Quality Compliance Head

An exciting Quality Compliance Head job has arisen in a leading firm in Ho Chi Minh City Vietnam.

About this Quality Compliance Head Role:

You will be responsible for identifying, strategizing, and implementing compliance measures for quality system as well as organising and leading taskforce to address gaps relevant to compliance and other regulatory requirements.Using robust change management skills, the Quality Compliance Head will communicate across the organisation to ensure key stakeholders are aware and supportive of changes and their benefits, at all levels of the organisation and locations as required.

Key Responsibilities:

• Takes leadership of Quality Assurance Compliance to ensure a constant state of inspection readiness and that all audit observations are addressed quickly and completely to maintain readiness levels
• Support audit areas to ensure compliance with cGMP, regulatory, and internal requirements
• Participate in risk assessment and minor/major incident investigations in response to any unexplained events encountered during manufacturing or out-of-specification lab results for functional areas
• Provide input and guidance to the team conducting the investigation
• Make recommendations to department management regarding results of investigation and process improvements, when necessary
• Support CAPA system management to ensure that corrective and preventative actions are made and followed up on
• Perform cGMP audits within functional areas by conducting a thorough review of processes and documentation.
• Identify and communicate cGMP compliance deficiencies to Upper Management, recommend appropriate corrective actions when necessary, and perform necessary follow up with respective functional area management to ensure cGMP audit observations are implemented
• Provide support to functional areas regarding the Change Control System by providing assessments, work closure and follow up
• Recommend documentation and supporting data to include in the Change Control Request to ensure that enough information is provided to the Change Control management so that an informed decision can be made
• Interact successfully within the highly energised production and regulatory environments
• Clearly communicate the cGMP requirements across the organisation and routinely evaluate and report on compliance status
• Manages quality compliance projects at global scale with local implementation to ensure timely deployment and successful maintenance
• Acts as a coach and change agent to instil a compliance culture throughout the quality unit and across functional departments.
• Trains and coach QA Compliance teams on regulatory and relevant requirements
• Provides general support for other departments as appropriate, including identification/chartering/prioritisation of improvement opportunities
• Other duties as assigned by Site Quality Head

To succeed in this role, you must have good communication skills in English.

Key Requirements:

• Bachelors degree in a technical field/science required, advanced degree preferred
• Minimum seven years experience in a similar role preferably in pharmaceutical, biotechnology or life science industry.
• A proven record of accomplishments in general and complex quality compliance improvements, team leadership and problem-solving, demonstrated success initiating & managing change.
• Knowledge of compliance risk and other relevant US FDA and EU GMP requirements.
• Excellent & effective English communications
• In-depth knowledge of pharmaceutical manufacturing and QA/QC processes
• Excellent team dynamics skills focused on strong team leadership and participation
• Strong communication skills with all levels of the organisation, emphasis on oral presentation skills, classroom training techniques, facilitation, coaching and feedback.
• Ability to challenge current state and motivated to improve the factory quality processes; ability to influence without authority at all levels of the organization.
• General knowledge of the ICH Q9 and Q12 is preferred
• Drive for results with a sense of urgency
• Ability to assess problem situations and adequately communicate the situation, resolution alternatives, costs and benefits, resource requirements, implications, and recommendations to senior management.

This leading company has an outstanding international reputation in its field. This well-recognised brand offers a great working environment.

If you are driven, determined and want to take the next step in your career, this is the role for you.

Apply today.

Due to the high volume of applications we are experiencing, our team will only be in touch with you if your application is shortlisted.