Quality Systems Lead

2 weeks ago

Montréal, Canada 35Pharma Inc. Full time

**35Phama **is a clinical-stage biopharmaceutical company that designs and develops innovative therapeutics for life threatening lung diseases, and musculoskeletal and metabolic disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our highly qualified team of drug developers and company builders has a track record of advancing complex biologics from discovery through clinical trials. Our R&D facilities are located in the heart of **Montréal, Canada**, and comprise laboratory space for pre-clinical research as well as manufacturing development that bolster our mission to serve patients in need.

**Role**:
You will love this role if you have a passion for science and medicine, you thrive in a fast
- paced environment and enjoy contributing to drug development in an integrated communicative team environment.

The **Quality Systems Lead** is responsible for overall development, implementation, operation, and maintenance of the organization’s Quality Management System (QMS). The incumbent will work in conjunction with departments that affect the quality of 35Pharma’s products to ensure meeting regulatory compliance while supporting our corporate growth initiatives.

This is a full-time position reporting to the President and CSO and is based in Montréal.

**Main Responsibilities**:

- Ensure 35Pharma’s organization Quality Management System conforms regulatory/legal requirements to customer, internal and contractors
- Manage the audit program to ensure that vendor compliance with applicable regulations
- Manage the monitoring, measurement, and review of internal quality processes
- Ensure for managing a solid documentation system supporting data integrity
- Audit internal regulatory systems to ensure regulatory audit readiness
- You will develop risk-based strategies and be responsible for the GLP, GMP and GCP compliance oversight of internal and external operations
- Work closely with CMC to review and release clinical product batches and ensure documentation requirements are complete
- Responsible for document control to maintain non-conformities, auditing, monitoring, and change control systems to ensure document integrity, quality, and version control
- Make recommendations to lead management on performance of QMS (e.g., quality audit results, corrective actions), including the necessary improvements to achieve regulatory requirements
- Responsible for ensuring SOP implementation, training, and execution
- Responsible for employee training file maintenance based on established guidelines by Department Directors
- Maintain standards, regulations, issues, and news with respect to product-service quality
- Occasional travel to vendor sites for audits, inspections or investigations may be required

**Qualifications**:

- A bachelor’s degree in engineering, science or quality is preferred, along with at least 5 years of relevant experience in Quality Assurance/Quality Control and at least 2 years of experience managing employees
- Hands on experience in managing a quality system and related expertise in GMP, GCP and GLP regulations
- Experience in regulatory submissions (IND, CTA, IMPD)
- Strong experience in non-conformity investigations
- Excellent communication skills and the ability to work well with people at all levels are essential
- Strong organizational, analytical, problem solving and management skills
- Project management experience is an asset
- Experience with electronic systems validation is an asset

**Perks**:

- Comprehensive group insurance plan
- Paid public transit
- Beautiful office space in Montreal’s Old Port
- Onsite yoga and healthy snacks
- A team and culture committed to learning and high performance

**Contact**:
**Job Types**: Full-time, Permanent

**Benefits**:

- Commuter benefits
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- Paid time off
- Vision care
- Wellness program

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (required)

**Experience**:

- managing a quality system and related expertise in GxP: 5 years (required)

Work Location: In person

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