Head of Quality

Central Pharma; Bedford; On-site; GBP 80,000 - 120,000; Full time

Job summary

A leading company in the Life Sciences industry is seeking a Quality Director to drive their Quality Strategy and ensure compliance with GXP standards. This role involves defining quality strategies, leading the Quality Assurance department, and maintaining relationships with regulatory authorities. The ideal candidate will have extensive experience in Quality management and regulatory inspections, along with a scientific degree.

Qualifications

• At least 10 years of experience in Quality management within Life Sciences.
• Substantial experience in regulatory inspections.

Responsibilities

• Define and implement a quality strategy for products.
• Lead the Quality Assurance department in GXP areas.
• Ensure company is inspection ready at all times.

Skills

Leadership

Quality Management

Regulatory Compliance

Education

Bachelors’ scientific degree

Job description

To drive the company’s Quality Strategy assuring compliance of GXP standards.

Responsible for translating the company’s quality strategy into tactical policies, processes, and procedures to ensure ongoing compliance with meeting global regulatory standards at all times.

Role Responsibilities

• Define and implement a quality strategy for licensed and non-licensed products
• Lead the development, implementation and management of GXP quality and compliance systems and policies
• Lead the Quality Assurance department in all GXP functional areas
• Devise and recommend and implement methods and procedures for continuous improvement of product quality, hygiene and / or manufacturing standards within the Quality Management System
• Develop corporate and/or other organizational polices related to GXP compliance and oversee their implementation, including quality standards and SOPs
• Maintain good working relationships with regulatory authorities and trade associations and become an influencer for laws, regulations and standards whilst planning for future requirements
• Responsible for the overall direction, coordination, and evaluation of the reporting departments (QA, QC, RA, and Validation)
• Ensure company is inspection ready at all times (Regulatory Agencies and Client)
• Plan, coordinate, and direct PAI readiness for new and existing customers
• Ensure products and processes meet all specifications and requirements before approving the release to customers
• Develop and manage relationships with senior Quality representatives from customers, suppliers, and collaborators
• Develop, implement and monitor Quality operation budget to ensure compliance with approved expense limitations. Determine cause of variance to budget and applicable corrective actions.
• Keep current on changes in industry and regulatory standards for GXP requirements and advise on business impact
• Advise Company’s Executive Team and parent company on the implications and risks related to key Quality issues and important strategic decisions; keeping all posted, on a timely basis
• Host regulatory and client representatives in audits and inspections
• Lead and coordinate the efforts within the entire operation to formulate and implement corrective actions to internal and external assessments

The above is not a complete an exhaustive list and other duties may be required to be undertaken as and when necessary.

• Minimum of a Bachelors’ scientific degree (ideally, life sciences or related field)
• At least 10 years of experience in positions of substantial Quality management responsibility within the Life Sciences industry
• Substantial experience in leading and participating in regulatory inspections and preparing staff for regulatory inspections
• Ability to effectively present information to top management, public groups, and/or boards of directors
• Demonstrated ability in setting successful quality strategies and building and leading the function
• Extensive knowledge of pharmaceutical manufacturing processes, equipment, and testing
• Knowledge of relevant regulations, including FDA, EMEA, ICH.

Relationships:

The position reports directly into the Board of Directors and has direct line management of the Quality Assurance and Quality Control teams. The Head of Quality / Quality Director has a direct working relationship with the board and senior management of the organisation.

Success Criteria:

To lead best practice across the organisation, measured on the delivery of quality products to all customers, the service offered by the team to all customers and the improved profile of what Central Pharma consider to be service excellence.