The Opportunity As a
Quality Manager for External Quality, you will play a pivotal role in ensuring the safety and efficacy of our products by providing rigorous oversight of our global GxP supplier network. Your contributions will directly impact our ability to deliver life-saving treatments to patients worldwide.
- Serve as the primary Quality Point of Contact (PoC) for designated GxP suppliers, including CDMOs, CROs, and direct material providers.
- Apply deep Quality Control expertise within Pharma s to oversee analytical testing, method validation, and lab compliance at external sites.
- Manage the quality oversight of complex manufacturing processes, specifically focusing on the intricate requirements of large molecules and biologics.
- Oversee critical "Make Assess Release" (MAR) activities, including batch documentation review, investigation resolution, and the release of biological products.
- Lead the development, negotiation, and maintenance of Quality Agreements to ensure strict adherence to Roche and global regulatory standards.
- Drive the resolution of complex quality issues and manufacturing deviations by fostering effective partnerships with external site leadership.
- Utilize advanced quality risk management tools to identify and mitigate compliance risks associated with technical transfers and biologics manufacturing.
Who you are:To be sucessful in this role you
MUST have a
well-balanced background across Quality Assurance (QA)and Quality Control (QC) disciplines. The ideal candidate thrives in a collaborative, fast-paced environment, possesses a deep commitment to regulatory excellence, and brings an equal track record of success in both
quality assurance and quality control.- You possess a Bachelor's degree in Life Sciences or an equivalent field, backed by significant experience in the pharmaceutical or biotech industry.
- You demonstrate robust Quality Control expertise within the Pharma , ensuring high standards of analytical and laboratory compliance.
- You bring specialized experience with large molecules and biologics, showing a deep understanding of their unique characterization and stability requirements.
- You are skilled at managing complex manufacturing processes, with the ability to navigate the technical nuances of biological production cycles.
- You are highly knowledgeable in cGMP, ISO standards, and international regulations governing the manufacturing and distribution of medicinal products.
- You thrive in highly complex environments and are recognized for your ability to organize and prioritize effectively when faced with challenging, high-visibility situations.
- You possess exceptional communication skills, with a proven ability to influence without authority and the transparency to raise concerns timely while remaining receptive to guidance.
Travel:- You are capable of traveling up to 10% domestically and internationally to conduct site visits and support technical transfers or health authority inspections.
**Relocation benefits not available for this position**The expected salary range for this position based on the primary location of Mississauga is 136,936.00 and 179,728.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.
We use artificial intelligence to screen, assess or select applicants for this role.
This posting is for an existing vacancy at Hoffmann-La Roche Ltd.
