Director Country Head Quality Assurance - UK Ireland
Director Country Head Quality Assurance - UK Ireland
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Job Description
The Role
Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.
As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.
Modernas 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 presence in London a global hub for scientific research and innovation. Our London office focuses on commercial operations ensuring the delivery of our revolutionary products to the UK market. Were seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide.
We are seeking a decisive and knowledgeable pharmaceutical quality leader to serve as Director Country Head Quality UK & Ireland. This Londonbased role oversees Modernas pharmaceutical quality operations across the region and plays a key leadership role in delivering our UK commercial and government partnership commitments. As the Responsible Person (RP) and/or Responsible Person for Import (RPi) on the wholesale distribution license you will ensure the companys operations comply with all applicable GxP standards and EU GDP requirements. You will act as the primary quality interface with authorities logistics partners and internal stakeholders while embedding Modernas enterprise quality vision at the local level.
You will also lead a dedicated quality team overseeing product distribution batch monitoring and strategic quality initiatives all within a highvelocity innovationdriven culture. This is a role for a quality professional who brings precision leadership and deep regulatory knowledge with the opportunity to engage with enterprise digital systems and contribute to Modernas broader Quality evolution including futurefacing initiatives that touch AI and automation.
Heres What Youll Do
Your key responsibilities will be:
Serve as the Responsible Person (RP/RPi) under EU Guidelines 2013/C 343/01 ensuring QMS implementation and GDP compliance.
Act as the Management Representative for the UK market reporting on product quality and compliance.
Lead the integration of quality functions for of UK government contracts and participation in the UK Quality Council.
Oversee distribution system implementation (contracts specifications transport conditions etc. and ensure endtoend product integrity.
Ensure local implementation of Modernas global Quality System aligning SOPs CAPAs KPIs audits and regulatory reporting.
Maintain oversight of warehousing and thirdparty logistics providers including complaints deviations and sample monitoring.
Prepare for and manage inspections certifications and audit readiness across the UK & Ireland.
Your responsibilities will also include:
Decisionmaking on returned rejected recalled or falsified products including batch disposition and approval of product returns.
Management of customer complaints training internal selfinspections and supplier qualification.
Stock monitoring including forecasting risk declarations authorizations to distribute and handling of potential shortages.
Maintain rigorous documentation and training compliance in accordance with Good Documentation Practices and Data Integrity principles.
Ensure continuous improvement and crossfunctional collaboration to promote a strong quality culture within the local affiliate.
Lead and develop a highperforming quality team fostering collaboration and compliance excellence.
Integrate local regulatory requirements into the enterprise Quality Management System and liaise effectively with global Quality functions.
The key Moderna Mindsets youll need to succeed in the role:
We behave like owners. The solutions were building go beyond any job description:
You will be the face of Quality for the UK & Ireland ensuring Modernas standards and the publics trust are upheld at every step. This mindset is vital in managing complex stakeholder relationships anticipating risks and executing with a deep sense of ownership across the system.We digitize everywhere possible using the power of code to maximize our impact on patients:
From electronic quality systems to data tracking your leadership will help digitize Modernas operations locally. Youll embrace opportunities to integrate AI and automation into routine workflows inspections and quality analytics pushing quality innovation forward.
Heres What Youll Need (Basic Qualifications)
Education: Minimum: Bachelors Degreein relevant scientific discipline.
Experience: Minimum: 10 years significative experience within the pharmaceutical industry (quality regulatory and pharmacovigilance area)
Soft Skills: Influence others internally and/or externally including other functions. Negotiation skills. Problem solving oriented.
Demonstrated aptitude or ability to learn: Able gain a strong understanding of GxP regulations.
As part of Modernas commitment to workplace safety this role may require an enhanced preemployment check.
At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and wellbeing resources are designed to support youat work at home and everywhere in between.
- Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to wellbeing
- Free premium access to fitness nutrition and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary yearend shutdown
- Savingsandinvestments
- Locationspecific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010 we have aspired to build the leading mRNA technology platform theinfrastructure to reimagine how medicines are created and delivered and a worldclass team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission values and mindsets every day our peopleare the driving force behind our scientific progress and our we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.
As we build our company we have always believed an inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine we invite you to visit modernatx/careers to learn more about our current opportunities.
Moderna is a smokefree alcoholfree and drugfree work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!
Moderna is committed to equal opportunity in employment and nondiscrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at .
#LIJP1Required Experience:
Director
Employment Type
Full-Time
