Global Quality & Regulatory Compliance Consultant

What we offer

Ready to dive in the diverse world of Regulatory Compliance?

Joining our consulting team means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

Job Description

The Quality & Regulatory Compliance project leader is responsible to deliver a project on compliance. The function will be related to the gap assessment of vaccine products, from identification up to closure of gaps.
The project leader will work in close collaboration with quality, regulatory, QC and LOC (local operating companies).

The project leader reporting to Global SME Quality Regulatory Compliance, will work in close partnership with GRA Compliance (global regulatory) and is accountable for:

• The timely delivery of the project milestones and internal support behind gap assessment activity to enable timely completion of activity and support for any potential management decisions to be made.
• The leadership of the multi-department core team (regulatory, quality, release, site conformance, local regulatory) and interactions with stakeholders.
• Interact with regulatory and technical teams to ensure file content definition, submission strategy and preparation coordination.
• The review and approval of the Gap Assessments ensuring the transversal alignment and continuous learnings and improvement.
• Lead project-related discussions and provides in-depth strategic, scientific and RA input for technical/CMC and procedural aspects.
• Ensure coordination of activities related to CMC submission file preparation, including change control assessment, source documents collection from key contributing discipline (e.g. QC, Site Conformance, etc), initiation and management of CMC submission kick-off meeting, file authoring, review and approval.
• The lifecycle process linked with change controls, regulatory submissions (central and local files).
• Provide support to the project as needed via critical review of the technical and procedural section of regulatory documents.
• The escalation of risks and issues and communication of the status of the project.
• The project leader may also be required to support on other quality or regulatory projects as needed.

Profile

• Higher degree in Chemistry, Biological Sciences or related field.
• At least 5 years of experience in pharma/vaccines industry.
• Knowledge of Vaccine testing and manufacturing environment.
• Strong knowledge of regulations, guidances (GMP) and industry standards related to CMC processes and post-approval changes.
• Excellent project management expertise, with level of accountability, and drive for success.
• Self-motivated; Sense of urgency.
• Ability to engage, influence and lead people from different areas of expertise, work effectively in a highly matrixed organization across geographies and cultures.
• Must have the ability to work with cross-functional teams and communicate effectively.
• Excellent written and spoken English, French is an advantage.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.