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We are currently looking for a Senior Quality Manager to join an expanding and exciting Therapeutics company based in the Oxfordshire area. As the Senior Quality Manager you will be responsible for leading all quality aspects for their UK facility including quality systems, site compliance, regulatory interactions and to lead a quality team. You will support both clinical and commercial products across both the MHRA and FDA.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Quality Manager will be varied however the key duties and responsibilities are as follows:
1. You will oversee and provides direction for the Quality Assurance staff and ensures QA release, compliance and documentation functions are performed effectively. As thje Senior Quality Manager you will also interface with internal customers in Product Development, Quality Control Labs and external vendors.
2. As part of your role you will lead compliance and manufacturing QA functions ensuring the establishment, implementation and maintenance of Quality Management Systems (QMS) in accordance with applicable standards established by FDA, MHRA, and other regulatory bodies in line with GxP. This will include audits, vendor qualification, change control, deviation and investigation management, corrective and preventive action systems, QC release testing.
3. Provide support to Chemistry & Manufacturing Controls (CMC) regulatory activities, to facilitate regulatory approval of the Company's products.
4. Your team, with your involvement, will draft, review, provide oversight to content, and approves controlled documents which may include but is not limited to product specifications, standard operating procedures, validation documents, technical reports, quality policies, etc.
To be successful in your application to this exciting opportunity as the Senior Quality Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a science / life sciences discipline (i.e Pharmaceutical Chemistry / Quality Management / Biological Sciences) with proven experience in a GxP compliant Pharmaceutical / Biotechnology company with a robust QMS. Such experience from a biologics / therapeutics capacity will take priority on application.
2. Proven leadership experience in managing and motivating administrative and technical staff with strong awareness of the interface among Quality Assurance, Quality Control, manufacturing operations, and pre-clinical development, is expected.
3. A working knowledge and practical experience with both the MHRA and FDA would be advantageous on application. However experience to either / or, is acceptable.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.