R&D Risk Manager

One of our clients, a multinational company in the pharmaceutical industry currently requires a Quality & Risk Manager to support the QRM Center of Expertise

R&D Quality and Risk Manager - Center of Expertise

FUNCTION DESCRIPTION

The Quality and Risk Manager (QRM) will have the responsibility to lead the area QRM implementing process and support activities related toquality and risk management.
The QRM will work in partnership with the business across the R&D organization. The Quality and Risk Manager takes in charge, drives and delivers activities listed in the key responsibilities.
The QRM as per his/her level of expertise, seniority and polyvalence will drive and deliver independently.

KEY RESPONSIBILITIES

The QRM takes in charge, drive, deliver one or more of the following activities:

- implementation of support to Business for QC & Management oversight
- risk management and other corporate programs
- implementation of process document simplification and governance
- check relevance and compliance of training curricula
- audits and inspections
- integration and knowledge management of R&D quality matters
- issue Management Team
- review/input into new/updated/draft legislation in collaboration with Regulatory
- collect data, set up reports/dashboard (KPIs, KQI, ...), prepare lessons learned and associated communication
- prepare analysis and build up trends to support knowledge managementand Transversal Quality Forum
- oversee vendors, outcontracted staff (as relevant)

PREREQUISITES

Education

- University Scientific Degree: Master or equivalent
- Qualification in Quality Management or equivalent experience
- General Science or Life Science Degree
- Pharmacy, Chemistry, Bio Engineer, Biology, Bio Medical Sciences.

Knowledge

Hard Skills:

- Design, implementation and delivery of process improvement and educational projects.
- Knowledge and understanding of R&D Policies and procedures and applicable regulatory requirements
- Able to simplify complex situations to enable all parties to play their roles in achieving progress.
- Efficient and good time management skills
- Possesses good English language written and verbal communication skills
- Able to manage workshop and working group, to deliver output
- Work autonomously
- Able to manage challenging project and deliver on time with quality

Soft skills:

- Good team spirit and team player
- Deliver quality work, on time
- Good communication, presentations skills and negotiation skills, ability to interface with multiple partners
- Positive mind-set, able to work in changing and challenging environment
- Enterprise thinking mind set.
- Flexible thinking, build on other expertise

Experience:

- Proficiency in essential regulatory guidelines and procedures applicable to Vaccines R&D.
- Good scientific/pharmaceutical industry background in pharmaceutical research & knowledge of Pharmaceutical R&D.
- 5 to 8 years of experience in Vaccines R&D
- Relevant experience in quality and risk management, compliance, quality assurance, regulations/SOP standards and/or change management.

Tags: Risk Management, vaccines, quality, R&D, pharmaceutical, pharmaceutique, quality and risk, QRM, life science