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.
Essential Functions:
The Clinical/PV Consultant and Auditor, Compliance and Quality Assurance (CQA) position is responsible for supporting the management of compliance and quality assurance related projects and providing consulting and contract services to clients to address quality and regulatory / Clinical / Safety issues, as needed. This position will be assigned to quality assurance GVP / GCP compliance projects within the company. Typical CQA projects include Auditing, QMS development, QA oversight, regulatory agency action response, etc. The Consultant will also be responsible for supporting the conduct, and promotion of ProPharma Group’s CQA program, policies, and strategies in compliance with GVP / GCP regulations and industry trends.
Necessary Skills and Abilities:
- Japanese and English Fluency
- Knowledge of applicable PMDA, US FDA, ICH, EMA, MHRA regulations and guidance documents.
- Expertise in GVP / GCP systems and capable of providing consultation based on previous experience and system knowledge.
- Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and execution of a project.
- Willingness and ability to travel as required.
- Ability to interact in a professional and positive manner with clients and co-workers through strong interpersonal and communication skills.
- Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information / instructions accurately in English and one other European language preferred (for EU employees).
- Ability to manage and execute multiple tasks within the compliance, quality assurance, and relevant Quality and Compliance Consulting services (e.g., QMS development, QA oversight, auditing, cell / gene therapies, regulatory agency action response, etc.)
- Quality orientation and high attention to detail.
- Strong analytical skills.
Educational Requirements:
- Bachelor’s degree, or similar college degree, in a scientific discipline as a minimum
- A graduate degree (MSc / PhD) in a scientific discipline is preferred.
- As applicable, eligible to be registered as a Qualified Person (QP), Responsible Person (RP) and Responsible Person import (RPi).
Experience Requirements:
- Minimum 10 years relevant experience in quality assurance and regulatory / GxP compliance
- As applicable, previous registration as a Qualified Person
- Strong working knowledge of GxP principles and Health Authority regulations.
- For Consultant, CQA roles that are primarily focused on auditing, minimum of 1 year experience leading audits (e.g. audit prep, running the audit, writing final report, etc.) and recent auditing experience is required (at least 5 audits performed in the past year as reflected in the candidate’s audit log).
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.***