Quality Systems Lead
- Recruiter
- Confidential
- Location
- Morpeth
- Salary
- Competitive
- Posted
- 20 Jun 2022
- Closes
- 18 Jul 2022
- Sectors
- Health, Nursing & Social Care
- Contract Type
- Permanent
- Hours
- Full Time
Leading Pharmaceutical Development and Manufacturing Company based in Northumberland seeks an experienced Quality Systems Lead.
About the role:
To lead a team that collectively, is responsible for administering and delivering the Pharmaceutical Quality System (PQS) across the facility.
Maintain and develop systems and processes that proactively keep the site ahead of the curve in changes to legislation, technology and risk-based approaches. Drive a quality culture within the business that embraces continuous improvement.
Duties may include:
Lead and develop a team to deliver a robust, supportive, Quality System for the organisation that complies with ICH (Q7, Q9 & Q10), CFR 210 & 211, EU GMP and UK GMP.
In conjunction with the Head of Compliance and Technical Quality, manage and develop the following systems and processes on site
Experience of Change Management - Effectively manages change by explaining the context, rationalising the requirement(s), answering questions and mitigating any issues.
Strategic agility - Provides clarity and focus on key priorities to deliver on time and in full.
Proven project management skills - working with a variety of different systems and stakeholders to deliver commitments to the necessary quality standards.
Decision making - Pushes decision making to the lowest appropriate level and develops employees' confidence in their ability to make those decisions.
Relevant and demonstrable experience within the Pharma or Healthcare sectors
Skills and experience:
Excellent knowledge of GMP and GDP, such as the MHRAs Orange and Green Guides, EUs Eudralex Volume 4, USAs CFRs, ISO, ICH, and PIC/S.
Significant experience within the pharmaceutical industry, working to GMP, ideally in a similar position.
Substantial (SME-level) knowledge of Data Integrity requirements
Formal line management experience
Degree educated in a relevant field
About the role:
To lead a team that collectively, is responsible for administering and delivering the Pharmaceutical Quality System (PQS) across the facility.
Maintain and develop systems and processes that proactively keep the site ahead of the curve in changes to legislation, technology and risk-based approaches. Drive a quality culture within the business that embraces continuous improvement.
Duties may include:
Lead and develop a team to deliver a robust, supportive, Quality System for the organisation that complies with ICH (Q7, Q9 & Q10), CFR 210 & 211, EU GMP and UK GMP.
In conjunction with the Head of Compliance and Technical Quality, manage and develop the following systems and processes on site
Experience of Change Management - Effectively manages change by explaining the context, rationalising the requirement(s), answering questions and mitigating any issues.
Strategic agility - Provides clarity and focus on key priorities to deliver on time and in full.
Proven project management skills - working with a variety of different systems and stakeholders to deliver commitments to the necessary quality standards.
Decision making - Pushes decision making to the lowest appropriate level and develops employees' confidence in their ability to make those decisions.
Relevant and demonstrable experience within the Pharma or Healthcare sectors
Skills and experience:
Excellent knowledge of GMP and GDP, such as the MHRAs Orange and Green Guides, EUs Eudralex Volume 4, USAs CFRs, ISO, ICH, and PIC/S.
Significant experience within the pharmaceutical industry, working to GMP, ideally in a similar position.
Substantial (SME-level) knowledge of Data Integrity requirements
Formal line management experience
Degree educated in a relevant field