Associate Director, Product Quality Lead, Quality

vor 4 Monaten

Basel, Schweiz Moderna Vollzeit

The Role
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is solidifying its footprint in Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through mRNA medicines. As we grow our international operations and commercial activities in Basel, we invite global talents to join us in this exciting journey of transforming medicine and impacting lives worldwide.
As the Associate Director, Product Quality Lead in Quality Assurance, you will oversee and ensure the quality of biological products within a franchise. This role involves managing all quality aspects of the product lifecycle, from clinical production, PPQ, submission, and launch to post-market surveillance, ensuring compliance with regulatory requirements and internal standards. You will leverage your strong background in biological products, quality assurance, and regulatory affairs, coupled with proven experience in matrix work and leadership, to drive improvement initiatives that align with current regulatory expectations. The Product Quality Lead (PQL) is a key member of the product team, partnering cross-functionally with teams such as Quality Assurance, Technical Development, Regulatory, Supply Chain, Manufacturing Sciences & Technology, Manufacturing, and Digital to enable efficient communication and strategic decision-making.
**Here’s What You’ll Do Your key responsibilities will be**:
Providing quality oversight and guidance throughout the CMC lifecycle management, focusing on operational excellence and strategic alignment with departmental goals.
Coordinating and supporting regulatory submissions and responses to regulatory inquiries, ensuring alignment with quality standards.
Collaborating with fellow PQLs to align ways of working and standards across the organization.
Developing and implementing policies, SOPs, standard reports, and KPIs in collaboration with senior management for effective process verification and control strategy.
Identifying and escalating significant quality risks, collaborating with senior management to implement timely mitigation strategies.
Representing Quality in cross-functional forums, providing support and oversight to internal manufacturing and testing facilities.
Managing quality aspects of product lifecycle activities within the team, including change control, deviations, and product recalls.
Collaborating with cross-functional teams to support product development and commercialization, ensuring quality alignment.
Driving or supporting significant changes and issue management (Deviations/CAPAs) within internal manufacturing and testing sites.
Coordinating quality activities related to product launch within the QA teams.
Contributing to improvement initiatives within the Quality Assurance team.
Supporting the development of policies and procedures within the Quality Assurance team, in collaboration with quality system business process owners.
**Your responsibilities will also include**:
Leading and managing projects/teams of significant scope and complexity within Quality Assurance.
Engaging in practical experience with Quality Risk Management lifecycle.
Demonstrating a strong ability to navigate through ambiguity and rapid growth while adapting to change.
Implementing a ‘digital first’ and curious mindset to allow continuous learning and challenging of the status quo.
Ensuring robust analysis of complex data and making scientifically sound, quality risk-based recommendations.
Actively contributing to a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
**The key Moderna Mindsets you’ll need to succeed in the role**:
**We pursue options in parallel**: By strategically aligning quality processes and standards, you'll ensure that the best possible choices are available for decision-making.
**We behave like owners**: Taking full responsibility for the quality outcomes, you will guide your team with the same commitment as if it were your own enterprise.
Here’s What You’ll Need ( Basic Qualifications)
**Education**: Bachelor of Science degree in STEM
**Experience**: a minimum of 10 years of experience in pharmaceutical industry
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Significant experience in biopharmaceutical manufacturing/analytics.
Knowledge in risk management and quality system requiremen

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