New Regulatory Affairs Associate QMS Manager - Global PV Operations - Home working available

Employer
Advanced Regulatory (UK & Europe)
Location
UK
Salary
Competitive
Closing date
14 Oct 2020

View more

Discipline
Regulatory Affairs, Project Management, Regulatory Project Management
Hours
Full Time
Contract Type
Contract
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New Regulatory Affairs Associate QMS Manager - Global PV Operations - Home working available

Location: Netherlands

We have a new Regulatory Affairs Associate QMS Manager contractor role for global Pharmaceutical Company with home working options available.

You will be operating in the Global Pharmacovigilance in the Regulatory Affairs department for the Global PV operations in support of global Audit and Inspection readiness with a focus on process, compliance metrics and KPIs and the maintenance of the controlled safety documents (SOP WPD).

Responsibilities:

  • Ensure continuous monitoring on compliance, quality metrics, and timelines while working in close collaboration with internal/external stakeholders (Global PV, JP and EU-QPPVs, RA, QA);
  • Coordinate and support where needed the preparation of audit/inspection responses, and harmonizes the preparation of GPV Corrective and preventive action plans and deviations; provide guidance and support to the GPV functions on the administrative process and evidence collection;
  • Assemble and organize requests for improvement of GPV business processes within the global team, supporting the implementation of new legislation into quality documents;
  • Facilitate the review and approval process of cross-functional SOPs, and WPDs that involves Global PV work- related responsibilities. Support global PV staff of approximately 200 individuals by offering consultation, advice, and subject matter expertise and assists with Regulatory inspection management activities.

The rate is very good and the projects are interesting and the team in International and extremely friendly.  The contract will last 6-12months.
 

To Apply!

To apply, please send a full CV to CV@AdvTalent.com, or alternatively contact Octavian Dinca on +44 (0)207 801 3387. We are assigned these roles by our client and will provide you with support throughout the hiring process.

About Advanced Search & Our Network

Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.

Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.

Our Regulatory Affairs team know their subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.

Contact us today to see how we can help you make that next career move on

+44 (0)207 801 3380

All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-pharmaceutical community.

Advanced Regulatory is a new recruitment organisation. Our consultants are industry known and highly experienced in Regulatory Affairs recruitment. We have assembled a team with competencies in databased contingency recruitment, Search & Selection as well as Creative & Campaign management. Our specialism is Regulatory Affairs. We know that successful submissions are underpinned not by one but many people, all working in cohesion. Whether you require a new career position or a new recruit at junior, mid or senior level, we would like to assist you. Our remit is to provide Regulatory Affairs professionals at all levels to pharmaceutical, regulatory consulting, biopharmaceutical and clinical research organisations.

Contact Us
  • Suite 8 Penhurst House
  • 352-356 Battersea Park Road
  • SW11 3BY
  • GB
  • +44 (0)20 7801 3380
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