Head of QA
- Permanent
- Quality Assurance, Auditing
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Hobson Prior are looking for a Head of QA to join a R&D organisation who are focused on offering pioneering oncology and rare disease products to patients. As the Head of QA you will direct, co-ordinate and provide QA oversight for the validation and qualification of all GxP activities at the new facility.
Job Responsibilities:
- You will oversee the generation, implementation and maintenance of a new site quality management system. This will include all critical and regulatory compliant systems, services, equipment and quality processes.
- Create, develop and be responsible for a validation master plan suitable for regulatory inspection by the FDA and EMA which covers all GMP equipment, services and facilities for a new manufacturing facility. This will include the revision of and alignment with any existing validation and qualification practices.
- Generate all new validation documents for the facility QMS including; a site validation policy, all necessary validation and qualification SOPs and work instructions and the risk/criticality assessment for requalification.
- Create a validation function at the new facility which ensures all GMP equipment, services and facilities are suitably validated for any FDA/EMA facility inspection and GMP commercial manufacture.
- Approve all new facility and equipment design packages.
- Develop effective partnerships with internal staff and external organizations to help implement proactive regulatory compliance strategies and controls.
- Audit suppliers and vendors to the new facility as required and set-up an on-going programme of auditing suppliers.
- Support internal investigations and assure the complete and accurate documentation to the required regulatory expectations.
- Develop, implement and maintain the appropriate policy and procedure to Quality Risk Management.
- Recognises opportunities for process improvement and/or process re-design.
- Provides direction and strategy to identify, assess, and remediate quality system risks, and gaps, including conducting corporate gap assessments and development of standards.
- Works with various key stakeholders across the organization to assess all GXP systems and standards needs and to provide resource and support for planning and execution.
Key Skills:
- Leadership.
- Dynamism and self-motivation.
- Motivation of a team.
- High organizational and planning capability.
- Excellent communication and interpersonal skills.
Requirements:
- Masters/Bachelor's degree in Life Sciences degree preferred with a combination of relevant education and applicable job experience may be considered.
- A minimum of 10 years of progressively responsible experience within QA related functions with at least 5 or more years directly leading and being responsible in a GMP QA position.
- Experience should include leading and supporting inspection readiness activities as well as proven experience of interfacing with regulatory authorities.
- Experience of at least 5 years in a leadership or managerial capacity.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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