Product Quality Specialist

We are searching for the best talent for a Product Quality Specialist to be based in Belgium, Netherlands, Ireland, or Italy.

You will be responsible for:

• Has end-to-end accountability for the stability management and oversight from late stage development through full commercial lifecycle for a portfolio of products.
• Responsible for product quality related activities with a specific expertise in stability.
• Supporting the work of PQI/PQO/PQL and actively contributing to overall smooth functioning of the Stability CoE
• Be expert in specific areas of stability management
• Operate independent in the PQS role with minimal support
• Support departmental goals and activities
• PQS for Product families that are highly complex or L&G of high value requiring interactions with multiple functions and teams.
• Identify opportunities for improvement
• Mentor less seasoned members of CoE
• Participate in cross-functional meetings as needed
• Support stability related escalations as needed
• Support regulatory filings with stability information/data.
• Responsible for stability Protocols/reports
• Stability SME for assigned product, manage temp excursions, CC etc.

Qualifications/Requirements:

• 6-8 years of industry experience
• Education Bachelor’s Degree
• Ability to work with others in a team environment
• Ability to manage individual assignments with minimal guidance
• Ability to read and interpret documents such as SOPs, work instructions, protocols
• Clear knowledge of stability related regs
• Proficient with using Microsoft office applications and web-based collaborative applications

Preferred Skills:

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

Hybrid work