Full-Time R&D Quality Manager (Open)
Job Description
Are you a Manufacturing Professional looking for a challenging opportunity to drive Quality Management System improvement and simplification for your local region while working with Quality Managers across the globe? If so, this could be a great position to explore.
As an Operational Quality Manager/Lead, you will be responsible for ensuring effective Regional oversight of the Quality Management System (QMS) in your local region to meet both regulatory and customer expectations. This includes harmonizing the quality standards and simplifying processes while driving both compliance and efficiency.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Performs Scientific Operational Excellence (SOE)n quality oversight on Pre-Clinical Research and Technical non-GMP R&D activities at the R&D site and creates partnership to implement and maintain fit-for-purpose quality standards.
Responsible for ensuring that the activities conducted in the R&D environment are performed in accordance with SOE, GLP, local, corporate and relevant international regulations and guidelines.
Responsible for supporting inspection readiness as needed for the R&D functions.
Ensures stakeholder management with business with regards to the implementation of the SOE standards and represent SOE Quality at relevant R&D global initiatives/projects.
Alone or in partnership designs and executes initiatives to improve efficiency, partnership and fit-for-purpose quality assurance and quality culture at the R&D site.
Role Responsibility:
Represent SOE Quality at the relevant functional and quality governance bodies.
Represent SOE Quality at R&D global initiatives level (e.g R&D QMS)
Leads alone or in partnership design and implementation of SOE quality initiatives.
Operational Quality oversight on non-GMP scientific laboratories operations – input to risk management and management monitoring
Quality oversight on R&D projects according to fit-for-purpose quality standards
Proactive, risk proportioned quality input to R&D non-GMP processes and systems including quality review and approval of relevant written standards.
Quality oversight on non-clinical GLP studies including immunogenicity phase.
Quality Oversight on SOE Equipment and Computerized Systems Management
SOE (non-GMP) Unplanned event/ CAPAs Management as compliance Authority
Local and global Q4R&D Quality Projects support e.g SOE, R&D QMS implementation
Prepare and support the R&D functions for the audits performed by GSK (L2/L3 audit) and/or by external Health Authorities (L4 Audit) as applicable.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree in Pharmacy, Science, or an engineering discipline, Chemistry, biology, bioengineering or pharmacy or equivalent.
Min. 2 years in the pharmaceutical business in vaccines covering various areas: Technical research and development, preclinical, manufacturing.
2+ years of Manufacturing/Quality experience in the pharmaceutical industry.
2+ years’ Experience with the application of Quality Systems in manufacturing, warehousing and distribution.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Master’s Degree is preferred.
Ability to work independently and prioritize workload.
Excellent oral and written communication skills.
Strong interpersonal skills with an ability to enable and drive change.
Problem identification and solving skills.
Experience of working with multi-functional teams.
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigor and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being.
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness.
How to Apply
Please apply directly at the link.66 total views, 0 today