Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from The RFT Group
Global technical recruiter hiring top talent for innovative Biotech/Medtech/Pharma companies.
R&D Process Improvement Lead, Biopharma
Our client, a global Biopharma company with strong product pipeline and commercial products, now have approval to hire an R&D Process Improvement Lead in a 12-month contractor role. This hire will be resident in either Ireland or the UK, with legal authorisation to work from there.
The successful candidate will be responsible for driving process improvement efforts across R&D, to maintain high standards of quality and compliance. Additionally, this hire will support the integration of procedural documents within our eQMS, as part of recent acquisition.
This hire will work closely with R&D Business Process Owners (BPOs) and Subject Matter Experts (SMEs) to develop and author R&D-owned process documents (e.g., SOPs, WIs, etc.).
The ideal candidate will be self-motivated and achievement-oriented, with the ability to operate with cross-functional teams (e.g. Drug Safety, PV, Reg Affairs, Clin Ops, etc.) and changing environment. This person must have a demonstrated track record of driving process improvement activities in similar R&D Pharma / Biotech / CRO setting.
Responsibilities:
* Collaborate with BPOs, SMEs and relevant stakeholders to create or revise process documents.
* Promote continuous process improvement across R&D, in alignment with best practices and regulations.
* Provide process expertise and document guidance to R&D BPOs across multiple functional areas .
* Support the integration of process documents.
* Support BPOs with timely completion of process document periodic reviews.
* Create process maps using Microsoft Visio, as applicable.
* Support the development of training materials as required and Quizzes.
* Promote the use of R&D BPO networks to ensure a consistent approach to process development.
Requirements:
* Bachelor’s Degree in Life Science or similar discipline. Masters or PhD is desirable.
* 8+ years Clinical Development / drug development experience in Pharmaceutical industry GxP, of which 2+ years process improvement experience in a R&D program(s), clinical development, clinical research or scientific research role.
* Proven success in authoring process documents or functioning as a business process owner (preferred).
* Proven track record of driving process improvement activities.
* Strong ability to implement a systematic approach to problem solving and prioritize tasks to meet deadlines.
* Strong networking skills, with the ability to facilitate, collaborate with cross-functional teams such as Pharmacovigilance, Global Regulatory Affairs, and Clinical Operations.
* Strong negotiation skills, routinely demonstrated in a cross-functional setting.
* Strong attention to detail, along with excellent written and verbal communication skills.
* Maintain a continuous process improvement mindset.
* Strong eDMS experience.
* Proficiency with Microsoft Office, including Visio.
Please contact Larry on +353 1 – 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Strategy/Planning, Research, and Engineering
* Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
Referrals increase your chances of interviewing at The RFT Group by 2x
Sign in to set job alerts for “Process Specialist” roles.
Project Process Safety Leader (Life Science Process Safety Center of Excellence) - Remote 1
Carrigtwohill, County Cork, Ireland 4 days ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr