Regulatory Compliance Manager
vor 1 Monat
About the Role
This is an exciting opportunity to join Haleon as a Compliance Auditor, where you will play a key role in ensuring the quality and integrity of our products and processes.
Key Responsibilities
- Lead Internal Audits
As a Compliance Auditor, you will be responsible for leading internal audits of GSK Nyon plant departments to identify any non-compliance with GSK QMS, National/International GxP requirements, and Local Standard Operating Procedures.
Local Process OwnerYou will be the local process owner for self-inspection, internal and external audits, and will be responsible for defining SOPs and templates according to Global CH guidance.
Inspection ReadinessYou will support Inspection/Audit of Nyon plant by Health Authorities, GSK group (CAG, A&A), Customers and Notified Body (SQS), and will prepare audit and Inspection answers, follow action plan and document action closure.
Documentation and TrainingYou will oversee the design, delivery, development and renewal of the site's documentation program, including both hard copy and electronic documentation, and will ensure that associated documentation (SOPs, Forms, protocols, reports, etc.) are governed by a clear, simple and appropriate process.
Training and DevelopmentYou will design, deliver, implement, and maintain a comprehensive training program for the Nyon manufacturing plant for compliance-based and priority training initiatives to include GMP, EHS, technical production skills, regulatory compliance and new employee on-boarding.
People ManagementYou will be responsible for people management of direct reports which are both independent contributors as well as managers of other associates.
GMP and HSEYou will respect all GxP standards and HSE requirements at Nyon plant, and will ensure that associates respect local GxP and HSE requirements and escalate any significant issue observed.
Qualifications and Skills
- Essential Qualifications
- University degree in Quality Assurance, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
- Pharmaceutical industry specialization.
- Minimum 5 years of experience in the pharmaceutical industry within the quality assurance function.
- Experience in auditing activities.
- Haleon/GSK certified auditor.
- Good interpersonal and leadership skills.
- Safety, Quality, Results and Customer oriented.
- Previous people management experience (either direct or indirect).
- Fluency in French and English.
- Excellent knowledge of GMP and regulatory expectations.
- Excellent communication skills.
- Ability to influence people.
- Role model in GxP, HSE and Haleon values expectation.
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