Quality Director - Penylan, United Kingdom - Just Life Sciences

Just Life Sciences

Verified Company

Penylan, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Just Life Sciences are seeking a
Quality Director, for a newly cretaed role within a Global Life Science business in South Wales.

Being responsible for managing an increasing Quality function, you will enable change, provide first class mentorship and further develop, all Quality functions.

Some of your resposnisbilities will include

Manage performance of all Quality functions including Quality Assurance, Validation, Quality Engineering, Change Control, Quality Control, etc.
Develop and execute Quality Management Reviews and continuous monitoring processes.
Ensure adequate staffing and resourcing for all functions within the department.
Engage with BioProcessing leadership team to ensure adequate financial planning, strategic plan development, and risk management.
Recommend measures to improve methods, quality of product.
Recommend and implement changes in working conditions and use of equipment to increase efficiency of the department and manufacturing site.
Prepare and distribute precise and timely reports as required.
Interpret company policies to department workers and enforces safety regulations.
Management Representative for manufacturing site Quality Management System (QMS).
Communicate all deviations and nonconformances to plant management and senior leadership as needed.
Work closely with global quality team.
Establish and oversee internal audit process to ensure site is maintained in an audit ready state.
Communicate with authorities and customers and coordinate the planning and management of audits.
Analyze and approve general and operating procedures, work instructions and other qualityrelated documents.
Ensure qualityrelated complaints are investigated and resolved.

You will have

Bachelor of Science in Chemistry, Chemical Engineering, Biology, or another relevant scientific field (Advanced Degree Preferred)
In depth experience in Quality (QA and/or QC)
10 years of experience in Quality Systems Management
5 years of managing experience
Working in laboratories or manufacturing operations
Good knowledge of validation process
Experience with performing and hosting audits from regulators and customers
Experience in managing Quality Assurance functions with expertise in Continuous Improvement Programs

Preferred Qualifications:

Knowledge of quality assurance requirements for pharmaceuticals: 21 CFR Parts 210/211, ISO 9001 standard requirements.
Knowledge of ISO 19011 standard (the principles of auditing, managing an audit program and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process).
Proven analytical, evaluative, and root cause analysis abilities.
Product development and project management experience.