Quality Assurance Compliance Head
Vor 3 Tagen
**ESSENTIAL DUTIES**
- The Quality Compliance Head is responsible for identifying, strategizing, and implementing compliance measures for Quality system. He/she organizes and leads taskforce to address gaps relevant to compliance and other regulatory requirements.- Supports development and deployment of the Compliance Improvement Plans. Builds strong relationships in their respective partnerships, becoming intimate with their mission, processes and requirements. Using robust change management skills, the Quality Compliance Head will communicate across the organization to ensure key stakeholders are aware and supportive of changes and their benefits, at all levels of the organization and locations as required.- 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 energized production and regulatory environments.
- Clearly communicate the cGMP requirements across the organization 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 instill a compliance culture throughout the Quality unit and across functional departments.
- Trains and coach QA Compliance teams on regulatory and relevant requirements.
**OTHER DUTIES AND RESPONSIBILITIES**
- Provides general support for other departments as appropriate, including identification/chartering/prioritization of improvement opportunities.
- Other duties as assigned by Site Quality Head
**MINIMUM QUALIFICATION REQUIREMENTS**
- Bachelors degree in a technical field/science required, advanced degree preferred
- Minimum 7 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
**SKILLS**
- 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 organization, 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.
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