Head of Commercial QA - Operations

Head of Commercial QA - Operations

Job Title: Head of Commercial QA - Operations
Contract Type: Contract
Location: Kent, England
Salary: Negotiable
Start Date: ASAP
Reference: HOQA01_1500398447
Contact Name: Nathan Wilson
Contact Email:
Job Published: July 18, 2017 18:20

Job Description




Member of Quality Leadership Team

Reporting to

Site Head of Quality

Direct Reports

Quality Manager (Field QA), Qualified Persons, Senior QA Executives

Role Scope

Establishment and leadership of a new QA Operations Team in support of global Commercial Supply Chain. To manage the QA activities associated with increased batch volumes for leading product, in particular the activities associated with API and Medicinal Product launch inventory and subsequent 5-year commercial supply chain demand. To ensure that the manufacturing, control, storage and distribution of commercial products are undertaken in accordance with global regulatory requirements and that own facilities are inspection ready by US FDA, EMA and UK MHRA. To support 5- Year Supply Chain Plan in particular the capacity expansion and new facility build projects located in Kent.

Key Objectives:


Quality Operations & Management

  • To establish, recruit and lead a team of QA professionals (including a Field QA Manager and Qualified Persons) to support the manufacture, control and release of commercial products.
  • To manage the QA activities associated with the production of Commercial API and Medicinal Products at Manufacturing Facilities and to ensure that all associated activities are undertaken in accordance with the requirements of cGMP Quality Management System (QMS).
  • To ensure that the facilities in support of the above are maintained in accordance with cGMP, all equipment is verified as clean and all processes are validated/ continuously verified in accordance with current guidance.
  • To ensure that all supporting documentation (to include specifications, master batch records etc.) is appropriately reviewed and approved as suitable for use.
  • To establish the Commercial Control Strategy for each Medicinal Product (to include CQA/ CPP/ MQA) in conjunction with the Technical Development and Manufacturing teams.
  • To establish an increased presence of 'Field QA' within production operations and introduce an approach to on-going, parallel batch record review.
  • To ensure that all deviations, out of specification and other quality events are investigated (including root cause analysis), remediated and trended to ensure appropriate corrective/ preventive actions are effective. This includes deviations and quality events arising from own production activities as well as those undertaken at CMOs.
  • To ensure Medicinal Product is released for clinical/ commercial use in accordance with regulatory expectations, the Regulatory File (NDA/ MAA) and by a Qualified Person (QP).
  • To collaborate with appropriate departments to ensure that all commercial manufacturing activities are inspection ready by US FDA, EMA and UK MHRA.


Quality Operational Excellence

  • To ensure commercial manufacturing operations remain current with new global cGMP regulatory requirements. To support the provision of associated team training, as appropriate.
  • To ensure that the content of the Quality Management System (QMS) in support of commercial manufacturing operations is robust, stream-lined and compliant.
  • To review, in conjunction with the Site Head of Quality, the provision of quality performance metrics (KQI) for operational implementation.


Quality Compliance

  • To support the assessment of customer complaints.
  • To ensure the completion of the Annual Product Reviews.



  • To provide Quality support and oversight for assigned projects.

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