Network QA Manager

Roche•Mississauga, ON

About The Position

At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. We serve our patients through external partnerships because access to quality products is every patient’s right. We leverage external partners in order to offer flexibility to our internal capacity at the right cost and quality. We enable our external partners to reliably deliver compliant, quality products to our supply chain customers, so that we can deliver to patients worldwide. We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement. The Network Quality Assurance Manager will be a senior and integral part of the Network QA organization, reporting directly to the Network QA Lead. This role is crucial for maintaining stringent quality assurance standards and ensuring the safety, efficacy, and reliability of our products. As our portfolio and network become increasingly diverse and complex, the role of QA oversight is essential to protect patient safety, minimize risks, and maintain the company’s reputation and operational integrity.

Requirements

Advanced degree (BA/BS/MS or equivalent) in Pharmacy, Life Sciences, Engineering, or Chemistry.
12-15 years of progressive, high-impact experience across the pharmaceutical/biotechnology industry, specifically integrating manufacturing, quality, and supply chain functions.
Demonstrated mastery in quality assurance, quality control, and manufacturing operations, evidenced by a verifiable track record of architecting and implementing system-wide efficiency and compliance improvements.
Exceptional and proven matrix leadership capabilities, adept at navigating complex, multicultural, and virtual environments to effectively lead people and business units through significant change and transformation initiatives.
Deep and authoritative understanding of global quality risks, compliance frameworks, complex issue/escalation management.
Successful experience as a key representative in communications with Health Authorities (HA).

Responsibilities

Lead global cross-chapter initiatives for continuous improvement and standardize QA decision-making processes globally.
Foster alignment between Site Quality Assurance Heads in defining and implementing Corrective and Preventive Actions (CAPAs) based on audit findings and quality issues, ensuring timely and effective resolution across all sites.
Drive the oversight, identification, and assessment of QA-related high-risk issues in all PT manufacturing sites and create risk mitigation strategies and execute corrective actions.
Support local functions with compliance, technical issues/counterfeit investigation and ability to effectively communicate with Health Authorities.
Develop strategies to address and mitigate issues effectively, providing comprehensive data and insights, advising the senior decision-makers.
Collaborate with senior leadership to implement global strategic and operational guidance on quality oversight, executing strategies in alignment with the PT strategy.
Take an active role in conducting comprehensive risk assessments for manufacturing processes, proactively identify potential quality risks, and devise strategic mitigation plans in close collaboration with senior leadership.
Act as liaison between global and local QA team to ensure teamwork in aligning on issues.