Regulatory Product Owner Lead

3 weeks ago

Barnard Castle County Durham, United Kingdom SRG Full time

Job Title: MSAT Drug Product Owner Lead Location: Barnard Castle (Onsite)
Contract Type: Permanent
Time Type: Full-time
About the Role
As MSAT Drug Product Owner Lead, you will lead and develop a high-performing team of Product Owners, fostering collaboration and professional growth. You will provide strategic oversight across the product lifecycle, ensuring quality, effective knowledge transfer, and implementation of the Product Control Strategy. This role involves guiding technical support for manufacturing, resolving operational issues, reducing waste, and overseeing new product introductions and planned changes to ensure smooth transitions to production.
You will champion product and process improvements focused on critical quality attributes, cost efficiency, and performance standards, while promoting risk management and driving corrective actions. Additionally, you will lead a culture of continuous improvement and innovation, advancing digital tools and manufacturing technologies to maintain industry leadership.
Key Responsibilities
Leadership & Team Development: Build and mentor a team of Product Owners, fostering a collaborative, high-performance culture.
Strategic Oversight: Ensure effective product lifecycle management and implementation of the Product Control Strategy.
Technical Support: Provide strategic direction for technical support to manufacturing processes, resolving operational issues and minimizing waste.
New Product Introduction: Oversee preparation and execution of technical transfers and lifecycle changes, ensuring smooth handover to production.
Product & Process Improvement: Drive improvements in product capability, yield, and scrap reduction to enhance cost efficiency.
Performance Monitoring: Promote technical standards and systems to track, trend, and analyze product performance.
Risk Management: Ensure comprehensive risk assessment and action planning in line with the Risk Management System.
Investigations & RCA: Sponsor investigations and root cause analysis for deviations, overseeing corrective and preventive actions.
Culture Leadership: Champion continuous improvement, innovation, and inclusivity.
Digital & Innovation Leadership: Drive adoption of digital tools and advanced manufacturing technologies to maintain industry leadership.
Why You?
Basic Qualifications & Skills:
BSc in Scientific or Engineering discipline or equivalent experience.
Proven capability to lead teams in a technical role.
Comprehensive knowledge of regulatory requirements (MHRA, EMA, FDA) and quality standards.
In-depth understanding of multiple product dose forms and manufacturing processes.
Proven experience in product lifecycle management.
Preferred Qualifications & Skills:
Strategic thinking and planning.
Strong organizational and project management skills.
Ability to lead and motivate teams.
Proficiency in digital tools and technologies.
Innovative mindset and ability to drive change.
Experience in process validation, scale-up, and technical transfer.
Knowledge of internal and external quality and EHS requirements.

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