Quality Systems Lead

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

We're looking for someone with at least 5 years of experience in QA, QMS, or validation within the pharmaceutical or biotech sector, along with strong expertise in quality systems, validation lifecycle activities, risk management, and regulatory compliance.

Accountabilities

• Acts as a Quality Assurance (QA) lead for MCM Vaccine B.V. in accordance with Good Manufacturing Practices, Good Distribution Practices and Good Pharmacovigilance Practices guidelines.
• Ensures the appropriate and adequate Quality level at MCM Vaccine B.V. with respect to documentation, procedures and archiving.
• Acts as the Super-User for SciLife (electronic Quality Management System) to ensures archiving and traceability of all operational documentation and maintenance of the digital archive.
• Tracking of Event Management for MCM.  Includes deviations, changes, complaints as identified by the QP, QPPV or GM.
• Tracking of Corrective Actions and Preventive Actions (CAPAs) across all activities to ensure timely completion of actions.
• Coordination and support of preparations related to training.
• Work with the GM and MCM/SP/Merck stakeholders to ensure processes for the JV are maintained at an appropriate level of quality

Other Accountabilities

• Manages access and organisation of the non-GXP MSD Repository
• Leads EU GDPR compliance for all internal processes.
• Propose solutions to increase efficiency in ways of working and support improvement initiatives as required
• PQC reconciliation
• Other activities as may be required by MCM management

Qualifications:

• Ideally 3 years’ experience in a QA or QMS or other Quality-related role
• Ideally Bachelor degree qualification or equivalent (e.g. BSc/BTech)
• Track record of working with high quality, ideally in a role related to GXP
• Strong communication, project management and interpersonal skills
• Strong problem-solving ability, adaptability and resilience
• Demonstrated ability to take the initiative
• Strong collaborator in a matrix environment

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***