Date: 2 May 2025
Location: GB, EC4N 7BL
Company: AdvanzPharma
Job Title: Manager – Quality Audits LCM

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 communication skills, both oral and written, to include senior management in third party suppliers
• Well organised with logical & methodical approach to work
• Sound problem solving skills
• Good organisation & time management skills
• Proven auditing skills
• Excellent interpersonal, communication and organizational skills
• Helpful and flexible with strong team spirit

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