Head of QA (Pharmaceutical Industry)

  • Location
    London, Greater London
  • Salary
    £ 75000 - £ 85000 / Year
  • Category
    Medical & Health - Medicine, Surgery, Pharmacy
  • Job type
    Permanent
  • Industry
    Procurement and Supply Chain
  • External Reference
    JN-042020-128538

Head of Quality Assurance (Pharma)
£75-£85k Salary + bonus + car allowance
Based - Richmond, Surrey TW9
Mon - Fri 9am - 6pm
June start
Batchelor degree in Chemistry / Pharmacy
QP Qualified


Role:
To lead and deliver the Quality Assurance Management needs of the company and execute the business strategy through timely and efficient QC and QP release, quality management systems and quality assurance processes.



Duties:


Quality Assurance


Responsible for timely and effective Quality Assurance planning and management, ensuring cost effective and efficient running to deliver the business goals.


Overall responsibility for quality, compliance against GxP and guidelines to meet all regulatory obligations through the provision of adequately trained personnel and designated Responsible Persons (RP) and Qualified Persons (QP) to undertake duties in accordance with current regulations to deliver compliant and safe distribution of medicines.


Delivery of a robust quality management system inclusive of change control, CAPA, deviation processes and employee training programme and records, proportionate to the business activities, is implemented, validated, maintained and monitored.


Overall responsibility for developing and implementing QA related regulatory strategies and planning, managing and executing QA activities for products within Europe.


Establish best QA practices and processes to successfully integrate and manage new product introduction from licensing transactions or co-developments, through to commercial launch.


Ensure resource, process and system are adequate and fit for purpose for QC activities, QA batch reviews and QP release.


Ensure Quality compliance procedures are in place for existing and new suppliers via a riskbased approach for audits, routine monitoring of supplier performance and compliance track record. Regular periodic or rolling quality reviews of all licensed and marketed medicinal products. Identify, manage and resolve shortand long-term quality issues proactively to ensure continuous product supply.


Ensures adequate QA related due diligence processes are in place prior to New Supplier agreement / introduction as well as introduce a process to conduct on-going risk assessment of existing supplier base. Identify risks and opportunities proactively.


All written procedures meet competent health authorities' regulations in existing and new territories.


Ensure company's quality and compliance policies are in place and updated regularly.


Ensure training program is in place and maintained effectively for all staff.


All sub-contract activity sites including testing labs, manufacturing and packaging sites, 3PL providers and QP release services etc are quality compliant.


Skills / Qualifications


Bachelor's degree in chemistry, pharmacy, pharmaceutical science, chemical engineering; or other technically relevant graduate level qualification.


Ideally QP qualified or auditor certified. Direct experience in conducting a broad range of audits, management of QMS and QP release activities.


Current understanding of GMP/GDP/GLP regulations and requirements in the EU.


Good knowledge on manufacturing challenges.


Extensive experience operating in a senior QA management role and managing a successful team with direct reports of more than 4 people.


Expert in QC activities on test and release. Strong problem-solving skills to lead deviation procedures for Out of Specification (OOS) and Out of Expectation (OOE) investigations.


Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.


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Please apply with your CV to: James Wolland