Manager, Quality Systems and Compliance - Eurofins CDMO Alphora, Inc.
Manager, Quality Systems and Compliance - Eurofins CDMO Alphora, Inc.
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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 unitsincluding Drug Substance Drug Product and Biologics. From managing audits and regulatory submissions to spearheading validation programs and continuous improvement initiatives youll play a critical role in shaping the quality culture of our organization.
What Youll 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 roleits 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.
Accommodation: Persons with disabilities who need accommodation in the application process or those needing job postings in an alternative format may e-mail a request via the website at .
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
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.
This posting is supported by AI technology to assist in screening candidates and resumes.
NO AGENCIES CALLS OR EMAILS PLEASE
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
