Manager, Quality Systems and Compliance

BioTalent Canada; Mississauga; On-site; CAD 90,000 - 120,000; Full time

Job summary

A leader in Pharmaceutical Excellence is seeking a Manager, Quality Systems and Compliance in Mississauga, Canada. This role leads the Compliance team to ensure operations meet cGMP standards and oversees quality systems across various business units. Candidates should have a BSc in a related field and 5-10 years of experience in pharmaceutical quality. The position offers excellent benefits and opportunities for professional development in a dynamic environment.

Benefits

Health & dental coverage

Life and disability insurance

RRSP with 3% company match

Paid holidays

Paid time off

Qualifications

• 5-10+ years of experience related to pharmaceutical quality.
• Expertise in cGMP regulations and quality systems development.
• Experience with manufacturing, testing, and validation/qualification.

Responsibilities

• Lead the development and maintenance of Quality Management System for cGMP compliance.
• Manage regulatory and client audits, CAPA oversight.
• Oversee validation and qualification programs for facilities and processes.

Skills

Pharmaceutical quality

cGMP regulations

Lean-Six Sigma

Project management

Microsoft Office

Written communication

Verbal communication

Education

BSc in chemistry, biochemistry, biology, pharmacy

Job description

Join a Leader in Pharmaceutical Excellence – Eurofins CDMO Alphora is looking for a Manager, Quality Systems and Compliance

Are you passionate about driving quality and compliance in a dynamic, science-driven environment? Eurofins CDMO Alphora Inc. is seeking a Manager, Quality Systems and Compliance to lead our Compliance team in upholding and advancing our Quality Management System (QMS). This pivotal role ensures our operations meet and exceed cGMP standards, supporting the development and manufacture of safe, effective pharmaceuticals for both clinical trials and commercial markets.

As a key leader, you will oversee the implementation of robust quality systems across all cGMP business units—including Drug Substance, Drug Product, and Biologics. From managing audits and regulatory submissions to spearheading validation programs and continuous improvement initiatives, you’ll play a critical role in shaping the quality culture of our organization.

What You’ll Lead:

• Development and maintenance of QMS for cGMP compliance
• Regulatory and client audit management, CAPA oversight
• Validation and qualification programs for facilities, equipment, and processes
• Quality metrics, data analytics, and training programs
• Change control, document management, and vendor oversight
• Regulatory support for commercial programs and site licensing

This is more than a compliance role—it’s a leadership opportunity to influence quality excellence and patient safety on a global scale.

Qualifications

The ideal candidate will have:

• Minimum BSc; specialization in chemistry, biochemistry, biology, pharmacy is preferred
• 5-10+ years of experience related to pharmaceutical quality, including previous supervisory experience.
• Experience with pharmaceutical cGMP manufacturing, testing, validation / qualification, and regulatory are expected
• Expertise in cGMP regulations and quality systems development is expected
• Experience with Lean-Six Sigma and continuous improvement are assets
• Proficiency in Microsoft Office (Word/Excel) is required
• Strong written and verbal skills are a priority
• A proficiency for multi-tasking
• Excellent interpersonal skills, with a desire to teach and lead others
• Good time management and project management skills
• A focus on attention to detail
• Be goal orientated and results driven
• A desire to learn and for continuous personal development

Additional information

At Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.

As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at www.eurofins.ca

We thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.