Quality Audit Manager GlaxoSmithKline

Quality Audit Manager
Requisition ID: 73295
Position: Full-Time Regular
Functional area: Quality and Validation
Location: UK or Europe or Asia Pac, To Be Determined
Required degrees: Bachelor's Level Degree
Relocation: No

Basic qualifications:
Science graduate or equivalent degree

• Knowledge of world-wide cGMPs, regulatory requirements, standards and Quality Management Systems for one or more of the following: pharmaceuticals, biological, bio pharmaceuticals.
• Proficiency & experience in planning, performing & reporting Quality or Regulatory Compliance audits.
• Demonstrated substantial knowledge and experience in sterile operations
• Broad based familiarity with Secondary manufacturing activities
• Risk management knowledge
• Understanding and experience of corporate governance processes
• Knowledge of the pharmaceutical industry current practices in analytical and manufacturing technologies, engineering practices, validation and GMP compliance
• Demonstrated application of continuous improvement, change control and risk assessment
• Serious Incident management with demonstrated ability to resolve quality issues

Preferred qualifications:

• Experience in the manufacture of sterile products gained through working in either a manufacturing or laboratory role.
• GSK Certified Auditor (or progressing through the programme)

Details:
GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.

The External Supply Audit (ESA) department exists to provide independent quality and compliance auditing across GSK’s worldwide network of Third Party Contractors.

ESA is part of the Governance & Advocacy group, providing assurance to Research & Development (R&D), Global Manufacturing Supply (GMS), and the Audit & Assurance community, that significant risk to GSK will be identified and mitigated through the effective auditing of contract partners and other business entities.

This role is part of a team of Quality Audit Managers that reports directly to an Audit Director with responsibility to assure the compliance of assigned parts of the R&D and GSK manufacturing and supply network in line with GSK POL GSK 500 and the appropriate cGMP for the markets being supplied on behalf of GSK.

Key Responsibilities
The primary purpose of this job is to perform and manage GMP compliance audits of Third Party Contractors supplying GMS, Biopharm and Research & Development. ESA will also perform audits of major Logistical Service Providers (LSP) and their Multi-Market Warehouses. In addition audits of specific business processes may be performed as needed. Preparation of clear concise audit reports that ensure senior management is apprised of the identified risks and that appropriate corrective action plans are implemented.

Typical work output will involve:

• GMP audits of contract manufacturing sites, from small single market supply sites up to large, complex, highly regulated global supply sites
• New Contractor Assessments
• Themed audits of business processes
• For Cause audits of third parties based on regulatory actions
• Audits and assessments of progress against risk mitigation plans or regulatory citation commitments

In addition:

• Manage the interface with auditees and stakeholders (the latter may include Site Directors, Site Quality Directors, Heads of Support Functions, General & Quality Mgr of Commercial Companies, Manufacturing & Quality Directors of Contractors)
• Interface with other auditors in the Audit and Assurance Community to deliver integrated audits and the effective communication of risk to auditees and stakeholders
• Update assigned Quality Risk Model elements and maintain Contractor Auditee Profiles
• Support root cause investigations into serious incidents/product recalls
• Promote early visibility of regulatory issues and GSK responses.
• Update assigned Global QMS Documents and Audit function SOPs
• The training and coaching of other auditors (by example during audits or through peer review of reports)
• Support of the Auditor Certification process (either as a trainer or an interviewer)

Additionally more experienced staff may undertake:

• Management of large elements of the audit process with minimal direction from the Audit Director. An example would be the Management of the Pharmaceutical or Consumer Audit schedule for one of the three regions.
• Leading multi-departmental projects
• Management of the interface with senior stakeholders, including Supply Division Heads, Quality Operational Heads
• Although this is a global role, the preferred location for the canidate is Europe or Asia Pac to support manufacturing operations in these regions.

Please apply via the online application system.
Closing date for application : Friday 10th February 2012.

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.

Contact information:
You may apply for this position online by selecting the Apply now button.

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