Quality Manager - Audits

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Job Title: Manager – Quality Audits

Location:
London

About ADVANZ PHARMA

ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing the specialty, hospital, and rare disease medicines they depend on.

Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.

Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.

ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.

We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.

Main purpose of role:

• Leadership, management and mentoring of direct reports
• Lifecycle Management of Advanz Pharma’s approved vendors/suppliers in accordance with the appropriate industry regulations and guidelines
• The role requires cross-functional/departmental interactions working closely with Supply Chain, Regulatory, and Quality colleagues to ensure qualification activities are aligned to business requirements
• This role will require national and international travel
• Deputise for Senior Quality Manager – Supplier Assurance as required

Key responsibilities:

• Establish objectives, KPIs and evaluate and report associated metrics
• Establish, maintain and monitor a risk-based audit programme for vendors/suppliers used in Advanz Pharma’s products (excluding Pharmacovigilance suppliers/partners)
• Perform a risk analysis-based outcome on Quality audit and liaise with QPs and management on future actions.
• Ensure audits are carried out such that assurance is provided for all vendors/suppliers in accordance with current EU GMP, EU GDP or equivalent, and the relevant marketing authorisation (MA)
• Monitor and maintain CAPAs (both internally and with external suppliers)
• Responsible for maintaining vendor validity in the SAP ERP system
• Evaluate and interpret global regulations for audits
• Create, revise and review documentation related to QA audit checklist, questionnaire etc., and other system SOP’s / guidance documents as required by the management
• Other activities as may be required at the discretion of the Senior Quality Manager – Supplier Assurance as required

About You

We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives.

For this role, you will also have the following:

Knowledge, Skills & Experience:

• Graduate in Chemistry, Pharmacy or Microbiology or equivalent
• General Auditing Qualification
• External Lead Auditing Qualification
• Minimum 5 years’ experience of working in a similar role within a pharmaceutical company
• Experience and auditing against with the directives and guidelines for medical devices
• Experience and auditing sterile manufacturing facilities
• Experience and auditing against with the directives and guidelines for biosimilars
• Able to travel globally
• Capable of working to deadlines & remain calm under pressure
• Proven ability to organize and prioritize multiple tasks
• Ability to work on own initiative & juggle priorities
• Ability to make decisions based on risk
• Ability to work effectively as part of a team
• Excellent…