BioResearch Quality & Compliance Pharmacovigilance Manager

Role Overview:

You will have the following areas of responsibility:

• Independently leads the planning, conduct and reporting/follow-up of BioResearch Q&C routine and non-routine PV audits/assessments/inspections of activities, data, internal facilities and processes to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.  
• Non-routine audits include Due Diligence, for cause audits, cross-functional, system/service provider audits as defined by the scope. 
• Manages complex or business critical audits/issues in a supporting or leading role for the region.
• Conducts Peer review of audit reports.
• Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities
• Participates in regulatory inspections in a leadership role (e.g. host, backroom lead).  Identifies training needs and facilitates training for Consumer auditees. 
• Independently advises and coaches other auditors.
• Completes training requirements in a timely manner to ensure inspection readiness at all times.  Leads initiatives and actively participates in key projects.
• Interacts with key stakeholders and is able to influence and effectively drive projects to completion.
• Actively shares business area and regulatory knowledge/expertise for the PV/Safety community within Consumer.
• May act as a primary contact for internal and/or external stakeholders.  Independently provides consultation and advice to Business Partners and the core business sector on quality and compliance processes/procedures, specifically as it relates to PV and safety related activities. 
• Interprets and applies regulations/policies to unique and/or complex issues, when required. 
• Provides strategic input during the development of processes/procedures

Qualifications and experience of the successful candidate:

• A minimum of a Bachelor’s Degree is required. 
• A minimum of 5 years in an R&D, Post Marketing Safety, PV and/or quality and compliance area required. 
• Thorough knowledge of the drug development process and regulatory framework globally of PV/Safety required. 
• Expertise in GVP regulations required.  Knowledge of procedural and records management requirements in a regulated industry required. 
• Prior pharmaceutical, consumer personal products and quality/compliance related experience preferred.  Knowledge of auditing techniques required. 
• Must have excellent communication skills and be fluent in written and spoken English.
• Must be a team player, organized and detail oriented, and possess sound problem solving and good negotiating skills.
• Must be proficient in Microsoft Office applications and possess a Quality mindset.

We Offer:

• Unique opportunity to become part of a global consumer healthcare market leader
• Versatile and fulfilling role in a dynamic and international corporation
• Work in a supportive and highly professional team
• Further opportunities for professional development and career growth
• Motivating financial remuneration & numerous employee benefits