Technical Manager

Moderna, Inc.; Milton Keynes; On-site; GBP 55,000 - 75,000; Full time

Job summary

A leading biotechnology company in Milton Keynes seeks an experienced QA professional to provide strategic quality oversight in QC laboratories. You will play a crucial role in ensuring compliance with regulatory standards while fostering a culture of innovation and continuous improvement. The ideal candidate has over eight years of experience in the Biopharmaceutical industry, excellent leadership skills, and a solid understanding of cGMP regulations. This position offers a competitive salary, comprehensive benefits, and the opportunity to contribute to groundbreaking mRNA technology.

Benefits

Quality healthcare and insurance benefits

Generous paid time off

Free access to fitness and mindfulness classes

Qualifications

• 8 – 10+ years of experience in the Biopharmaceutical or Pharmaceutical Industry within Quality.
• Experience with regulatory inspections as a Subject Matter Expert.
• Strong working knowledge of relevant regulatory guidance documents.

Responsibilities

• Provide strategic and operational quality oversight to QC laboratories.
• Lead QA review and approval of laboratory-related documentation.
• Support continuous GMP compliance and conduct risk-based QA decision-making.

Skills

cGMP regulations

Project management

Leadership

Risk management

Communication

Education

Bachelor's Degree in a scientific field

Job description

Overview

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's mission is to establish a leading‑edge research, development, and manufacturing facility at Harwell, as part of a long‑term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic, NHS and government partners across the UK. We're looking for global experts eager to join us in this endeavour, contributing to a future where access to life‑saving vaccines is a reality for all.

Key Responsibilities

• Provide strategic and operational quality oversight to QC laboratories at Harwell, aligned with Moderna's global quality framework.
• Ensure QC methods, processes, and SOPs are scientifically robust, validated, and aligned with regulatory expectations (e.g. ICH Q2 (R2), USP/Ph. Eur.).
• Lead the QA review and approval of laboratory‑related documentation, such as SOPs, analytical reports, Annual Product Quality Reviews, and trend analyses.
• Oversee qualification, validation, and transfer of analytical methods to internal and external labs, ensuring lifecycle management and scientific integrity.
• Support continuous GMP compliance by ensuring adherence to Good Documentation Practices and Data Integrity standards.
• Oversee and support OOS/OOT investigations to ensure they are prompt, unbiased, scientifically justified, and concluded with effective CAPAs.
• Conduct on‑the‑floor QA oversight via lab walkthroughs, data reviews, and staff coaching.
• Lead inspection readiness efforts and actively participate in hosting MHRA, FDA, and other regulatory inspections.
• Monitor training, qualification, and competency records for QC personnel to ensure compliance.
• Perform risk‑based QA decision‑making using ICH Q9 principles.
• Oversee quality aspects of external/contract laboratories, including qualification and performance monitoring.
• Execute trend analysis of QC data and verify CAPA effectiveness.
• Maintain alignment with other Moderna labs (Norwood, Madrid, Resilience sites) and ensure harmonisation where possible.
• Foster an inclusive and quality‑focused team culture that values collaboration and continuous improvement.
• Ensure task execution follows internal SOPs and global policies precisely and compliantly.
• Participate in on‑call rotations or shift coverage when required to support 24/7 manufacturing operations.
• Additional duties as assigned in alignment with evolving site priorities.

Key Mindsets

• We behave like owners. The solutions we're building go beyond any job description. This role requires you to take full ownership of QC oversight‑supporting lab staff, influencing documentation practices, and escalating critical issues—all with a proactive and leadership‑driven mindset. You will represent QA in cross‑functional environments and be seen as a trusted authority.
• We digitise everywhere possible using the power of code to maximise our impact on patients. With Moderna's strong focus on innovation, this role offers opportunities to adopt digital quality systems and analytics platforms to enhance compliance and drive more agile decision‑making in QC oversight.

Education & Experience

• Education: Bachelor's Degree in a scientific field.
• Experience: 8 – 10 + years of Biopharmaceutical / Pharmaceutical Industry within Quality.
• As part of Moderna's commitment to workplace safety, this role may require an enhanced pre‑employment check.

Preferred Qualifications

• Strong working knowledge of cGMP regulations, ISO standards, and other relevant regulatory guidance documents.
• Experience with regulatory inspections as a Subject Matter Expert (SME), including direct interactions with worldwide health authorities.
• Demonstrated experience in analytical or microbiological method validation.
• Experience with OOS/OOT investigation management, risk management, and digital quality systems.
• Strong leadership skills with ability to develop, mentor, and motivate diverse teams.
• Excellent project management, organisational, and communication skills.
• Experience interacting with regulatory authorities during regulatory inspections.
• Demonstrated ability making risk‑based decisions.

Benefits

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well‑being
• 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 year‑end shutdown
• Savings and investments
• Location‑specific perks and extras

Equal Opportunity Statement

Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person's 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. We're 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 [e-mail].