Quality Assurance Senior Specialist (Contract)

GENERAL POSITION SUMMARY:

The Senior Quality Assurance Specialist Vertex Canada holds primary responsibility and accountability for providing comprehensive quality oversight of all product distribution activities within Canada. This pivotal role specifically manages GMP release of products ensuring strict adherence to Vertexs SOPs internal policies and relevant industry guidance.

This position requires extensive collaboration and interaction with both internal cross-functional teams at Vertex and the external network of Contract Manufacturing Organizations and contract laboratories. The core objective is to ensure that all activities related to product quality and distribution in Canada fully comply with cGMP / GDP. Furthermore this role is crucial in ensuring that all necessary quality systems are robustly established and consistently maintained to support Canadian operations.

This is a 12 - 18 month contract.

Hybrid

KEY RESPONSIBILITIES:

The responsibilities of this position may include but are not limited to the following:

• Take ownership and provide support on QMS processes (Deviations CAPA & Change Controls) including Root Cause Analysis Risk Assessment Action completion and timely closure of records.
• Support the intake triage and logging of deviations & distribution complaints into the Veeva electronic Quality Management System (VeeQMS).

• Ensure that Canadian quality system documents SOPs Quality Agreements SMFs are compliant up to date and accurate.

• Liaise with relevant stakeholders to obtain full information to initiate investigation and root cause analysis as per Vertex procedures. Track completion and closure in a timely manner.
• Prepare materials for distributor sites to monitor performance on deviations cascade information and follow up on outstanding items.

• Manage the release and Batch certification of all the Vertex Canada Commercial products for sale to the Canadian Market.

• Support MQ with SOP processing through Veeva.

• Support the maintenance of the Vertex Canada Drug Establishment License.

• Raise risks/issues with timelines and seek support in timely resolution.
• Support change control records as required and complete any quality actions assigned.
• Prepare relevant QMS data reports/KPIs on Deviations CAPA Change Controls and Effectiveness checks for Affiliate QMRs inspections ad hoc data requests and other governance meetings.
• Support creation of and update to Quality Agreements with Vertex Canada and external vendors by drafting using global templates collation and amendment based on review comments collection of approval signatures via DocuSign & upload to the VeeDMS system.
• File quality records according to Vertex records retention policy and procedures.
• Support internal audit or external audit programs and inspection readiness activities as well as tracking post-inspection readiness.
• Support GDP operational quality in gathering relevant documentation for disposition on temperature excursions.
• Support Self-Inspections preparation performance and closure of deficiencies identified.
• Support products Recall in Canada and annual Mock Recall as per the Global schedule.

MINIMUM QUALIFICATIONS / SKILLS:

• Must be a resident of Canada.
• Bachelors Degree preferably in life sciences or a technical discipline.

• Expertise in GxP Regulations demonstrated working knowledge and practical application of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). This includes deep familiarity with Canadian US and international/global regulatory requirements and associated guidance documents and standards across diverse modalities (e.g. small molecule device biologics cell & gene therapy).

• Direct experience with the GMP release of pharmaceutical products
• Excellent organizational and time management skills and able to demonstrate flexibility and adaptability.
• Able to prioritize workload decisive thinker able to work within agreed timescales.
• Highly adaptable and flexible with the ability to thrive in a fast-paced environment and consistently act with urgency.
• Proactive approach and strong critical thinking skills.
• Excellent verbal and written communication skills with a high level of attention to detail.
• Utilizes available digital tools and systems to enhance QA performance and efficiency.
• Ability to collaborate cross-functionally across all levels of the organization.
• Ability to drive results.
• Continuous Process improvement mindset.

PREFERRED QUALIFICATIONS:

• Degree in pharmacy chemistry medicine biology or a related life science.
• GDP & GMP work experience or relevant comparable background.
• Experience with processing deviations and CAPA in an electronic QMS tool such as Veeva or equivalent.
• Fluency in English is required.
• Proficiency in using Microsoft Office applications required (MS Word MS Excel MS PowerPoint).

$50-$53/HR

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements

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No C2C or Third-Party Vendors