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Director, Quality Systems, Compliance and Risk Management

Date: 25-Apr-2022

Location: Oxford, GB

Company: oxfordbiom

Do you pride yourself on your integrity? We do what’s right for employees, patients and partners, and so can you.

 

Oxford Biomedica’s Quality Assurance team is responsible for the companies quality processes and systems, in compliance with GMP, GLP and GCP guidelines.  The team are accountable for internal and external audits, quality compliance and control.

 

We are currently recruiting for a Director- Quality Systems, Compliance and Risk Management to join the team. 

 

 

Job purpose

 

The Director - Quality Systems, Compliance and Risk Management will be responsible for leading the Quality Systems, Compliance (including CSV - Computerised System validation) and Risk Management (QRM) Programs at Oxford Biomedica. The Director will provide vision and leadership across the OXB sites to meet the changing regulatory and compliance expectations (covering GMP, GLP & GCP activities performed at Oxford Biomedica).

Examples of day to day activities include partnering with the business to resolve complex compliance issues, ensuring procedures are aligned with regulatory and industry expectations, and are consistent across multiple areas, assuring data integrity with paper based and electronic processes, oversees implementation of risk-based strategies, leading operational excellence initiatives including productivity and process improvements with significant impact to the quality organisation and across Oxford Biomedica, ensuring company is inspection / audit ready at all times.

A key component of this role will be Leading, improving, and managing Oxford Biomedica’s Quality Risk Management (QRM) program that includes risk identification, evaluation, reduction, communication, and reviews.

In addition the position is responsible for driving computerised system validation (CSV) compliance, managing identified issues and supporting continuous improvement.

This position requires in-depth understanding of cGMP regulations and guidelines related to Quality Systems (covering GMP, GLP & GCP requirements), Compliance (inc. CSV) and Quality Risk Management principles and proven applications in an aseptic/sterile production environment

 

 

Specific Work Responsibilities and Deliverables

 

  • Promoting a Positive Quality Culture and providing quality direction for complex business and operational issues or technical challenges. Removing barriers as they arise.
  • Working across all GxP functions, leading the establishment, maintenance and continuous improvement of the site's quality system framework to enable the development, manufacture & analytical testing of low bioburden and sterile products.
  • Develop and/or improving quality processes and systems across the product lifecycle including, but not limited to, Document Control, Change Control, CAPA, Deviations, Product Quality Complaints, Training, Annual Product Quality Reviews, Material control & Vendor Assurance, Validation, Calibration and PM activities, Risk Management and management reviews and notifications.
  • Lead, improve, and manage the sites' Quality Risk Management (QRM) program that includes risk identification, evaluation, reduction, communication, and reviews.
  • Lead sites' cultural changes in integrating QRM principles across all GxP functions areas and implement QRM facilitator training program.
  • Establish processes to prioritize risk management efforts across product lines, equipment and processes (including new & existing). Develop, improve, and maintain site risk register, communication plan, and mitigation tracking.
  • Oversee, Track, trend, and analyze quality system data and Monitor Quality Metrics. Ensure data compiled is communicated in relevant forums. Recommend action and continuous improvement plans. Summarize findings and recommendations for management and team awareness and/or present at routine Quality Management Review Forums.
  • Organize and conduct routine reviews of high-risk or high-impact areas to ensure effective mitigation and proactively identify potential risks.
  • Oversee data integrity for paper based and electronic systems, including quality review of audit trail reviews. Ensure compliance with applicable requirements (e.g.  21 CFR Part 11 related to Computerised Systems).
  • Perform inspection readiness preparations (manage and lead the self inspection programs) and / or directly support client and regulatory inspections (covering GMP, GLP & GCP).
  • Lead all aspects of the vendor assurance programme inclusive of initial qualification activities and implementation of ongoing risk based vendor monitoring processes.
  • Creation, Execution and maintenance of Quality/ Technical agreements with company critical subcontractors, service providers and material suppliers and clients.
  • Review and approval for the introduction of new materials and services into the OXB supply chain, inclusive of review of TSE/ BSE documentation, conduction of excipient risk assessments and maintenance of supply chain maps.
  • Identify and lead process improvement projects impacting multiple business areas.
  • Review of new and emerging regulatory guidance inclusive of their timely review, assessment against existing company polices and processes, and execution of any remedial actions to ensure ongoing compliance to industry standards.
  • Mentor, coach and manage staff performance and development of the Quality Systems, Document Management and Training Quality Assurance teams at Oxford Biomedica.
  • Lead critical or large scope risk assessments to ensure sound scientific approach

 

 

Additional preferences

 

  • Must be proficient in Quality Systems & have a clear understanding of the 6 Sub-systems of a modern pharmaceutical quality system (i.e. Quality System, Production System, Facilities and Equipment System, Laboratory Controls System, Materials Systems, Packaging and Labelling System).
  • Influences internal / external customers and senior management, has the ability to identify and solve a range of organisational and operational problems and technical challenges, ale to proactively remove barriers influence a positive quality culture.
  • Must possess a strong working knowledge of local and international GxP (GMP, GLP & GCP) regulations and other policies / regulations as applicable and the ability to interpret these requirements into execution compliance.
  • Must have a thorough understand of data integrity, computerised systems validation per GxPs and understand of system / software development life-cycle concepts.
  • Must have experience in leading medium / large scale process improvement projects
  • Must have the ability to function in a fast-paced environment and communicate effectively cross-functionally, with staff, and management (both written and verbal).
  • Experience interacting with regulatory authorities during regulatory inspections.
  • Ability to self-manage and work effectively with internal & external stakeholders and parties, including regulatory agencies, with minimal oversight.
  • Ability to identify, prioritize, and implement actions to continuously improve operations and systems and manage risks.
  • Must be a strong leader and cross functional team player with ability to work effectively in a fast-paced matrixed environment while managing multiple projects simultaneously
  • Must possess excellent verbal and written communication skills; good interpersonal skills

 

 

Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

 

 

Collaborate. Contribute. Change lives

 

 

No agencies please