Head of Quality Assurance
Location: London Contract: Permanent Pay Rate: Competitive Salary + Benefits
Would you like to work for a cutting edge scientific research organisation in London?
My client are a Contract Research Organisation specialised in providing biomarker services for global organisations developing innovative therapeutics to address unmet medical need. The work they undertake contributes to the development of these innovative medicinal products.
They attract high-calibre Research Scientists from around the world and are currently looking to bring on board a Head of Quality Assurance.
Key Responsibilities of the Head of Quality Assurance will include;
- Provide oversight, implementation, maintenance and improvement of Quality and Compliance functions across all sites
- Directly manage the quality team to ensure implementation of an effective quality system and supports processes that comply with applicable regulations, Quality Standards (GCP, GCLP, GMP and ISO/IEC15189 - GLP experience would be advantageous) and Policies.
- Collaborate with the International Leadership team to assess impact of new regulatory requirements on processes, and ensure timely implementation of aligned, efficient and least burdensome processes that meet the requirements of the regulations (FDA, EU, ICH M10 & MHRA)
- Lead and manage the strategic and operational performance of the Quality Assurance (QA) department globally, ensuring the successful delivery of business strategy, QA relevant KPIs and objectives.
- Oversee sites in the development and implementation of quality improvement plans, as necessary, that take a risk-based approach in addressing identified deficiencies, corrections and improvements.
- End-responsible for all audit/inspection of QA documents, quality standards, SOP and analytical methods, as well as the audit of relevant documents related to QA department. Responsible for ensuring that all sites are "audit ready" by implementing appropriate programs to ensure compliance with applicable regulations, company policies and standards and for providing guidance, support and resources to address identified deficiencies.
- Ensure that QA standards are met in all areas of R&D, validation & clinical sample analysis and provide guidelines to projects and programmes. Should be proactively identifying current gaps and establishing innovative processes to improve quality management processes.
To be considered for this Head of Quality Assurance vacancy, you will need the following skills and experience;
- A degree in Biological Sciences (preferably immunology or cell biology) with significant experience in relevant biopharma industry
- Has good knowledge of analytical testing, as well as expertise in analytical method validation, method transfer and clinical sample analysis. An excellent knowledge of GCP, GCLP, GMP and ISO/IEC15189. Knowledge of GLP practices would be a strong advantage.
- Significant experience in Quality Assurance environment with strong scientific, regulatory and compliance background
- Strong leadership with proven experience that can form a strong, diverse teams of people with multiple perspectives and talents.
- Should be fluent in English (read, written, spoken). Business proficiency in written and spoken English.
- Ability to handle pressure, interact and function in a highly productive work environment.
- Ability to maintain composure and focus on situations of ambiguity and uncertainty.
- Attention to detail and critical thinking.
Note: Home-based work max 3 days a week. Regular travel between all Laboratory sites for internal and external on-site inspections and audits would be required.
If this role profile sounds like what you want to do next, and your CV proves you have the necessary skills and experience to do it, then please apply now through the link or contact Umul Ahmed for more information: firstname.lastname@example.org
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