation Practices
  • Computer proficient (MS Office such as Word, Excel, Access, Powerpoint)
  • Data entry experience

The following would be considered assets;

  • Knowledge of GCPs
  • Experience in interacting with Regulatory Agencies in an audit setting and correspondence
  • Working with an eQMS for document management and training

A little bit about us

IMV Inc

IMV Inc. is a clinical-stage pharmaceutical company that has the potential to make history by developing a first-in-class effective T cell-targeted immune therapy for cancer. We have built an unprecedented delivery platform (DPX) that generates targeted immune cells directly into the human body, which produces robust, and sustained capabilities to destroy cancer. DPX is the engine that drives our lead drug candidate, Maveropepimut-S (DPX-Survivac), which has successfully completed multiple Phase 1/1b trials, generating best-in-class results in advanced recurrent ovarian cancer and Diffuse Large B Cell Lymphoma (DLBCL).

Our Platform Enables a Strong, Sustained Immune Response

The unique "no-release" mechanism of action of our DPX Platform allows antigen-presenting cells (APCs) to be attracted to the injection site, facilitating antigen presentation to immune cells. All our immunotherapies and vaccines candidates are formulated with the DPX platform, giving them the ability to generate, in vivo, a targeted, robust and sustained immune response against cancer cells or viruses.

Are you interested?

Work With Us

Please indicate in your application your availability for this position.

Compensation will be determined based upon skill set and experience of the selected candidate and benchmarking for the position.

IMV offers adventagous annual Vacation/Paid Time Off, Employer sponsored Health/ Dental plan, Employee Assistance and Well Being Program, Stock Options, Bonus and Additional Employee Benefits.

If you feel that you are the best candidate for this position, please apply through the "Apply Now" button.

Please clearly indicate in your application how you meet the requirements for this role and why you think you would be the best candidate for the role.

Applications will be considered upon receipt.

*We appreciate your application but only candidates selected for interviews will be contacted. We reserve the right to request interview candidates to complete skill/ behavior based assessments as part of the interview process.

Strong Science Needs Bright Minds

At IMV, we have high standards. And even higher aspirations.

Our drug candidates are helping us build on this promise. Our technology provides the tools that underscore this mission. And our people are the heart of our operation-the ultimate value-drivers upon which we, as a Company, rest.

We Work Better Together

Curing diseases-especially the ones that continue to evade and outpace even the brightest minds in our industry-is hard work. Despite the intensity and ferocity of our business, the one thing we do not have to worry about is the morale and the spirit of our people. We work hard and we play hard. Our people enjoy our drive, our mission and working together. As it turns out, that does make all the difference.